cladribine · Emd Serono Inc · NDA 022561
Mavenclad
Blocked by patent: US 12533408, US 12539329. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 2 generic applications (ANDAs) for Mavenclad, though its earliest generic-entry date is 10 Sep 2041 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12533408 | use U-4395 · sets the listed date | 10 Sep 2041 |
| US 12539329 | use U-4399 · sets the listed date | 10 Sep 2041 |
| US 10849919 | use U-3411 | 23 Nov 2038 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 215547, Hopewell Pharma · 022561-001Approved 27 Mar 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 218425, Apotex · 022561-001Approved 24 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218425, Apotex · 022561-001Approved 24 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022561 · 001 · RLD | tablet, oral | 10MG | 10 Sep 2041 |