afatinib dimaleate · Boehringer Ingelheim · NDA 201292
Gilotrif
Blocked by patent: US 10004743 (pediatric extension).
FDA has approved 2 generic applications (ANDAs) for Gilotrif, though its earliest generic-entry date is 5 Jan 2031 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 · 4 unexpired
8 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10004743 | drug product | 5 Jan 2031 |
| US 10004743 listing row | drug product | 5 Jul 2030 |
| US 10004743 listing row | pediatric extension · sets the listed date | 5 Jan 2031 |
| US 8545884 | drug product | 19 Jun 2030 |
| US 8545884 listing row | drug product | 19 Dec 2029 |
| US 8545884 listing row | pediatric extension | 19 Jun 2030 |
| US 8426586 | drug substance | 10 Apr 2030 |
| US 8426586 listing row | drug substance | 10 Oct 2029 |
| US 8426586 listing row | pediatric extension | 10 Apr 2030 |
| US 9539258 | use U-1950 | 9 May 2027 |
| US 9539258 listing row | use U-1950 | 9 Nov 2026 |
| US 9539258 listing row | pediatric extension | 9 May 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 tentatively approved · ANDA 210804, Msn Pharmaceuticals Inc · 201292-001Tentative approval 18 Feb 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 210750, Hetero Labs Ltd V · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 210750, Hetero Labs Ltd V · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 210725, Apotex · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 210725, Apotex · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201292 · 001 · RLD | tablet, oral | EQ 20MG BASE | 5 Jan 2031 |
| 201292 · 002 · RLD | tablet, oral | EQ 30MG BASE | 5 Jan 2031 |
| 201292 · 003 · RLD | tablet, oral | EQ 40MG BASE | 5 Jan 2031 |
Expired or delisted (2)
- US RE43431 · — · 13 Jul 2026
- US RE43431 · substance · 13 Jan 2026