Granules Pharmaceuticals’ Amphetamine Approval Analyzed
Granules Pharmaceuticals, a part of Granules India, recently got a “thumbs up” from the FDA for a new medicine called generic Amphetamine Extended-Release tablets. These tablets come in doses of 5mg, 10mg, 15mg, and 20mg and are exactly the same as a brand-name drug called DYANAVEL XR. This means more people can get this medicine at a lower price.
Key Points
- FDA approved Granules’ generic Amphetamine Extended-Release tablets.
- This medicine treats ADHD (Attention Deficit Hyperactivity Disorder).
- Market size for this drug is approximately $41 million.
- 180-day exclusivity granted by the FDA for increased market share.
- Granules’ success strengthens its ability to create generic drugs.
- Second approval in recent weeks highlights Granules’ growth.
About the Medicine
This generic drug helps people with ADHD. ADHD makes it hard for some people to focus and control their behavior. The medicine works to help manage these symptoms.
Market Opportunity
The FDA has given Granules a special period of time (180 days) where they can sell this medicine without facing much competition. This is because only one other company makes this exact medicine. This gives Granules a chance to sell a lot of tablets and make a good profit.
Previous Approval
Just a few weeks before, Granules also got approval for another ADHD medicine, ADZENYS XR-ODT. This new medicine dissolves quickly in your mouth. This shows Granules is getting really good at creating and selling generic medicines in the United States.
This approval demonstrates Granules Pharmaceuticals’ growing expertise in the U.S. generic drug market.
