Pfizer Obtains Preliminary Injunction Against Teva/Ranbaxy Accupril Generic

A preliminary injunction halting the sale of generic versions of Pfizer's Accupril (quinapril)may be a discouraging sign for generic companies considering "at risk" launches.

Under a ruling issued by Newark, N.J. federal Judge Dickinson Debevoise, Teva and Ranbaxy must immediately cease marketing and distribution of generic quinapril. The order is effective as of April 1. Ranbaxy said it will comply with the ruling.

Ranbaxy and Teva filed an appeal with the Federal Circuit Court of Appeals April 1 to have the injunction lifted.

The preliminary injunction may serve as a reminder to generic companies about the potential downside to launching products at risk.

The quinapril ruling comes just two months after the Federal Circuit reaffirmed that ANDA holders must establish a "reasonable apprehension" of suit in order to bring a declaratory judgment action for noninfringement (¹ (Also see "Declaratory Judgment Ruling Will Add Uncertainty To Generic Launches" - Pink Sheet, 31 Jan, 2005.), p. 33).

The Accupril decision also follows a string of significant at risk launches - such as generic competitors to Pfizer's Neurontin (gabapentin) and GlaxoSmithKline's Paxil (paroxetine).

Teva and Ranbaxy launched a generic version of Accupril under Ranbaxy's ANDA in December. The product was the first quinapril generic to enter the market (² 'The Pink Sheet' Dec. 20, 2004, In Brief).

Teva's own ANDA was approved in May 2003. The company was the first filer on quinapril; however, the product has not launched due to pending litigation with Pfizer (³ (Also see "Pfizer Accupril Patent Victory Could Lead To Influx Of Generics In 2005" - Pink Sheet, 5 Jul, 2004.), p. 11).

Teva and Ranbaxy entered an exclusive supply and distribution agreement for Ranbaxy's ANDA after Teva relinquished its 180-day exclusivity for generic Accupril, which paved the way for Ranbaxy's product to enter the market.

Pfizer subsequently filed suit against Ranbaxy and Teva in January, asserting that the generic infringed Pfizer's patent no. 4,743,450 (⁴ 'The Pink Sheet' Feb. 28, 2005, In Brief).

Pfizer said the court issued the preliminary injunction because it determined that Pfizer was "likely to prevail in its patent infringement case."

Assuming Pfizer is able obtain a permanent injunction, Teva and Ranbaxy would be prohibited from marketing their quinapril ANDA until 2007, when the '450 patent expires. The companies could also be liable for treble damages if Pfizer prevails in the patent suit.

Although the Teva/Ranbaxy deal stipulates that the two companies will share quinapril profits, Teva said it is not liable for infringement claims related to Ranbaxy's quinapril ANDA.

Although the preliminary injunction means that Pfizer may be able to recoup some lost Accupril sales in the form of damages, generic erosion of the ACE inhibitor has already begun to take effect.

At least two other generic version of Accupril are currently on the market.

Pfizer's Greenstone division launched a generic immediately following Teva/Ranbaxy's launch. Pfizer noted it is promoting its generic quinapril as well as the Accupril brand.

Par and licensing partner Amide also launched generic quinapril in late December after Amide's ANDA received final approval Dec. 22. Pfizer said it does not consider Par/Amide's ANDA to infringe its patents.

Four other generic firms hold ANDAs that have received final approval, including Mylan (Dec. 23), Andrx (Jan. 14), Par (Jan. 28) and Eon (March 2). Mutual's ANDA received tentative approval in July.

The launch of additional Accupril generics would not be too significant to Pfizer's bottom line.

The brand is a relatively small product for Pfizer, with U.S. sales of Accupril and Accuretic (quinapril/hydrochlorothiazide) of $387 mil. in 2004.

At least one more generic entry to the quinapril franchise is expected soon; Mylan announced April 1 it has received approval for its generic version of Accuretic.