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What Is Meant By 180 Day Exclusivity? |
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Answer» The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who CHALLENGES a listed patent by filing a PARAGRAPH IV certification and thereby RUNS the RISK of having to defend a patent infringement suit. 180 DAY Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium). The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit. 180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium). |
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