Teva Pravachol Exclusivity Loss Raises Bristol’s Stakes For Switch

Bristol-Myers Squibb has more to gain from an Rx-to-OTC switch of the cholesterol-lowering drug Pravachol (pravastatin) if an FDA decision allowing multiple generics on the market in April 2006 is upheld.

In a letter to Israeli generics firm Teva, FDA said it determined that exclusivity for prescription generics of several pravastatin doses expired in February 2005.

As a result, Teva, which believes it holds first-to-file rights on generic pravastatin 10 mg, 20 mg and 40 mg, will not receive a six-month exclusivity period, the company said in July 6.

Instead, as many as six generic companies - including Teva and Apotex - could be in a position to launch pravastatin generics when Pravachol loses exclusivity on April 20, 2006. Teva, Apotex, Ranbaxy, Sandoz, Ivax and Lek hold tentative approvals for various doses of pravastatin.

The presence of multiple generic competitors to Rx Pravachol would exert price pressure more quickly than a single generic would, leading to greater losses for the branded innovator.

However, a successful switch of the statin could soften the blow. Bristol would likely get three years exclusivity in the case of a switch, given the additional trials it has performed on the drug.

Schering-Plough brought the antihistamine Claritin OTC in 2002 as multiple generics awaited patent expiration. However, Schering did not have data to win exclusivity from FDA.

While Bristol has discussed selling its OTC division, including OTC Pravachol rights, the firm acknowledged its switch NDA program for the drug is still active.

Bayer will handle OTC marketing in the event of a switch, under an agreement with Bristol (¹ (Also see "Bayer Stake In OTC Pravachol Could Influence Bristol OTC Unit Divestiture" - Pink Sheet, 6 Jun, 2005.), p. 7 and ² (Also see "Pravachol OTC Deal Reached Between Bayer, Bristol" - Pink Sheet, 13 Dec, 2004.), p. 5).

In a letter to Teva explaining its decision, FDA said that any exclusivity period from patent nos. 5,030,447, 5,180,589, and 5,622,985 began on Aug. 22, 2004 - the date a court order dismissing a case filed by Apotex against Bristol over three Pravachol patents became final.

A fourth patent listed in FDA's "Orange Book" (no. 4,346,227) is the Pravachol composition of matter patent, which expires on April 20, 2006, following a six-month pediatric extension period.

"As the first applicant to file an ANDA under Paragraph IV of the Hatch-Waxman Act, Teva continues to believe that it is entitled to 180 days of marketing exclusivity for generic pravastatin tablets 10 mg, 20 mg, and 40 mg," the company asserted.

FDA appears to be using a 1999 lawsuit involving Roche's Ticlid (ticlopidine) to support its decision.

Teva said it "strongly disagrees" with FDA's interpretation of the case law and believes there are "significant distinctions between the facts surrounding the pravastatin dismissal and the prior case law."

"Teva will immediately pursue legal action to obtain reversal of the decision."

FDA's decision comes as a surprise to Teva: as recently as May 3, the company said it expected 180 days of exclusivity on the three lowest pravastatin doses.

"We're not aware that there's another player in front of us on Pravachol, and we believe that as far as we can see the patents were properly listed and first-to-file status is likely to hold up," North American CEO George Barrett said at the time.

Bristol also appears to have anticipated a 180-day exclusivity period for generic pravastatin.

In a discussion of the Apotex suit in a 10-Q filing with the Securities & Exchange Commission in August 2004, Bristol said the "initial generic ANDA filers, not including Apotex, are expected to have 180 days of semi-exclusivity after April 2006."

Bristol also markets an 80 mg dose of Pravachol.

Teva has nine months to resolve questions surrounding its first-to-file rights and is considering its legal and administrative options in response to FDA's decision.