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Executive Summary

Chase Labs is launching its generic nifedipine at a 30% discount to Pfizer's Procardia. Chase began shipping its generic nifedipine 10 mg gelatin capsules on Sept. 6 at price to wholesalers of $25 per bottle of 100s, and $73.30 for bottles of 300s. Chase's product is the first generic nifedipine to reach the market. Chase's nifedipine received prospective approval from FDA on July 10, 1989. However, the launch of the generic product was delayed by a patent dispute with Pfizer. Chase appears to have won a four-month monopoly on the generic nifedipine market until Jan. 8, 1991, when Pfizer's formulation and use patent for nifedipine expires. Under Waxman/Hatch, Chase could have started marketing its nifedipine on July 4 -- 30 months after Pfizer sued Chase for patent infringement in response to the firm filing its ANDA and patent challenge. However, under a consent agreement with Pfizer, Chase agreed to delay marketing until the judge hearing the patent case signed the order finalizing the consent decree. That hurdle was cleared on Sept. 4 in Newark District Court. Under the consent agreement, Pfizer "stipulates, for purposes of this Final Judgement on Consent only..., that the Chase ANDA's, and the dosage forms of nifedipine which are the subject of the Chase ANDAs, do not infringe any claim of the '684 Patent." The consent is "of no force and effect in any other proceedings." As the first to file an ANDA for nifedipine and challenge the pioneer drug patent, Chase would have been eligible to receive six months of marketing exclusivity, beginning July 4. The marketing delay to complete the court-approved consent has cost the generic firm two months of exclusivity in a market estimated by Chase to be about $500 mil. for all Procardia dosage forms. Chase estimates that $250 mil. of that market comes from sales of the 10 mg capsule. Chase also expects to receive approval "shortly" for its nifedipine 20 mg capsule. The success of Pfizer's launch of its once-daily Procardia XL is expected to limit the brandname product's erosion from generic competition. Launched last October, Procardia XL netted approximately $40 mil. in sales in its first three months on the market ("The Pink Sheet" April 30, p. 14). Sales of Procardia XL in the first six months of this year reportedly approached $100 mil., partly due to a direct-to-consumer ad campaign promoting potential cost-savings from switching from Procardia to the new one-a-day product. Chase's exclusive marketing of generic nifedipine may still hinge on the outcome of a lawsuit filed by Kalipharma against FDA in D.C. federal court in May. Kalipharma's Purepac subsidiary received the first ANDA approval for a generic nifedipine product on April 28. Seeking a court judgment revoking the six-month exclusivity granted to Chase by FDA the suit claims that Chase is not entitled to the exclusivity because its ANDA was not "substantially complete" at the time it was submitted to FDA in December 1987 ("The Pink Sheet" June 25, T&G-6). Chase had to clear an unexpected hurdle before marketing its generic nifedipine when the company received notice Aug. 23 from FDA that Chase's nifedipine ANDA was rescinded because of analytical work done on the application by Biodecision Labs. Chase filed suit against the agency in Newark federal court on Aug. 27. On Sept. 4, Chase won preliminary relief pending a final hearing by the court of the Chase complaint. According to Chase, FDA rescinded the application because the agency wanted Chase to conduct an audit on analytical work done by Biodecision Labs in support of the ANDA. Chase said that it subsequently audited the work and found it to be valid. In its suit, Chase contended that FDA had no authority to rescind the application since it was not pending but had been approved with a delayed effective date. The court awarded an injunction reinstating the status of the ANDA prior to the recision letter, Chase said. Chase is running ads for its nifedipine capsule in the September issues of Drug Topics, Pharmacy Times, American Druggist, and Drug Store News. The agency that created the ads is Jed Mark Advertising, Inc. of Totowa, New Jersey. Chase noted that it is spending in excess of $500,000 on its nifedipine ad campaign, which includes public relations activities.



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