Alkem Drug Patent Portfolio

Alkem's Family Patents


Family Patents



Recent FDA approvals and tentative approvals for Alkem

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


Generic drugs

Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.

Drug Name Submission class (FDA) Submission Category Submission Date
Bempedoic Acid And Ezetimibe ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 23 Oct, 2025
Sodium Zirconium Cyclosilicate ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 08 Oct, 2025
Lumateperone ORIG-1
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 27 May, 2025

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List