amantadine hydrochloride · Supernus Pharms · NDA 208944
Gocovri
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Aug 2038
Blocked by patent: US 11065213, US 11077073, US 12233033.
Listed patents · 13 unexpired
17 Orange Book listing rows for 13 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11065213 | drug product · sets the listed date | 23 Aug 2038 |
| US 11077073 | use U-2106, U-2224, U-3180 | 23 Aug 2038 |
| US 11077073 listing row | use U-2106 · sets the listed date | 23 Aug 2038 |
| US 11077073 listing row | use U-2224 · sets the listed date | 23 Aug 2038 |
| US 11077073 listing row | use U-3180 · sets the listed date | 23 Aug 2038 |
| US 12233033 | use U-2106, U-2224, U-3180 | 23 Aug 2038 |
| US 12233033 listing row | use U-2106 · sets the listed date | 23 Aug 2038 |
| US 12233033 listing row | use U-2224 · sets the listed date | 23 Aug 2038 |
| US 12233033 listing row | use U-3180 · sets the listed date | 23 Aug 2038 |
| US 10154971 | use U-2459 | 4 Dec 2034 |
| US 10646456 | use U-2808 | 17 Jun 2034 |
| US 11903908 | use U-3822 | 17 Jun 2034 |
| US 11197835 | use U-2106 | 2 Dec 2030 |
| US 8741343 | use U-2106 | 2 Dec 2030 |
| US 9867791 | use U-2106 | 2 Dec 2030 |
| US 9867792 | use U-2106 | 2 Dec 2030 |
| US 9867793 | use U-2106 | 2 Dec 2030 |
| US 9877933 | use U-2224 | 2 Dec 2030 |
| US 8389578 | use U-2105 | 22 Jan 2028 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208944 · 001 · RLD | capsule, extended release, oral | EQ 68.5MG BASE | 23 Aug 2038 |
| 208944 · 002 · RLD | capsule, extended release, oral | EQ 137MG BASE | 23 Aug 2038 |