1. Pink Sheet
  2. >>Legal & IP

FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change

 
• By Brenda Sandburg

FDA bows to a court ruling requiring it to award orphan drug market exclusivity to Depomed’s gabapentin, but the agency says it will continue to require the sponsor of a drug that is the “same” as a previously approved drug to show that it is “clinically superior” in order to be eligible.

FDA opted not to fight a court order requiring it to award Depomed Inc.’s Gralise (gabapentin) seven years of orphan drug market exclusivity. But the agency is not changing its policy on orphan exclusivity: a sponsor will still have to show its product is clinically superior to the same previously approved drug in order to win the designation.

In a Dec. 23 Federal Register notice

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

More from Pink Sheet

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
• By Sue Sutter

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.