fenfluramine hydrochloride · Ucb Inc · NDA 212102
Fintepla
Earliest generic entry, as listed
29 Dec 2038
Blocked by patent: US 10452815 (pediatric extension).
Listed patents · 14 unexpired
30 Orange Book listing rows for 14 patents, including 14 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10452815 | pediatric extension · sets the listed date | 29 Dec 2038 |
| US 10603290 | use U-2861, U-3347 | 2 Feb 2038 |
| US 10603290 listing row | use U-2861 | 2 Aug 2037 |
| US 10603290 listing row | use U-3347 | 2 Aug 2037 |
| US 10603290 listing row | pediatric extension | 2 Feb 2038 |
| US 11040018 | use U-2861, U-3347 | 2 Feb 2038 |
| US 11040018 listing row | use U-2861 | 2 Aug 2037 |
| US 11040018 listing row | use U-3347 | 2 Aug 2037 |
| US 11040018 listing row | pediatric extension | 2 Feb 2038 |
| US 11406606 | use U-3406, U-3407 | 2 Feb 2038 |
| US 11406606 listing row | use U-3406 | 2 Aug 2037 |
| US 11406606 listing row | use U-3407 | 2 Aug 2037 |
| US 11406606 listing row | pediatric extension | 2 Feb 2038 |
| US 11759440 | use U-3694 | 2 Feb 2038 |
| US 11759440 listing row | use U-3694 | 2 Aug 2037 |
| US 11759440 listing row | pediatric extension | 2 Feb 2038 |
| US 11786487 | use U-3733 | 2 Feb 2038 |
| US 11786487 listing row | use U-3733 | 2 Aug 2037 |
| US 11786487 listing row | pediatric extension | 2 Feb 2038 |
| US 10947183 | drug substance, drug product | 20 Jun 2037 |
| US 10947183 listing row | drug substance, drug product | 20 Dec 2036 |
| US 10947183 listing row | pediatric extension | 20 Jun 2037 |
| US 10478441 | use U-2860 | 3 Nov 2033 |
| US 10478441 listing row | use U-2860 | 3 May 2033 |
| US 10478441 listing row | pediatric extension | 3 Nov 2033 |
| US 10478442 | use U-2860 | 3 Nov 2033 |
| US 10478442 listing row | use U-2860 | 3 May 2033 |
| US 10478442 listing row | pediatric extension | 3 Nov 2033 |
| US 12097206 | use U-4013 | 3 Nov 2033 |
| US 12097206 listing row | use U-4013 | 3 May 2033 |
| US 12097206 listing row | pediatric extension | 3 Nov 2033 |
| US 9549909 | use U-2858 | 3 Nov 2033 |
| US 9549909 listing row | use U-2858 | 3 May 2033 |
| US 9549909 listing row | pediatric extension | 3 Nov 2033 |
| US 9603814 | use U-2858 | 3 Nov 2033 |
| US 9603814 listing row | use U-2858 | 3 May 2033 |
| US 9603814 listing row | pediatric extension | 3 Nov 2033 |
| US 9603815 | use U-2858 | 3 Nov 2033 |
| US 9603815 listing row | use U-2858 | 3 May 2033 |
| US 9603815 listing row | pediatric extension | 3 Nov 2033 |
| US 9610260 | use U-2858 | 3 Nov 2033 |
| US 9610260 listing row | use U-2858 | 3 May 2033 |
| US 9610260 listing row | pediatric extension | 3 Nov 2033 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 25 Sep 2029 |
| ODE-393 | orphan drug (7 years) | 25 Mar 2029 |
| PED | pediatric (6 months added) | 25 Dec 2027 |
| ODE-312 | orphan drug (7 years) | 25 Jun 2027 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212102 · 001 · RLD | solution, oral | EQ 2.2MG BASE/ML | 29 Dec 2038 |
Expired or delisted (1)
- US 10452815 · use U-2859 · 29 Jun 2038 · delisted