fingolimod hydrochloride · Novartis · NDA 022527
Gilenya
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Dec 2027
Other strengths are listed to 30 Sep 2032.
Blocked by patent: US 10543179. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9592208 | — | 30 Sep 2032 |
| US 9592208 | product, use U-2315 | 30 Mar 2032 |
| US 10543179 | use U-2719 | 25 Dec 2027 |
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
- 25 Oct 2026Generic approved · 022527-00124 Apr 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022527 · 001 · RLD | capsule, oral | EQ 0.5MG BASE | 25 Dec 2027 |
| 022527 · 002 · RLD | capsule, oral | EQ 0.25MG BASE | 30 Sep 2032 |