Getting poised for a steeper growth curve – Special Report: Generic Drugs

Getting poised for a steeper growth curve – Special Report: Generic Drugs – Industry Overview

Michael Johnsen

New YORK — The winds of change have begun to fill the generic drug industry’s sails. Driven by expiring patents on big-selling blockbuster drugs and the frantic search for lower-cost prescription alternatives by health plan payers, generic utilization rates have grown roughly 6 percent by volume over the past two years, and are projected to maintain that pace through 2005, according to research from Merrill Lynch. Indeed, the Wall Street firm projected overall sales growth of at least 13 percent in each of the next three years.

That rosy projection for generics is borne out by new research from IMS Health–at least for 2003. “It’s going to be a very good year for generic drugs, because [the industry] will have a full year of patent expirations [from 2002]behind it,” said Doug Long, IMS vice president of industry relations, in a presentation at the Generic Pharmaceutical Association’s 2003 Annual Meeting late last month. “It’s hard to imagine things going better for the industry than they are right now.”

However, said Long, that won’t necessarily translate to a solid, uninterrupted growth rate over the next five years. He pointed to a dearth of expected patent expirations over the next two years, continuing efforts by brand-name drug makers to slow generic competition and growing difficulties among me-too drug manufacturers in obtaining raw materials from overseas. “I think this is going to be a weak year for patent expirations,” he cautioned .generic industry leaders at the GPhA conference. “You seem to have a lot of things aligned right now, but you can’t rest on your laurels.”

However, Long added, moves in Congress and in the White House to speed generics to market more quickly could add another strong impetus to future growth among generic suppliers.

Either way, generics are consuming an ever-larger slice of the pharmaceutical drug pie. A little less than half of all prescriptions dispensed now are generics, and that number will inch increasingly closer to 50 percent in the next three years.

There is the prospect that the legislature may enact some form of Medicare prescription benefit by 2004. “A Medicare drug benefit is going to drive [generic] utilization because we know that people who have a drug benefit indeed will use more pharmaceuticals,” commented Joseph Papa, president and chief operating officer of Watson Pharmaceuticals.

“The generic industry sees that as a positive,” commented George Barrett, president and chief executive officer at Teva Pharmaceuticals USA. “Having more consumers with access to medication is important. Any program that’s going to provide any kind of benefit is going to have to utilize generics to keep costs down,” he added.

Also fanning generic prospects are public and private third-party payers, who together now supplement 85 percent to 90 percent of all prescriptions dispensed. Managed care is constantly striving to increase generic utilization as a way to save money. And retail pharmacy is likewise whipping generic utilization up among their patients–generics equal fatter profit margins in a profit-slim business. With managed care and retailers both driving generic utilization, generics claim .an average 78 percent market share within five weeks of being on the market. After 10 weeks, market share climbs to 85 percent, according to research from IMS.

Other factors that could drive generic growth include the Bush administration’s proposal for a $13 million increase in the 2003 budget for the Food and Drug Administration’s Office of Generic Drugs. “President Bush’s proposed budget [will] speed up generic drug reviews,” said Health and Human Services secretary Tommy Thompson last month. If approved by Congress, the FDA will use the additional resources to hire about 40 new experts in generic drugs and related programs.

“If we’re approaching a point in the health care evolution where cost management of high-quality, cost-effective medicine is critical, then we’re [approaching] a peak period where the value that generic drug companies provide should [resonate] throughout the market,” commented Barrett.

Challenges facing industry

The recent uptake in generic fortune does not automatically translate into smooth sailing for the industry, however. “The challenge obviously is the pricing pressure,” remarked Hemant Shah, an independent analyst who has charted the pharmaceutical waters extensively. “This is still

a commodity business, although it’s less of a commodity business than it was five or 10 years ago because there are fewer players, larger players,” he said.

“The industry has matured,” offered David Saks, another independent analyst and pharmaceutical expert. “The exponential high rates of growth year to year are over,” he predicted. Saks argued that the success of Teva, Mylan, Watson and Ivax has made each of these companies so big that they’re brushing up against the same economy-of-scale challenges their larger, branded pharmaceutical cousins face. Many of the branded pharmaceutical businesses have grown so big they have to keep at least five new blockbuster drugs in the hopper in order to realize year-over-year comp growth, Saks said. “One new blockbuster won’t be enough to drive the investment growth rate to attract high demand for their stocks. The same thing goes for the generic industry,” Saks added. There are only so many blockbusters every year that either become open to generic competition or become open to patent-challenging litigation that reaches a generic-friendly conclusion. When the market for those blockbusters drugs becomes open to generic com petition, it quickly matures and just as quickly dissipates, Saks argued.

Blockbusters on the horizon

The winds driving generic sales, i.e. patent expirations, reached gale proportions last year as Prilosec, with $4.6 billion in annual sales; Glucophage, a $2 billion seller; and Prinivil, at $1.1 billion, all lost patent protection. Although there will be fewer billion-dollar blockbusters exposed to generic competition in the next two years, pioneer drugs currently generating almost $11 billion in annual revenues could face generic competition by 2005. In 2006 the winds will reach hurricane proportions again, as a branded business worth more than $9 billion opens to generic competition.

Upcoming billion-dollar patent expirations include Prilosec ($4 billion) in 2003 (presently in courts); Celexa ($1.1 billion) and Cipro ($1.1 billion) in 2004; and Prevacid ($3.2 billion) in 2005. Zocor ($2.7 billion), Zoloft ($2.2 billion) and Pravachol ($1.4 billion) all come off patent in 2006.

However, a combination of branded pharmaceuticals moving to protect their pharmaceutical patents and generic companies challenging those patents in court makes it difficult to mark the proverbial X on a calendar and point to any definitive expiration date. “It has become much more litigation dependent,” Barrett said. “Identifying the peak period is not always something that’s easily done. What we can say is that for the period between now and 2006 [we will see] a very large number of products” become available to generic competition, Barrett said.

The Generic Pharmaceutical Association is already preparing for the day when bio-engineered drugs are opened to generic competition. “The generics industry is poised to open new frontiers for saving consumers money as more and more drug products are derived from or use biotechnology,” remarked Kathleen Jaeger, president and chief executive officer of GPhA. “We will be educating policymakers about the critical role generic biologics can play in the future as the government continues to explore cost-containment measures,” she added.

Increasing numbers of more generic companies are diversifying their product portfolio with branded offerings. “By being so successful [and] so big, [generics] can’t keep staying with the old business plan,” commented Saks. “They need more than just generics [even though] there will be more generics business [in the coming years].”

Top manufacturers by generics sales

2002 $ sales % chg. vs.

in millions prior year

1. Mylan Pharmaceuticals + $1,745.0 18%

2. Teva Pharmaceuticals USA 1,603.5 37

3. Barr Laboratories 1,255.1 60

4. Geneva Pharmaceuticals 1,111.4 18

5. Watson Phrma 1,052.9 24

6. Par Pharmaceutical 884.1 258

7. Bedford/Roxane 478.8 40

8. Abbott Laboratories 475.5 -1

9. Alpharma 434.6 12

10. Ivax Pharmaceuticals 427.1 31

11. Ranbaxy Pharmaceuticals 343.1 121

12. Econ Labs 341.2 65

13. Baxter Pharmaceuticals 314.8 20

14. Warrick Pharmaceuticals 298.8 42

15. Andrx Pharmaceuticals 271.0 556

16. Taro Pharmaceuticals 221.2 79

17. URL/Mutual 204.2 71

18. Apotex 201.2 114

19. American Pharm. Partners 193.1 33

20. Qualitest Products 161.9 44

Total market (branded and generic) $192,256.1 15%

Generic market 14,792.2 37

Source: Drug Store News for the 12 months ended September 2002;

prescription drugs only; includes; insulin; excludes branded generics.

+ Includes unit dose labs.

Top 20 manufacturers by generic prescriptions dispensed

Prescriptions % chg. vs.

dispensed in millions prior year

1. Mylan Pharmaceuticals + 181.4 8%

2. Teva Pharmaceuticals USA 178.6 3

3. Watson Pharma 145.9 1

4. Geneva Pharmaceuticals 119.8 -4

5. Alpharma 76.2 11

6. Ivax Pharmaceuticals 69.7 10

7. Barr Laboratories 59.7 30

8. Mallinckrodt/Tyco Healthcare 42.0 43

9. Qualitest Pharmaceuticals 41.3 21

10. Par Pharmaceutical 40.9 57

11. URL/Mutual Pharmaceutical Co. 39.0 33

12. Warrick Pharmaceuticals 38.7 3

13. Greenstone Limited 32.8 -6

14. Sidmak Laboratories 21.4 0

15. Ranbaxy Pharmaceuticals 16.4 146

16. Taro Pharmaceuticals 15.2 56

17. Ethex Corp. 14.7 12

18. Roxane/Bedford 13.4 4

19. Eon Labs 13.2 43

20. Fougera 11.2 25

Total market

(branded and generic) 3,313.8 5%

Generic market 1,301.8 8

Source: IMS Health for the 12 months ended September 2002; prescription

drugs only: includes insulin; excludes branded generics ** Numbers are

In millions

+ Includes unit dose labs

RELATED ARTICLE: TOP 20 GENERIC PLAYERS by No. of prescriptions dispensed

Mylan Pharmaceuticals

Morgantown, W.Va, (304) 599-2595

No. of generic prescriptions dispensed in 2002: 181.4M

Mylan is a diversified pharmaceutical company with a core generic business that includes solid oral dosage forms, as well as suspensions, liquids, injectables, transdermals and topicals.

Mylan’s 2002 revenues exceeded the billion dollar mark for the first time in the company’s history.

On Nov. 11, the Food and Drug Administration granted Mylan Laboratories the first abbreviated new drug application approval for isotretinoin soft-gelatin capsules. Mylan’s branded subsidiary Bertek Pharmaceuticals will market isotretinoin under the trade name Amnesteem in 10 mg, 20 mg and 40 mg strengths. Amnesteem is bioequivalent and therapeutically equivalent to Roche Laboratories’ Accutane capsules. Accutane, which is prescribed for the treatment of severe recalcitrant nodular acne, currently has annual sales in excess of one-half billion dollars in the United States.

Mylan received ANDA approvals in 2002 for nizatidine capsules, lisinopril and lisinopril/HCTZ, tramadol hydrochloride tablets, levothyroxine sodium tablets, fluoxetine capsules, metformin HCI tablets.

Teva Pharmaceuticals USA

North Wales, Pa., (215) 591-3000

No. of generic prescriptions dispensed in 2002: 178.6M

Teva Pharmaceuticals is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. More than 80 percent of Teva’s sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

In December, the FDA granted tentative approval for Teva’s ANDA for alendronate sodium tablets, the generic equivalent of Merck’s Fosamax tablets for the treatment and prevention of osteoporosis in postmenopausal women and the treatment of Paget’s disease. Fosamax has annual sales of approximately $1.5 billion.

Watson Pharma

Carrollton, Texas, (800) 438-5227

No. of generic prescriptions dispensed in 2002: 145.9M

With about $1.2 billion projected revenue in 2002, Watson has become one of the top pharmaceutical companies by number of generic prescriptions. Watson has achieved No. 1 market share in IV iron and hydrocodone/APAP, and No. 2 market share in oral contraceptives.

Last month, Watson launched two of three oral contraceptives gained through an October 2002 supply arrangement with OMJ Pharmaceutical, an affiliate of Ortho-McNeil Pharmaceutical. MonoNessa (norgestimate and ethinyl estradiol tablets) is Watson’s generic version of Ortho-Cyclen. Necon 7/7/7 (norethindrone and ethinyl estradiol tablets) is Watson’s generic version of Ortho-Novum 717/7. Watson expects approvals in 2003 for Trinessa, its generic version of Ortho Tri-Cyclen, and for the incontinence drug Oxytrol.

Watson’s generic business grew in 2002 with the launches of fluoxetine, metformin, tramadol, lisinopril, buspirone (15 mg), nizatidine, nifedipine and minocycline (75 mg).

Watson expects to file between 10 and 15 ANDAs in 2003.

Geneva Pharmaceuticals

Princeton, N.J., (800) 523-1808

No. of generic prescriptions dispensed in 2002: 119.8M

Geneva, an affiliate of Novartis AG, is one of the largest prescription generic drug companies in the United States. Geneva produces more than 200 products each year, with an annual manufacturing capability exceeding 10 billion tablets and capsules. Geneva products include anti-infectives, anti-arthritics, cardiovasculars, gastrointestinal agents and psychotherapeutics.

In July 2002, Geneva became the first generic company in the United States to launch amoxicillin, clavulanate potassium, the generic form of GlaxoSmithKline’s antibiotic Augmentin.

Last month, Novartis announced its plan to unite its 14 generic company brands, including Geneva, under a single global name, Sandoz, to strengthen recognition and leverage share in the competitive generics marketplace.

Alpharma U.S. Pharmaceuticals

Owings Mills, Md., (800) 638-9096

No. of generic prescriptions dispensed in 2002: 76.2M

Specialty pharmaceutical company Alpharma is the No. 5 manufacturer of generic pharmaceutical products in the United States, offering solid, liquid and topical pharmaceuticals. Alpharma is among the world’s leading producers of pharmaceutical-grade bulk antibiotics.

In 2002, Alpharma’s subsidiary Purepac Pharmaceutical Co. received final approval from the FDA for methylphenidate hydrochloride tablets, the generic equivalent of Ritalin from Novartis Pharmaceuticals for the treatment of attention deficit disorder and narcolepsy. Sales of Ritalin tablets were approximately $48 million in 2001.

Since the beginning of 2002, Alpharma has launched seven products in the United States: fluoxetine (both oral liquid and tablets), metformin tablets, diclofenac ER tablets, tramadol tablets, lisinopril/hydrochlorothiazide tablets and tizanidine tablets. Year-to-date 2002, the company has received eight FDA approvals and has pending ANDAs targeting approximately $5billion of brand sales.

Alpharma expects revenues to increase 8 percent to 10 percent in 2003 to about $1.35 billion this year.

Ivax Pharmaceuticals

Miami, (800) 327-4114

No. of generic prescriptions dispensed in 2002: 69.7M

In 2002, Ivax received final FDA approval to market generic versions of Eli Lilly’s Prozac and Bristol-Myers Squibb’s Glucophage tablets. Last year’s U.S. sales of branded and generic fluoxetine hydrochloride were more than $2.5 billion. U.S. sales of Glucophage tablets were approximately $1.8 billion.

In March, Ivax acquired from Roche Group the branded intranasal steroid formulations of flunisolide hemihydrate for the treatment of seasonal and perennial allergic rhinitis.

The ANDA for the generic drug tramadol hydrochloride tablets in 50 mg strength has been transferred to Ivax from Able Laboratories. Ivax will purchase the product exclusively from Able Laboratories and market the tramadol hydrochloride tablets under its own label.

Barr Laboratories

Pomona, N.Y., (845) 362-1100

No. of generic prescriptions dispensed in 2002: 59.7M

Barr Laboratories’ generic business is focused on female health care, anti-infectives and antibiotics, psychotherapeutic treatments, pain management and treatments for cancer and heart disease.

Barr is among the largest developers, manufacturers and marketers of oral contraceptives in the U.S. In April 2002, Barr added to its portfolio two oral contraceptives: Kariva, the generic version of Organon’s Mircette, and Lessina, the generic version of Berlex Laboratories’ Levlite.

In June 2002, Barr launched two additional oral contraceptive products: Enpresse, the generic version of Wyeth’s Triphasil tablets and Berlex’s Tri-Levien tablets, and Portia, the generic version of Monarch Pharmaceuticals’ Nordette.

Barr launched its ninth oral contraceptive, Cryselle tablets, the generic version of Wyeth’s Lo/Ovral, in July.

In September, Barr received final approval for a generic version of Ortho-Novum 7/7/7 and was set to launch its generic version of Nortrel 7/7/7 last month.

Mallinckrodt/Tyco Healthcare

Hazelwood, Mo., (314) 654-2000

No. of generic prescriptions dispensed in 2002: 42.0M

Mallinckrodt, a business of Tyco Healthcare based in St. Louis, is a global manufacturer and marketer of health care products in respiratory care, diagnostic imaging and analgesics. The respiratory group is a worldwide leader in respiratory devices and airway management systems. The imaging group provides devices and products for magnetic resonance, nuclear medicine, ultrasound and X-ray. The pharmaceuticals group produces bulk and dosage pharmaceuticals for pain relief and addiction therapy. Mallinckrodt has worked to supplant its bulk and laboratory chemical business to include the manufacturing and distribution of pharmaceutical dosage products.

In 2002, Mallinckrodt received approvals for dextroamphetamine sulfate tablets, hydrocodone bitartrate and acetaminophen oral solution and tablets, naltrexone hydrochloride tabblets, fluoxetine capsules an oral solution, tramadol hydrochloride tablets and Cysto-Conray & Cysto-Conray II (iothalamate meglumine 43% and 17.2%) injection.

Qualitest Pharmaceuticals

Huntsville, Ala., (256) 859-4011

No. of generic prescriptions dispensed in 2002: 41.3M

In 2002, Qualitest expanded its capacity when it opened a new 315,000-square-foot pill and capsule facility in Huntsville, Ala. Qualitest, which offers about 300 products under 500 SKUs, has had good success with its hydrocodone/APAP pain product. Even with Qualitest’s growing size, its sales reps still call on individual pharmacies.

Par Pharmaceutical

Spring Valley, N.Y., (845) 425-7100

No. of generic prescriptions dispensed in 2002: 40.9M

The product line of Par Pharmaceuticals, a subsidiary of Pharmaceutical Resources, consists of prescription and over-the-counter products. Some of Par’s products awaiting approval may garner first-to-file opportunities to receive up to 180 days of marketing exclusivity. These products include omeprazole (Prilosec), paroxetine capsules (Paxil), olanzapine 20 mg (Zyprexa), latanoprost (Xalatan), ribavirin (Rebetol) and tramadol with acetaminophen (Ultracet). Total sales of the branded equivalents of these six products are approximately $8 billion.

Recent product launches include: flecainide acetate, the generic version of Tambocor; tizanidine, the generic form of Zanaflex; nizatidine, the generic version of Axid; and lisinopril, the generic equivalent of Zestril.

Rapid sales growth throughout Par’s base business reduced the company’s reliance on such products as megestrol and fluoxetine, which through the first six months of 2002 represented approximately 55 percent of Pharmaceutical Resources total revenues. But by third quarter 2002, their contribution was 33 percent of revenues.

URI/Mutual Pharmaceutical Philadelphia, (215) 288-6500 No. of generic prescriptions dispensed in 2002: 39.03M

United Research Laboratories/Mutual Pharmaceutical specializes in the application of proprietary drug delivery and stabilization technologies to formulate and commercialize difficult-to-formulate drug products.

In 2002, URL/Mutual had its most successful year, with sales in excess of $290 million. The company filed 10 ANDAs, including the first Paragraph IV filings for felodipine ER tablets (Plendil ER, AstraZeneca). URLIMutual’s launch of felodipme ER tablets is pending successful resolution of patent issues currently under litigation. Upon settlement of those patent issues and FDA approval, URL/Mutual expects a minimum of six months exclusivity to market the product.

URL/Mutual received approval for seven ANDAs during 2002, including propafenone, AB-rated to Knoll’s Rhythmol; bisoprolol fumarate, AB-rated to Lederle’s Zebeta; fluoxetine HCI, AB-rated to Lilly’s Prozac; diclofenac potassium, AB-rated to Novartis’ Cataflam; fluvoxamine maleate, AB-rated to Solvay’s Luvox; metformin HCI, AB-rated to BristolMyers Squibb’s Glucophage; and Tramadol HCI, AB-rated to R.W. Johnson and Co.’s Ultram.

Warrick Pharmaceuticals

Union, N.J., (908) 629-3601

No. of generic prescriptions dispensed in 2002: 38.7M

Warrick Pharmaceuticals is the generic pharmaceutical marketing subsidiary of ScheringPlough. Warrick markets albuterol sulfate, augmented betamethasone dipropionate ointment, clotrimazole and betamethasone cream, isosorbide mononitrate ER tablets, sodium chloride solution 0.9% and sucralfate tablets.

Greenstone

Peapack, N.J., (800) 435-7095

No. of generic prescriptions dispensed in 2002: 32.8M

Greenstone, founded in 1993, is a wholly owned subsidiary of Pharmacia Corp. It focuses on the life-cycle management of branded products that have lost exclusivity and are subject to generic competition. In addition to generating sales, Greenstone provides value to its parent company by minimizing manufacturing decline of branded products and minimizing reallocation of unused capacity. Greenstone endeavors to maintain an excellent reputation within its customer base, selling products in the United States and Puerto Rico markets.

Sidmak Laboratories

East Hanover, N.J., (973) 386-5566

No. of generic prescriptions dispensed in 2002: 21.4M

Croatian pharmaceutical giant Pliva gained a toehold in the U.S. market last year with its acquisition of East Hanover, N.J.-based Sidmak Laboratories and its subsidiary Odyssey Pharmaceuticals in a deal worth a total of $211.9 million between cash considerations and debt assumptions. Two products from Sidmak’s portfolio, hydroxyzine hydrochloride and urecholine, ranked among Pliva’s top 10 pharmacy offerings by third quarter 2002.

Just last month, Sidmak announced it would take on its parent company’s name, effective next month, creating name awareness for Pliva in the U.S. generics market.

The company launched four generic products last year through Sidmak, those being cyclosporin solution, ethosuximide, fluoxetine and tramadol. In addition, Sidmak/Pliva made 10 ANDA filings last year and expect to make an additional 10 to 12 ANDA filings in 2003.

“We expect that the U.S. will become Pliva’s largest market in 2003 in terms of sales of finished prescribed pharmaceuticals,” the company predicted.

Ranbaxy Pharmaceuticals

Princeton, N.J., (609) 720-9200

No. of generic prescriptions dispensed in 2002: 16.4M

Ranbaxy Laboratories, India’s largest pharmaceutical company and the 11th largest generic company worldwide, manufactures and markets branded and generic pharmaceuticals and active pharmaceutical ingredients, with a therapeutic focus on antiinfectives, urology, cancer, CNS, CVS, diabetes and dyslipidemia.

Ranbaxy has filed two NDAs in the United States for metformin and ofloxacin. During 2002, Ranbaxy filed 23 ANDAs (surpassing its target of 15 to 20 ANDA filings annually) and received 11 approvals, taking the cumulative number of approvals to 58 with 37 pending approvals.

In December 2002, the FDA approved Bayer’s anti-bacterial product CiproXR (ciprofloxacin extended-release tablets) developed in collaboration with Ranbaxy in a dosage strength of 500 mg for treatment of uncomplicated urinary tract infections. Ranbaxy will receive royalties from sales of Cipro XR 500 mg tablets.

In 2002, the FDA also approved Ranbaxy’s versions of amoxicillin for oral suspension, isotretinoin capsules and coamoxyclav tablets.

Taro Pharmaceuticals USA

Hawthorne, N.Y., (914) 345-9001

No. of generic prescriptions dispensed in 2002: 15.2M

Taro is a leader in U.S. markets for topical corticosteroids and antifungal medications, including both prescription and over-the-counter drugs.

Three of Taro’s 2002 FDA approvals were for conditions affecting the skin: ketoconazole cream and econazole nitrate cream, both for the treatment of fungal infections of the skin; and amcinonide cream for the treatment of inflammatory skin conditions.

Taro’s other approvals in 2002 were for amiodarone tablets for treating atrial fibrillation and other cardiovascular conditions, and teril carbamazepine tablets, an anticonvulsant.

Taro has 16 ANDAs on file with the FDA. In June, Taro received tentative approval from the FDA for its ANDA for loratadine syrup 10 mg/10 ml, bioequivalent to Schering-Plough’s Claritin syrup.

Ethex

Maryland Heights, Mo.

(314) 567-3307

No. of generic prescriptions dispensed in 2002: 14.7M

Ethex Corp., a subsidiary of KV Pharmaceutical Co., has been focusing on products for cardiovascular disease, women’s’ health, pain management and cough/cold. Ethex’s current product line includes more than 80 products, of which approximately 58 percent are identified by MS America as the leading product in their respective generic categories. Ethex’s net sales have grown at a compound annual rate of 28 percent from 1995 to 2002.

Since Jan. 1, 2002, Ethex has received five ANDA approvals from the FDA for generic equivalents to Rythmol, Buspar, Lortab Elixir, K-Dur and Prelone.

Last month, KV and Ethex launched the first product utilizing KV’s OraQuick quick-dissolving tablet technology, hyoscyamine sulfate orally disintegrating tablets, 0.125 mg, a prescription anticholinergic/antispasmodic.

Roxane Laboratories

Columbus, Ohio, (800) 962-8364

No. of generic prescriptions dispensed in 2002: 13.4M

Roxane Laboratories, a subsidiary of Boehringer Ingelheim, specializes in oral anti-cancer therapies, sterile respiratory therapies and the development and marketing of multisource generic products.

Roxane began developing, manufacturing and marketing unit dose liquid medications to hospitals when unit dose dispensing was a new concept in drug distribution, but is now the standard.

Roxane received FDA approvals in 2002 for butorphanol tartrate nasal spray, flecainide acetate tablets, ipratropium bromide inhalation solution, megestrol acetate oral suspension and midazolam hydrochloride syrup.

Roxane also received tentative FDA approvals in 2002 for tobramycin solution for inhalation, nefazodone hydrochloride tablets, tobramycin solution for inhalation and mirtazapine tablets.

Eon Labs

Laurelton, N.Y., (718) 276-8600

No. of generic prescriptions dispensed in 2002: 13.2M

Eon Labs is a generic pharmaceutical company specializing in developing, licensing, manufacturing, selling and distributing a broad range of prescription pharmaceutical products. Eon’s product line includes more than 90 generic pharmaceutical products.

Eon’s list of ’02 approvals includes omeprazole 10 mg and 20 mg delayed-release capsules, the generic alternative for Prilosec; tizanidine HCI, 2 mg tablets, the generic alternative for the spasticity treatment Zanaflex; the 5 mg strength of the generic alternative for Adderall used in the treatment of ADHD; and etodolac, extended-release tablets, the generic alternative for the osteoarthritis and rheumatoid arthritis treatment Lodine XL.

Eon was first-to-market with the approval of nizatidine capsules, the generic alternative for the active duodenal ulcer treatment.

The approval of Lisinopril tablets, the generic version of Zestril, is the 10th approval for Eon Labs in 2002.

E. Fougera & Co.

Melville, N.Y., (631) 454-6996

No. of generic prescriptions dispensed in 2002: 11.2M

Fougera started out in Brooklyn in 1849. Founder Edmond Fougera imported French remedies from his home country, not only to stock his own apothecary, but for distribution to other local pharmacies, as well. By 1918, Fougera was the largest pharmaceutical importer into the United States.

More than 150 years later, Fougera is still serving the pharmacy community, now specializing in topical and ophthalmic generic drugs.

Now owned by the German pharmaceutical company Altana, Fougera last month announced an FDA tentative approval for its betamethasone dipropionate cream, a topical steroid. The product compares to Schering’s Diprolene, which comes off patent in December. In 2002, Fougera had a total of eight first approvals, a record for a generic topical company, Fougera reported. For example, Fougera secured first generic approval of econazole nitrate cream last November. Compared with Ortho Dermatological’s Spectazole, the cream is indicated against athlete’s foot, jock itch and ringworm.

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