Lopressor

Teva Pharmaceuticals USA

www.tevapharm.com

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

No. of generic prescriptions dispensed in 2003: 202.5M

Israel-based Teva Pharmaceuticals is the largest generic drug maker in the world--No. 30 among all pharmaceutical companies. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Almost 90 percent of the company's sales are in North America and Europe.

In January, Teva acquired Sicor, a multinational pharmaceutical company that focuses on generic finished-dosage injectables, active pharmaceutical ingredients and generic biopharmaceuticals.

The generic drug maker also entered a strategic collaboration with Andrx Corp. to develop and market oral contraceptives. The alliance gives Teva exclusive marketing rights to Previfem (norgestimate and ethinyl estradiol), the newly approved abbreviated new drug application and bioequivalent of Ortho Cyclen-28, an Ortho McNeil Pharmaceutical oral contraceptive product. Teva also has marketing rights to Andrx's entire line of generic oral contraceptives currently awaiting Food and Drug Administration approval.

In December, Teva received tentative FDA approval for terbinafine hydrochloride tablets, the generic equivalent to Novartis' antifungal agent Lamisil, with annual sales of about $541 million.

Other notable happenings in 2003 include final FDA approval for fosinopril sodium tablets, the bioequivalent of Bristol-Myers Squibb's Monopril tablets for treating hypertension and managing of congestive heart failure. Annual sales of Monopril through June 2003 were $267 million.

Mylan Pharmaceuticals

www.mylan.com

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

No. of generic prescriptions dispensed in 2003: 189.7M

Mylan Laboratories develops, manufactures and markets an extensive line of generic and proprietary prescription drugs. The generic segment consists of two principal business units, Mylan Pharmaceuticals and UDL Laboratories, both wholly owned subsidiaries. Mylan's generic product portfolio includes immediate- and extended-release oral tablets, capsules and transdermal patches.

Last month, the FDA approved Mylan's ANDA for a 25 mg dosage of metoprolol tartrate, a generic version of Novartis AG's blood pressure drug, Lopressor. Mylan already sells the drug in 50 mg and 100 mg doses.

In December, the FDA granted Mylan final approval for metolazone tablets, the generic version of Celltech Pharmaceuticals' branded diuretic, Zaroxolyn. Also in December, the FDA granted Mylan tentative approval for levofloxacin tablets, the generic version of Ortho McNeil Pharmaceutical's Levaquin tablets in a class of antibiotics called fluoroquinolones.

In the last half of 2003, Mylan received FDA approval for its fentanyl transdermal system, the generic version of Alza Corp.'s pain patch, Duragesic, with sales in excess of $1 billion for the 12 months ended in June. Mylan also received ANDA approvals for nefazodone hydrochloride tablets, the generic version of Bristol-Myers Squibb's depression drug, Serzone, and for 10 mg and 20 mg omeprazole delayed-release capsules, the generic version of AstraZeneca LP's heartburn medication, Prilosec.

Watson Pharma

www.watsonpharm.com

Corona, Calif., (909) 493-5300

No. of generic prescriptions dispensed in 2003: 140.7M

Watson is the fifth-largest U.S. pharmaceutical company in terms of prescriptions dispensed, numbering 173 million in 2003. In 2002, its revenue mix was 45 percent generic and 55 percent branded. The company launched 16 generic drugs on the market in 2003.

Last month, under a supply agreement with GlaxoSmithKline, Watson began shipping bupropion hydrochloride sustained-release tablets, the generic version of GSK's Wellbutrin SR for treating depression. For the 12 months ended in November, Wellbutrin SR had sales of about $300 million.

In 2003, Watson announced that it would expand its generic product development by forming an alliance with Cipla Ltd., the second-largest pharmaceutical company in India. Under the agreement, Cipla will manufacture generic drugs, and Watson will have exclusive U.S. marketing rights.

Watson's notable genetic approvals in 2003 include glipizide extended-release tablets, the generic equivalent of Pfizer's Glucotrol XL for treating type 2 diabetes. For the 12 months ended in September, Glucotrol XL had sales of about $345 million. Watson also launched oxycodone/APAP, the generic equivalent to Endo Pharmaceuticals' Percocet tablets for moderate to moderately severe pain. For the 12 months ended in August, Percocet had sales of about $157 million.

Sandoz

www.us.sandoz.com

Princeton, N.J.,

(609) 627-8500

No. of generic prescriptions dispensed in 2003: 129.1M

In December, Geneva Pharmaceuticals, a Novartis-owned company, announced it would conduct all business operations under the name Sandoz. The move united 14 different generic drug units under one common name. Today, Sandoz manufactures more than 200 generic pharmaceutical products in more than 500 package sizes.

Sandoz's U.S. retail pharmaceuticals business and the integration of Slovenian pharmaceutical company Lek drove its full-year sales. The company posted strong sales growth in fourth quarter 2003, despite intense competition for AmoxC, the company's generic version of GlaxoSmithKline's antibiotic, Augmentin. In 2003, Sandoz also acquired Amifarma in Spain, strengthening its antibiotics production capacity and technology.

Sandoz files about 800 submissions annually for new products in close to 100 countries worldwide. The generic drug maker focuses primarily on product groups that include anti-infectives, anti-arthritics, cardiovascular drugs, gastrointestinal agents and psychotherapeutics.

Last year marked a record year for Sandoz, which had sales of $2.9 billion and an operating income of $473 million.

Alpharma

www.alpharma.com

Fort Lee, N.J.

(201) 947-7774

No. of generic prescriptions dispensed in 2003: 71.2M

Alpharma is the largest manufacturer of generic liquid and topical pharmaceuticals in the United States and is one of the largest suppliers of generic pharmaceuticals in select European markets. It also is one of the largest manufacturers of generic solid-dose pharmaceuticals in Europe, with a growing presence in Southeast Asia.

Last month, the company launched clotrimazole and betamethasone dipropionate topical cream, the generic equivalent of Schering-Plough Corp.'s Lotrisone for treating dermal infections.

The company last month also reached an agreement with generic drug maker Ivax Corp. regarding its metformin hydrochloride tablets, the generic form of Glucophage XR tablets marketed by Bristol-Myers Squibb Co. Glucophage XR, indicated for type 2 diabetes, posts brand sales of about $450 million annually. Alpharma and Ivax now will share profits on an equal basis on all sales during a 180-day exclusivity period for the generic version.

Alpharma also announced that Purepac Pharmaceutical Co., a wholly owned subsidiary, is the sole entity entitled to a 180-day marketing exclusivity period for gabapentin capsules, the generic equivalent of Pfizer-marketed Neurontin tablets and capsules. Neurontin has annual brand sales of more than $2 billion and is indicated as adjunctive therapy for treating epilepsy and post-herpetic neuralgia.

Ivax

www.ivax.com

Miami, Fla.,

(305) 575-6000

No. of generic prescriptions dispensed in 2003: 69.6M

Ivax is a multinational pharmaceutical corporation dedicated to the research, development, manufacturing, marketing and distribution of branded and generic drugs.

In December, the company entered an agreement with Hungary-based Gedeon Richter Ltd., under which a number of genetic drugs will be developed for the U.S. market and distributed by Ivax.

Also in December, the company began distributing its oral antibacterial combination amoxicillin with clavulanate potassium. The drug is the generic equivalent of Augmentin, marketed by GlaxoSmithKline, with U.S. sales of $1.4 billion for the 12 months ended Sept. 30.

In late 2003, Ivax received tentative FDA approval for its ANDA for gabapentin capsules, the generic equivalent of Pfizer's anti-epileptic drug, Neurontin.

Mallinckrodt/Tyco

www.mallinckrodt.com

Hazelwood, Mo.,

(314) 654-2000

No. of generic prescriptions dispensed in 2003: 63.4M

Mallinckrodt is a global manufacturer and distributor of specialty medical products that sustain breathing, help diagnose diseases and relieve pain. The company is also the world's leader in bulk analgesic pharmaceuticals.

Mallinckrodt received FDA approval in August to market morphine sulfate extended-release tablets. The tablets are indicated for treating moderate-to-severe pain and are available in five strengths ranging from 15 mg to 200 mg. The approval made Mallinckrodt the first drug maker to bring a complete line of genetic morphine sulfate extended-release tablets to market.

Sales of the genetic pain relievers, all bio-equivalent to Purdue Frederick's brand name product MS Contin, surpassed sales of MS Contin for the first time in 2002.

Qualitest Pharmaceuticals

Huntsville, Ala.,

(256) 859-4011

No. of generic prescriptions dispensed in 2003: 57.8M

The eighth-largest generic drug maker by total prescriptions dispensed is privately held Qualitest Pharmaceuticals. The company dispensed more than 57 million prescriptions in 2003. Company officials were not available for further comment on 2003 sales or newly approved ANDAs.

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

Par Pharmaceutical

www.parpharm.com/

Spring Valley, N.Y.,

(845) 425-7100

No. of generic prescriptions dispensed in 2003: 53.7M

Par Pharmaceutical, a wholly owned subsidiary of Pharmaceutical Resources, manufactures and distributes a broad line of generic drugs. The company reported its total revenues increased 116 percent to $216.6 million for the third quarter ended in September.

Its launch of paroxetine hydrochloride immediate-release tablets, the generic version of GlaxoSmithKline's branded antidepressant drug, Paxil, powered strong 2003 sales.

At the end of 2003, Par had 23 drugs awaiting FDA approval and more than 40 in development. Par believes several of its drugs may represent first-to-file opportunities entitling the company to 180 days of marketing exclusivity. Those ANDA fillings include olanzapine, a generic for Zyprexa; latanoprost, a generic for Xalatan; ribavirin, a generic for Rebetol; tramadol with acetaminophen, a generic for Ultracet; and testosterone gel 1%, a generic for Androgel.

Barr Laboratories

www.barrlabs.com

Pomona, N.Y.,

(845) 362-1100

No. of generic prescriptions dispensed in 2003: 52.5M

Barr Laboratories is a specialty pharmaceutical company engaged in developing, manufacturing and marketing generic and proprietary pharmaceuticals. It manufactures and distributes more than 100 pharmaceutical products in core therapeutic categories including oncology, female health care, cardiovascular, anti-infectives and psychotherapeutics. The company realized fiscal 2003 revenues of $903 million.

Barr launched its 15th generic oral contraceptive in September 2003. Last month, it received tentative FDA approval for its generic version of Cephalon's Provigil (modafinil), indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. It also received tentative FDA approval for its generic version of Ortho-McNeil's antiepilepsy drug, Topamax (topiramate).

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