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Aerobid

Flunisolide (AerobidĀ®) is a corticosteroid often prescribed as treatment for allergic rhinitis.

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10 manufacturers to watch - Generic Drugs
From Drug Store News, 2/16/04

Inwood Laboratories

Inwood, N.Y.,

(718) 471-8000

Inwood Laboratories is the generics subsidiary of Forest Laboratories, a company named by Fortune magazine as one of the 100 fastest-growing companies for four years running and the fastest-growing company in 2003. Forest has a strong portfolio and growing product line, including such drugs as Lexapro, a selective serotonin reuptake inhibitor antidepressant indicated for generalized anxiety disorder; Celexa, also an antidepressant; Namenda, for treating moderate-to-severe Alzheimer's disease; Tiazac, a once-daily diltiazem for treating angina and hypertension; Benicar, for treating hypertension; and Aerobid, an inhaled steroid for treating asthma.

Hi-Tech Pharmacal

www.hitechpharm.com

Amityville, N.Y.,

(631) 789-8228

Generic sales for retail in the first half of 2003: $23M

Hi-Tech Pharmacal manufactures liquid and semi-solid dosage pharmaceutical products, with generics generating nearly 80 percent of its revenues. The company stated that more than $1 billion worth of branded liquid and semi-solid pharmaceuticals will be coming off patent in the next five years, including solutions for oral, otic and ophthalmic use, inhalation, suspensions, nasal sprays, creams and ointments.

For the quarter ended Oct. 31, net sales of Hi-Tech's generic pharmaceutical products were $13.9 million, a 41 percent increase compared with $9.9 million for the same period in 2002. The increase is attributed to the October introduction of urea 40% cream and lotion, accounting for $3.4 million in sales.

URL/Mutual Pharmaceutical

www.urlmutual.com

Philadelphia, (215) 288-6500

No. of generic prescriptions dispensed in 2003: 40.6M

Privately held United Research Laboratories/Mutual Pharmaceutical Co. invests more than 20 percent of its revenues into research and development programs.

The company is engaged in the application of proprietary drug delivery and stabilization technologies to develop and commercialize difficult-to-formulate drug products. It currently works with branded pharmaceutical companies on the application of its proprietary technologies for product development and commercialization, including the in-licensed technology applicable to improving bioavailability of New Chemical Entities.

Company projections based on performance through July and exclusive of any ANDA approvals or court decisions indicated URL/Mutual would reach 2003 sales exceeding $360 million, an increase of 25 percent over record 2002 sales.

Eon Labs

www.eonlabs.com

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

No. of generic prescriptions dispensed in 2003 (retail only): 19M

Eon Labs' product line consists of about 117 products representing various dosage strengths for 55 drugs. Almost two-thirds of Eon's products rank first or second in market share.

The generic drug maker launched its bupropion HC1 tablets, the generic equivalent of GlaxoSmithKline's depression drug, Wellbutrin SR, last month. Eon expected to report net sales and diluted earnings per share for fourth quarter 2003 of $85 million to $90 million, or $0.38 to $0.41 per share, respectively, compared with previously issued guidance for net sales and diluted earnings per share of $75 million to $80 million, or $0.33 to $0.36 per share.

Xttrium Laboratories

www.xttrium.com

Chicago, (773) 268-5800

U.S. generic sales in 2003: $12M

Xttrium is the largest U.S. supplier of FDA-approved 2 percent and 4 percent CHG formulations, the most effective known antimicrobial for surgical scrubbing and health care personnel hand washing. Xttrium also is the leading U.S. supplier of the antimicrobial agent 20% BP chlorhexidine gluconate.

Warrick Pharmaceuticals

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

Warrick Pharmaceuticals is the generic subsidiary of Schering-Plough. The generic drug arm markets albuterol sulfate, augmented betamethasone dipropionate ointment, clotrimazole and betamethasone cream, isosorbide monoitrate ER tablets, sodium chloride solution 0.9% and sucralfate tablets.

Ranbaxy Pharmaceuticals

www.ranbaxy.com

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

U.S. generic sales in 2003: $355M

Ranbaxy Laboratories, India's largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and active pharmaceutical ingredients in more than 70 countries.

In the United States, Ranbaxy received 21 ANDA approvals and its first new drug application approval in 2003, taking its cumulative number of approvals as of January to 81, with 40 products currently pending approval. Last year, Ranbaxy filed 26 ANDAs with the FDA, surpassing its target of 15 to 20.

For the year ended Dec. 31, Ranbaxy recorded net global sales of $969 million, an increase of 27 percent from 2002. U.S. revenues totaled $411 million, a 39 percent growth over 2002.

Taro Pharmaceuticals USA

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

U.S. sales for the 12 months ended

Sept. 30: $251M

Taro Pharmaceutical Industries is a multinational pharmaceutical company. Its prescription and over-the-counter medications are used primarily in dermatology, pediatrics, cardiology and neurology. The company produces more than 200 pharmaceutical products, including topical preparations, oral medications and sterile products.

Currently, Taro has 31 ANDA filings with the FDA, including two tentative approvals and two unique supplemental ANDAs. The company also has an NDA related to its NonSpil liquid drug delivery system.

In December, the company received approvals for its ANDAs for the topical corticosteroids betamethasone dipropionate cream and betamethasone dipropionate gel, the bioequivalents to Schering-Plough's Diprolene AF cream and Diprolene gel.

E. Fougera & Co.

www.fougera.com

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

Fougera, a division of Altana, is a specialty pharmaceutical manufacturer of topical steroids, antibiotics, antifungal products and ophthalmics in both prescription and over-the-counter dosage forms.

In August, the company was the first to receive ANDA approval for topical anesthetic lidocaine and prilocaine cream, the bioequivalent to Emla, AstraZeneca which manufactures. In 2002, the company reported it received more topical generic FDA approvals than any other drug maker during the last five years.

Fougera received eight first approvals in 2002 and received five first approvals in 2003.

COPYRIGHT 2004 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2004 Gale Group

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