Impax, Schering Patent Litigation Continues Despite Claritin-D Agreement
This article was originally published in The Tan Sheet
Executive Summary
Impax Labs' agreement to supply Schering-Plough with Claritin-D 12-Hour for OTC sale is not expected to attract Federal Trade Commission scrutiny due to its nonexclusivity provisions and lack of impact on pending patent litigation, the generics firm said
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Impax Labs' agreement to supply Schering-Plough with Claritin-D 12-Hour for OTC sale is not expected to attract Federal Trade Commission scrutiny due to its nonexclusivity provisions and lack of impact on pending patent litigation, the generics firm said. The licensing, contract manufacturing and supply agreement does not prevent Impax from licensing its loratadine 5 mg/pseudoephedrine sulfate 120 mg combination to other companies in the OTC market, Impax noted. However, the agreement does not resolve litigation between the two companies "to decide whether [Impax] may market its generic Claritin-D 12-Hour product or manufacture such a product for companies other than Schering-Plough prior to the expiration of a Schering-Plough patent in 2004," Impax said. The generics maker was the first to file an ANDA for the 12-hour product and, consequently, would be entitled to 180 days of exclusivity in the generic setting. Impax received tentative FDA approval for the 12-hour formulation May 29. Settlements between brand companies and first-to-file generic firms have attracted FTC scrutiny in the past. Schering is the subject of a pending FTC administrative complaint regarding the Rx potassium chloride supplement K-Dur . In April 2001, the agency charged Schering, Upsher-Smith Labs and American Home Products (now Wyeth) with entering anticompetitive agreements aimed at keeping generics off the market. Wyeth reached a consent order in the case in February; an administrative law judge's decision in the case against Schering and Upsher is expected soon. An FTC report on generic drug competition is slated for release in late July (1 (Also see "Generic Delay Tactics Evolving In Wake Of Consent Decrees – Initial FTC Data" - Pink Sheet, 13 May, 2002.), p. 17). Speaking at the Wachovia Securities 2002 Nantucket Equities Conference on June 26, Impax Co-CEO Barry Edwards said the company will be responsible for development and manufacturing under the Schering-Plough agreement, while Schering will handle sales and marketing. The deal, Edwards said, is structured differently than Impax' previously announced licensing and supply agreements with Novartis and Wyeth Consumer Healthcare for generic loratadine products. Those agreements include up-front and milestone payments, with "back end" royalties, the exec said. The Schering agreement "is more like a contract manufacturing" deal, Edwards stated. "We get up-front payments, milestones, then supply price moving forward." Impax said it is not pursuing additional partnerships for OTC loratadine. Although the particular loratadine formulation in the Novartis deal has not been publicly announced, it likely is a generic version of Claritin Reditabs. Impax' "semi-exclusive" worldwide agreement with Wyeth includes generic forms of Claritin-D 12- and 24-Hour (2 'The Tan Sheet' June 24, 2002, In Brief). Although Wyeth is rumored to be considering the brand name Alevert for its loratadine products, the company could opt to market the antihistamine under one of its established OTC brands, such as Dimetapp . Wyeth would not comment on a loratadine brand name. The imminent OTC switch of loratadine is spurring a flurry of licensing activity. On June 27, CIMA Labs announced it has entered into an exclusive license and supply agreement with Wyeth for a generic OTC version of Reditabs using CIMA's DuraSolv technology. CIMA says it will work with Wyeth "to complete the development and registration process, and will provide commercial supplies of DuraSolv loratadine." The company's fast-dissolve drug delivery technology currently is found in two OTC products: Novartis' Triaminic Softchews and Bristol-Myers Squibb's Tempra FirstTabs pediatric acetaminophen. Also on June 27, Taro Pharmaceutical Industries announced it has received tentative ANDA approval for loratadine syrup 10 mg/10mL. Taro said it is not first to file for the generic version of Claritin Syrup. As Claritin's Rx lifecycle nears its end, Schering has announced plans for a "strategic realignment of its Schering, Key and Primary Care sales forces," which will result in a slight reduction in headcount. |