fingolimod hydrochloride · Novartis · NDA 022527
Gilenya
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.
FDA has approved 1 generic application (ANDA) for Gilenya, though its earliest generic-entry date is 25 Dec 2027 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 · 2 unexpired
3 Orange Book listing rows for 2 patents, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9592208 | drug product, use U-2315 | 30 Sep 2032 |
| US 9592208 listing row | drug product, use U-2315 | 30 Mar 2032 |
| US 9592208 listing row | pediatric extension | 30 Sep 2032 |
| US 10543179 | use U-2719 · sets the listed date | 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
- Generic approved · ANDA 207974, Alembic · 022527-001Approved 24 Apr 2026Detected 25 Oct 2026Historical import
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 |