Navigating the EU's Sweeping REACH Requirements: Nov. 30 Deadline Could Affect your Ability to Do Business
Product Details
Winning first-applicant status for 180-day generic marketing exclusivity used to come with a requirement: Market the generic product within 30 months of winning Abbreviated New Drug Application (ANDA) approval.
But in January, FDA letter rulings involving Teva Parenteral Medicines and Cobalt Pharmaceuticals changed everything. Now, brand-name drugmakers and generic drugmakers make deals to delay introducing the generic product, “parking” the exclusivity period. The result? Subsequent ANDA filers must honor the exclusivity period even though no generic is being marketed.
How can subsequent ANDA filers keep these from plugging development pipelines and profits?
Start by registering for Navigating the FDA’s New 180-Day Generic Marketing Exclusivity Rulings.
Antitrust and intellectual property experts Michael Keely and Chad Landmon explain the all-new filing and litigation strategies generic companies must use to keep product portfolios — and revenue — growing.
Order now for your entire team to listen in and discover:
- What you must know about congressional intent on the generic exclusivity forfeiture provisions — and why it matters to your strategy now
- Five filing and litigation changes generics companies must make to stay competitive
- How “parking” can affect patent settlements between ANDA filers and brand companies
- Best practices for navigating antitrust issues involved in settlements that “park” the exclusivity period.
With more brand drug patents up for review in the coming months, this audioconference helps provides practical, early-warning guidance on how to steer clear of roadblocks.