Competitors have stepped up efforts to market generic
versions of some of Wyeth's biggest drugs, threatening to sap hundreds of millions
of dollars in sales.
launched a generic version of Wyeth's erosive GERD treatment Protonix (pantoprazole) DR tablets, then ceased shipment
days later after reaching a 30-day standstill agreement with Wyeth, for the
purpose of negotiating a settlement. Protonix, whose compound patent doesn't expire
until July 2010, had US
sales of about $2.5 billion for the 12 months ended September 30, according
to IMS Health.
said it will pursue a patent infringement claim for lost profits and other
damages resulting from the launch.
Teva has not divulged the magnitude of the shipments, Robert Uhl, an analyst with
Friedman, Billings, Ramsey, estimated that, between Friday and Monday when he believes
the copycat versions were halted, Teva shipped $150 million worth of generic
pantoprazole, whose patent was exclusively licensed to Wyeth by
Altana, the firm recently acquired by Nycomed.
The FDA had approved the generic in August. In
September a district court denied Wyeth's motion for a preliminary injunction
that would have stopped the generic. Wyeth did not have a strong patent case,
the court stated.
another patent threat, Sun Pharmaceuticals is seeking to market an alternative
formulation of Wyeth's best-selling drug, the antidepressant Effexor XR.
The Indian company wants to sell a tablet version, as opposed to the currently
marketed capsule form, in an effort to skirt Wyeth's patent rights. Exclusivity
for the active ingredient in Effexor, venlafaxine, is set to expire in June
2008, while patent protection for the extended-release capsule formulation
Wyeth already has told Sun it won't sue for patent
infringement. 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 market
hit another snag, as the FDA issued an approvable letter for Viviant
(bazedoxifene), the second one issued this year for the pipeline drug, which Wyeth
has filed for treating postmenopausal osteoporosis.
The FDA said several questions identified in its initial
review of the drug were not fully resolved by Wyeth in its response to the
first approvable letter, issued in April
. The agency did not request any new
Wyeth had sought to combine Viviant with estrogen in a pill
for treating hot flashes, Aprela. The Viviant setback followed multiple FDA
decisions to delay approval for two different versions of Effexor, for treating menopausal hot
flashes and depression.