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Branded drugs” domination of a market slips away with each generic launch. “Global sales of generic drugs will grow more than 20 percent annually to reach $80 billion by 2008, as healthcare providers turn increasingly to less-expensive, unpatented medicines,” said Graham Lewis, IMS vice president for pharma strategy.
The big blockbuster generic drugs to be approved this year were zolpidem tartrate (Ambien), as well as amlodipine and benazepril (Lotrel) and metoprolol succinate extended-release (Toprol XL). These brand-name drugs had a combined selling of almost $5 billion in the United States last year.
Sanofi-Aventis’ Ambien was the biggest money-maker to lose its patent, after grossing $2.2 billion in sales last year. The sleep aid was approved in 13 generic equivalents within two days by the Food and Drug Administration to such companies as Mylan, Dr. Reddy’s, Watson and Prasco, which released an authorized generic.
The high blood pressure medications Toprol XL and Lotrel were released as generics more recently, and their manufacturers were granted an 180-day exclusivity period on the market.
AstraZeneca’s Toprol XL already saw its 25 mg launched as a generic last year by Par Pharmaceuticals. Now all strengths of the drug are available in generic versions. The 100 mg and 200 mg strengths were released a week before the 50 mg by KV Pharmaceuticals, which was then followed by Sandoz’ 50 mg tablet. Toprol XL accounted for more than 40 million prescriptions dispensed last year in the United States.
Novartis’ Lotrel was approved in generic forms in the dosages of 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg to Teva Pharmaceuticals. The 5 mg/40 mg and 10 mg/40 mg strengths are still only available in the branded form.
Once these 180-day periods expire, these companies will see a lot of competition just like generic Norvasc (amlodipine besylate) saw when Mylan’s exclusivity expired and competition quickly sprang up from such drug manufacturers as Ranbaxy, Teva and Roxane Laboratories.
Recently, news broke of Ranbaxy’s decision not to sell a generic version of the drug Clarinex until the U.S. patent expires on the Schering-Plough drug in 2020. This came after a judge’s decision in a U.S. District Court in New Jersey to block the company from manufacturing or selling a generic version of the allergy medication. Even though sales were disappointing in 2006, the drug still made $722 million.
Pfizer’s antihistamine drug Zyrtec loses its patent in December. The FDA has granted tentative approval to an application from Caraco for cetirizine hydrochloride, 5 mg and 10 mg immediate-release tablets. Zyrtec had U.S. sales of more than $1 billion for the 12-month period ended Dec. 31, 2006, according to IMS data.
On June 29, the FDA approved generic formulations of GlaxoSmithKline’s Paxil CR in 12.5 mg and 25 mg. This is the first approved generic version of the psychotropic drug, which will be manufactured by Mylan.
GlaxoSmithKline’s Coreg, which is used for treatment of high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack, was just approved for a generic version (carvedilol) in all strengths. The companies that were granted approval were Sandoz, Apotex, Dr. Reddy’s, Taro, Zydus, Ranbaxy, Teva, Mylan, Watson, Lupin, Glenmark, Aurobindo, Caraco and Actavis. Actavis chief executive officer Robert Wessman called the approval, a “recognition of our expanded pipeline,” which also recently introduced generic versions of Norvasc and the pain patch Duragesic. Annual sales of Coreg were approximately $1.7 billion in the United States for the 12-month period ended June 30, according to IMS Health.
Another approval this year was awarded for generic Lamisil tablets (terbinafine hydrochloride). The FDA approved products from companies including Apotex, Aurobindo, Dr. Reddy’s, Glenmark and Wockhardt. This antifungal medication from Novartis saw annual U.S. sales of approximately $687 million for the 12 months ended March 2007, according to IMS Health data.
Migraine medication Imitrex from GSK lost its patent in June. GSK has granted Dr. Reddy’s authorized generic status for sumatriptan succihate, which is expected to launch at the end of next year.
Next year will only be bigger for generics as more big name drugs lose their patents. Some of the big names that will lose their protection are Effexor XR (Wyeth), Fosamax (Merck), Depakote (Abbott), Advair (GSK), Topamax (Ortho-McNeil), and Lamictal (GSK). Risperdal (Janssen) is set to lose its patent on Dec. 29, but because of their pediatric extension, Janssen will hold marketing rights until June 29, 2008.
Pharmaceutical product growth by dollars and prescriptions
dispensed

Dollars U.S. $ *

clopidogrel Apotex $1,125
simvastatin Teva 1,072
Lucentis Genentech 842
Vytorin Merck & SP 781
Cymbalta Lilly 697
Avastin Genentech 676
sertraline hcl Pfizer 651
Gardasil Merck 621
Atripla BMS/Gilead 602
Aranesp Amgen 584

No. of
Rx dispensed Rxs *

simvastatin Teva 19.9
levothyroxine Mylan 17.4
lisinopril Lupin 15.0
sertraline hcl Pfizer 14.0
azithromycin Pfizer 13.0
sertraline hcl Teva 11.3
HYCD/APAP Watson 11.3
clopidogrel Apotex 10.3
simvastatin Dr. Reddy’s 10.2
SMX/TMP Lannett 8.4

* in millions

Source: IMS Health, National Sales Perspectives, National
Prescription Audit Plus, MAT June 2007

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