Indian Firms Get Approval for Generics of AstraZeneca Drug

  • Aurobindo, Glenmark say they received approval to sell in U.S.
  • Both stocks climb on entry into $7 million a day market

Indian drugmakers won U.S. approval to sell generic versions of the cholesterol pill Crestor, gaining permission to sell cheaper copies of an AstraZeneca Plc best-selling pill that brings in $7 million in U.S. sales every day.

India’s Aurobindo Pharma Ltd., Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Ltd. received approval from the U.S. Food and Drug Administration to sell the generics, according to stock exchange statements from the companies on Wednesday.

A federal judge in Washington, D.C., ruled against AstraZeneca’s request for a temporary ban on generic versions of the medicine on Tuesday. That means the $5 billion AstraZeneca saw in sales from Crestor last year could plunge to $3.5 billion this year as cheaper alternatives become available, according to analyst estimates compiled by Bloomberg.

Aurobindo said in a statement that its successful application makes it eligible for 180 days of "shared exclusivity" selling the drug. The first copycat version of Crestor is already on the market from Allergan Plc’s Watson Pharmaceuticals after a settlement in a patent infringement suit gave the manufacturer sole rights to start selling its version in early May.

"This is a good approval but it all depends on how many others get approval," said Surajit Pal, an analyst covering Indian pharmaceutical stocks at Prabhudas Lilladher Pvt. in Mumbai, adding there will be at least four generic versions in the first wave of approvals though the general expectation is for six to share exclusive rights to sell the drug in the U.S. for the next 180 days.

For AstraZeneca, the challenge to Crestor comes as the London-based company has seen a sharp drop in sales from the highs of 2011 because of patents expirations on top drugs. In Mumbai, Aurobindo shares were up as much as 4.3 percent, Glenmark rose as much as 3.1 percent and Sun Pharma added as much as 1.5 percent. AstraZeneca rose 0.6 percent to 4,560 pence at 8:04 a.m. in London trading.

Calls to AstraZeneca’s media line were unanswered. Other Indian firms with tentative approvals for generic Crestor are Torrent Pharmaceuticals Ltd. and Alkem Laboratories Ltd. Queries asking whether these companies have also received final approvals via e-mail and telephone were not immediately returned.

Outside of India, Apotex Corp., Mylan NV, Teva Pharmaceutical Industries Ltd., Endo International Plc-owned Par Pharmaceutical, and Sandoz AG all have applications for approval too, according to FDA data.

Before it's here, it's on the Bloomberg Terminal. LEARN MORE