An In-Depth Look at Hatch-Waxman 180- Day Exclusivity
Brad Graveline
Partner
Sheppard, Mullin, Richter & Hampton LLP
Tara M. Raghavan
Partner
Benesch Friedlander Coplan & Aronoff LLP
- Understanding 180-day generic market exclusivity under the Hatch-Waxman Act
- What are the qualifying criteria for exclusivity?
- How can an ANDA applicant really determine who is “first-to-file” and win 180 –day exclusivity?
- Identifying triggers for the running of the 180-day exclusivity period
- Deciphering the FDA’s new interpretation of pre- and post- MMA 180 day exclusivity
- What are the implications of this interpretation for products having ANDA’s filed prior to the enactment of the MMA?
- Exploring the interplay between the 30-month stay and 180-day exclusivity
- Forfeiture provisions: identifying circumstances under which exclusivity is forfeited
- Other circumstances that may trigger the loss of 180-day exclusivity
- When can the 180-day exclusivity period be transferred to another ANDA applicant?
- Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences defining “shared exclusivity”