Afatinib Dimaleate Patent Expiration
Afatinib Dimaleate is Used for treating cancer, specifically advanced non-small cell lung cancer that has progressed after platinum-based chemotherapy. It was first introduced by Boehringer Ingelheim
Afatinib Dimaleate Patents
Given below is the list of patents protecting Afatinib Dimaleate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Gilotrif |
US10004743 (Pediatric) | Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient | Jan 05, 2031 | Boehringer Ingelheim |
| Gilotrif | US10004743 | Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient | Jul 05, 2030 | Boehringer Ingelheim |
| Gilotrif |
US8545884 (Pediatric) | Solid pharmaceutical formulations comprising BIBW 2992 | Jun 19, 2030 | Boehringer Ingelheim |
| Gilotrif |
US8426586 (Pediatric) | Process for preparing amino crotonyl compounds | Apr 10, 2030 | Boehringer Ingelheim |
| Gilotrif | US8545884 | Solid pharmaceutical formulations comprising BIBW 2992 | Dec 19, 2029 | Boehringer Ingelheim |
| Gilotrif | US8426586 | Process for preparing amino crotonyl compounds | Oct 10, 2029 | Boehringer Ingelheim |
| Gilotrif |
US9539258 (Pediatric) | Quinazoline derivatives for the treatment of cancer diseases | May 09, 2027 | Boehringer Ingelheim |
| Gilotrif | US9539258 | Quinazoline derivatives for the treatment of cancer diseases | Nov 09, 2026 | Boehringer Ingelheim |
| Gilotrif |
USRE43431 (Pediatric) | Quinazoline derivatives and pharmaceutical compositions containing them |
Jul 13, 2026
(Expired) | Boehringer Ingelheim |
| Gilotrif | USRE43431 | Quinazoline derivatives and pharmaceutical compositions containing them |
Jan 13, 2026
(Expired) | Boehringer Ingelheim |
| Gilotrif | US6251912 | Substituted quinazoline derivatives |
Jul 29, 2018
(Expired) | Boehringer Ingelheim |
Afatinib Dimaleate's Family Patents
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Clinical Trials
Recent Clinical Trials on Afatinib Dimaleate:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(Sep 1, 2026)
| PHASE2 |
| Exploratory Study of Inhaled Afatinib Dimaleate PK Profile | Petrov, Andrey | NA |
TERMINATED
(May 1, 2026)
| PHASE1 |