Get Generic Drug Entry Prior To Patent Expiration: An FTC Study PDF

By Federal Trade Commission, United States Federal Trade Commission

This examine tested even if the behavior that the FTC challenged, which was once yes antitrust activities opposed to brand-name and time-honored drug businesses, represented remoted situations or is extra standard, and no matter if the 180-day exclusivity and the 30-month remain provisions of the Hatch- Waxman Amendments are liable to thoughts to hold up or deter patron entry to regular choices to model- identify drug items. The research focuses completely at the techniques used to facilitate familiar drug industry access sooner than expiration of the patent(s) that shield model- identify drug product.

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Extra info for Generic Drug Entry Prior To Patent Expiration: An FTC Study

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Settlements Involving Supply Agreements As part of two settlements, the brand-name company entered into a supply agreement that allowed the generic applicant to market the brand-name company’s product as a generic product. These agreements differ from the licenses described above because the generic applicant distributes the brand-name company’s drug and does not sell product pursuant to its ANDA. Miscellaneous Agreements with the First Generic Applicant Two additional agreements did not appear to raise issues related specifically to Hatch-Waxman.

Generic applicant settled (Table 2-3), (3) litigation with the second generic applicant was resolved, but either the first generic applicant was not sued or the case is pending (3 drug products), (4) litigation with a third generic applicant when the first two generic applicants had settled, and (5) follow-on litigation with the first generic applicants on two drug products described in footnote 9. Generic applicants prevailed for 29 out of 40 drug products (or 73 percent). Decisions involving 14 drug products held that the generic applicant did not infringe the patent, decisions involving 11 drug products held the relevant patent(s) invalid, and in 4 cases, the brand-name company abandoned the litigation with the first generic applicant before a decision of a court.

Pdf>. 3 For 3 out of the 4, see Abbott Laboratories, No. htm> (this consent order related to 2 drug products: Hytrin tablets and Hytrin capsules). , No. pdf>. 1 Brand-name and generic companies produced a range of other types of agreements relating to the drug products included in the study. These agreements are not discussed in this report. 25 Finally, in 6 instances (out of the 53 resolved cases noted in Chapter 2), the first and second generic applicants entered into agreements with each other that related to generic market entry.

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Generic Drug Entry Prior To Patent Expiration: An FTC Study by Federal Trade Commission, United States Federal Trade Commission


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