Competitors have stepped up efforts to market genericversions of some of Wyeth’s biggest drugs, threatening to sap hundreds of millionsof dollars in sales.
Tevalaunched a generic version of Wyeth’s erosive GERD treatment Protonix (pantoprazole) DR tablets, then ceased shipmentdays later after reaching a 30-day standstill agreement with Wyeth, for thepurpose of negotiating a settlement. Protonix, whose compound patent doesn’t expireuntil July 2010, had USsales of about $2.5 billion for the 12 months ended September 30, accordingto IMS Health.
Wyethsaid it will pursue a patent infringement claim for lost profits and otherdamages resulting from the launch.
WhileTeva has not divulged the magnitude of the shipments, Robert Uhl, an analyst withFriedman, Billings, Ramsey, estimated that, between Friday and Monday when he believesthe copycat versions were halted, Teva shipped $150 million worth of genericpantoprazole, whose patent was exclusively licensed to Wyeth byAltana, the firm recently acquired by Nycomed.
The FDA had approved the generic in August. InSeptember a district court denied Wyeth’s motion for a preliminary injunctionthat would have stopped the generic. Wyeth did not have a strong patent case,the court stated.
Inanother patent threat, Sun Pharmaceuticals is seeking to market an alternativeformulation of Wyeth’s best-selling drug, the antidepressant Effexor XR.The Indian company wants to sell a tablet version, as opposed to the currentlymarketed capsule form, in an effort to skirt Wyeth’s patent rights. Exclusivityfor the active ingredient in Effexor, venlafaxine, is set to expire in June2008, while patent protection for the extended-release capsule formulationexpires later.
Wyeth already has told Sun it won’t sue for patentinfringement. Total Effexor sales are on pace to exceed $3.7 billion this year,according to the Associated Press.
Meanwhile, Wyeth’s efforts to bring new products to markethit another snag, as the FDA issued an approvable letter for Viviant(bazedoxifene), the second one issued this year for the pipeline drug, which Wyethhas filed for treating postmenopausal osteoporosis.
The FDA said several questions identified in its initialreview of the drug were not fully resolved by Wyeth in its response to thefirst approvable letter, issued in April. The agency did not request any newstudies, however.
Wyeth had sought to combine Viviant with estrogen in a pillfor treating hot flashes, Aprela. The Viviant setback followed multiple FDAdecisions to delay approval for two different versions of Effexor, for treating menopausal hotflashes and depression.
