Pfizer’s “Swift Response” To Neurontin Generics Gives Greenstone 23% Share
Executive Summary
Pfizer's Greenstone division held nearly a quarter of the generic gabapentin market share four days after the launch of AB-rated versions of Neurontin, Teva said in court filings
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Pfizer's Greenstone division held nearly a quarter of the generic gabapentin market share four days after the launch of AB-rated versions of Neurontin , Teva said in court filings. Teva held a 45.5% share of generic gabapentin sales on Oct. 12. Alpharma's Purepac division had a 23.5% share and Greenstone had 23%, Teva said in documents filed in D.C. federal court. Teva's filing cites market shares based on sales to large purchasers. Purepac, Teva and Greenstone launched generic versions of Pfizer's epilepsy agent within hours of each other on Oct. 8. Both the Purepac and Teva launches are "at risk." Teva's generic carries an average wholesale price 10% below that of the brand, according to Price Alert data. The court documents indicate Teva's customers for generic gabapentin include Walgreens, CVS, McKesson, Wal-Mart, Albertson's, Eckerd, HEB, Brooks, AmerisourceBergen and Walgreens. CVS' initial purchase from Teva totaled almost $2.5 mil., while McKesson's initial purchase was just shy of $1.7 mil. Greenstone's customers include Cardinal, Caremark, Rite Aid, Optisource, Harvard and Medco, according to Teva's court filings. Alpharma's customers include Kroger, AmerisourceBergen, ANDA, Ahold, Express Scripts, Kaiser and D&K, the filings indicate. The market share numbers were filed by Teva in connection with a request for a temporary restraining order to halt sales of Greenstone's generic gabapentin capsules and tablets. Purepac holds 180-day marketing exclusivity on the capsules, but Teva was allowed to enter the market immediately pursuant to an agreement between the two companies. Greenstone announced its launch after Teva came to market. The generic Neurontin market is likely to get more crowded soon. On Oct. 22, Alpharma announced it received ANDA approval with 180-day exclusivity for the 600 mg and 800 mg tablet doses. Ivax has been selling non-AB-rated gabapentin tablets in 100 mg, 300 mg and 400 mg strengths since August (1 (Also see "Ivax Launches Neurontin Generic “At Risk” As Pregabalin User Fee Date Nears" - Pink Sheet, 23 Aug, 2004.), p. 16). D.C. federal Judge Reggie Walton denied Teva's request for a TRO against Greenstone. The request was part of Teva's ongoing lawsuit challenging FDA's refusal to prohibit the marketing of "authorized" generics during an ANDA first-filer's exclusivity. Pfizer views "authorized" generics as a "legitimate business strategy" (2 (Also see "“Authorized” Generics Are “Legitimate Business Strategy,” Pfizer Says" - Pink Sheet, 18 Oct, 2004.), p. 24). During Pfizer's quarterly earnings call Oct. 20, Global Pharmaceuticals President Karen Katen cited Greenstone's "swift response" to the Teva/Purepac gabapentin capsule launches as evidence of the company's commitment to defend its products following loss of marketing exclusivity. The early fourth quarter entry of generics allowed Pfizer to report a full third quarter of Neurontin sales, which rose 11% in the U.S. to $632 mil. A court filing by Pfizer suggests the company has high expectations for retaining gabapentin market share. In an affidavit, Greenstone VP & General Manager William Kennally said that if the division is able to sell gabapentin capsules and tablets during the first filer's exclusivity period, "I believe that Greenstone will capture at least 50% of sales in the first 180 days and generate revenues of at least $400 mil." Neurontin was one of four products for which generic competition will result in substantial losses in 2005, Pfizer told investors during the earnings call. The other three are Diflucan , Accupril and Zithromax . Fluconazole generics, including one from Greenstone, entered the market in July following expiration of Diflucan's pediatric exclusivity. Third quarter sales of the brand reflected the generics' presence, falling 51% to $87 mil. Quinapril generics could enter the market next year despite a recent court ruling finding an Accupril patent to be valid (3 (Also see "Pfizer Accupril Patent Victory Could Lead To Influx Of Generics In 2005" - Pink Sheet, 5 Jul, 2004.), p. 11). The basic patent on Zithromax (azithromycin) expires in November 2005. |