dabrafenib mesylate · Novartis · NDA 202806, 217514
Tafinlar
Earliest generic entry, as listed · earliest of 3 marketed strengths
28 Feb 2034
Other strengths are listed to 29 Dec 2038.
Blocked by patent: US 10869869 (pediatric extension).
Listed patents · 7 unexpired
29 Orange Book listing rows for 7 patents, including 7 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11504333 | drug product | 29 Dec 2038 |
| US 11504333 listing row | drug product | 29 Jun 2038 |
| US 11504333 listing row | pediatric extension | 29 Dec 2038 |
| US 10869869 | use U-3185 | 28 Feb 2034 |
| US 10869869 listing row | use U-3185 | 30 Aug 2033 |
| US 10869869 listing row | pediatric extension · sets the listed date | 28 Feb 2034 |
| US 8703781 | drug substance, drug product, use U-1713, U-2032, U-2296, U-2298, U-3565 | 15 Apr 2031 |
| US 8703781 listing row | drug substance, drug product, use U-1713 | 15 Oct 2030 |
| US 8703781 listing row | drug substance, drug product, use U-2032 | 15 Oct 2030 |
| US 8703781 listing row | drug substance, drug product, use U-2296 | 15 Oct 2030 |
| US 8703781 listing row | drug substance, drug product, use U-2298 | 15 Oct 2030 |
| US 8703781 listing row | drug substance, drug product, use U-3565 | 15 Oct 2030 |
| US 8703781 listing row | pediatric extension | 15 Apr 2031 |
| US 8952018 | use U-2027 | 15 Apr 2031 |
| US 8952018 listing row | use U-2027 | 15 Oct 2030 |
| US 8952018 listing row | pediatric extension | 15 Apr 2031 |
| US 7994185 | drug substance, drug product, use U-1406, U-2031, U-2032, U-2296 | 20 Jul 2030 |
| US 7994185 listing row | drug substance, drug product | 20 Jan 2030 |
| US 7994185 listing row | drug substance, drug product, use U-1406 | 20 Jan 2030 |
| US 7994185 listing row | drug substance, drug product, use U-2031 | 20 Jan 2030 |
| US 7994185 listing row | drug substance, drug product, use U-2032 | 20 Jan 2030 |
| US 7994185 listing row | drug substance, drug product, use U-2296 | 20 Jan 2030 |
| US 7994185 listing row | pediatric extension | 20 Jul 2030 |
| US 8415345 | drug substance, drug product, use U-1406, U-2031, U-2032, U-2296 | 20 Jul 2030 |
| US 8415345 listing row | drug substance, drug product | 20 Jan 2030 |
| US 8415345 listing row | drug substance, drug product, use U-1406 | 20 Jan 2030 |
| US 8415345 listing row | drug substance, drug product, use U-2031 | 20 Jan 2030 |
| US 8415345 listing row | drug substance, drug product, use U-2032 | 20 Jan 2030 |
| US 8415345 listing row | drug substance, drug product, use U-2296 | 20 Jan 2030 |
| US 8415345 listing row | pediatric extension | 20 Jul 2030 |
| US 9233956 | use U-1811, U-2031, U-2032, U-2296 | 4 Nov 2029 |
| US 9233956 listing row | use U-1811 | 4 May 2029 |
| US 9233956 listing row | use U-2031 | 4 May 2029 |
| US 9233956 listing row | use U-2032 | 4 May 2029 |
| US 9233956 listing row | use U-2296 | 4 May 2029 |
| US 9233956 listing row | pediatric extension | 4 Nov 2029 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 16 Sep 2030 |
| ODE-428 | orphan drug (7 years) | 16 Mar 2030 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202806 · 001 · RLD | capsule, oral | EQ 50MG BASE | 28 Feb 2034 |
| 202806 · 002 · RLD | capsule, oral | EQ 75MG BASE | 28 Feb 2034 |
| 217514 · 001 · RLD | tablet, for suspension, oral | EQ 10MG BASE | 29 Dec 2038 |
Expired or delisted (3)
- PED · 16 Sep 2026
- I-908 · 16 Mar 2026
- NP · 16 Mar 2026