exclusivity period


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Related to exclusivity period: Generic drugs

exclusivity period

In drug marketing, the time during which a manufacturer of a proprietary drug is allowed exercise monopoly rights to its sales.
See also: period
References in periodicals archive ?
The patent challenge exclusivity period enables the generic company to recoup its investment and, significantly, to invest in the development of additional patent challenges that create significant savings for consumers.
An authorized generic can compete in the generic marketplace at any time after initial generic entry, including during the 180-day "exclusivity period" awarded to a generic company that successfully challenges an innovator drug's patent through a "paragraph IV challenge," as well as after such an exclusivity period has ended.
The Company intends to promptly commence negotiations, through its Committee of Independent Trustees, with Cadim and PGI, and to assist them in their due diligence during the exclusivity period.
The 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act encourage early generic entry by providing an incentive of a 180-day exclusivity period for generics companies that successfully challenge brand-name drug patents.
Phar-Mor said Judge Bodoh's decision to extend the exclusivity period will give the Company more time to negotiate with its creditors and work toward a consensual plan of reorganization.
The Company also said that its senior secured lenders have filed a motion to terminate the Company's exclusivity period so that they may file their own plan of reorganization.
In addition to this three-year commercial exclusivity period, Inspire intends to pursue various possible forms of intellectual property protection to protect the commercialization of an intranasal epinastine product.
market exclusivity for generic products, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra[R], Neurontin[R] and Wellbutrin XL[R] , the effects of competition on our innovative products, especially Copaxone[R] sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.
In the motion, the companies requested that the exclusivity periods be extended to the earlier of April 18, 1995, or 90 days following the issuance of a decision in a Delaware Federal District Court trial, now in its fourth week, that will determine the validity of certain intercompany transactions that occurred prior to July 31, 1991, the date Columbia Transmission and The Columbia Gas System, Inc.