Entrectinib Patent Expiration
Entrectinib is used for treating solid tumors and cancers with specific genetic mutations. It was first introduced by Genentech Inc
Entrectinib Patents
Given below is the list of patents protecting Entrectinib, 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 |
|---|---|---|---|---|
| Rozlytrek | US10398693 | Pharmaceutical compositions and dosage forms | Jul 18, 2038 | Genentech Inc |
| Rozlytrek | US11253515 | Pharmaceutical compositions and dosage forms | Jul 18, 2038 | Genentech Inc |
| Rozlytrek | US10738037 | Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide | May 18, 2037 | Genentech Inc |
| Rozlytrek | US11091469 | Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide | May 18, 2037 | Genentech Inc |
| Rozlytrek | US10561651 | Methods for treating neuroblastoma | Feb 19, 2035 | Genentech Inc |
| Rozlytrek | US10231965 | Molecules for administration to ROS1 mutant cancer cells | Feb 17, 2035 | Genentech Inc |
| Rozlytrek | US9085565 | Process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide | May 22, 2033 | Genentech Inc |
| Rozlytrek | US9649306 | Treatment of diseases through administration of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide | May 22, 2033 | Genentech Inc |
| Rozlytrek | US8299057 | Substituted indazole derivatives active as kinase inhibitors | Mar 10, 2032 | Genentech Inc |
| Rozlytrek | US8673893 | Substituted indazole derivatives active as kinase inhibitors | Jul 08, 2028 | Genentech Inc |
| Rozlytrek | US9029356 | Substituted indazole derivatives active as kinase inhibitors | Jul 08, 2028 | Genentech Inc |
| Rozlytrek | US9085558 | Substituted indazole derivatives active as kinase inhibitors | Jul 08, 2028 | Genentech Inc |
| Rozlytrek | US9255087 | Substituted indazole derivatives active as kinase inhibitors | Jul 08, 2028 | Genentech Inc |
| Rozlytrek | US9616059 | Substituted indazole derivatives active as kinase inhibitors | Jul 08, 2028 | Genentech Inc |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or
decrease the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that
drug. Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in
the patent process of
the drug which can give an idea of how early a drug's generic could be available. The next
section provides a list
of recent legal activities on Entrectinib's patents.
Latest Legal Activities on Entrectinib's Patents
Given below is the list recent legal activities going on the following patents of Entrectinib.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Sep, 2025 | US8673893 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jul, 2025 | US11253515 |
| Patent Term Extension Certificate | 20 May, 2025 | US8299057 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Feb, 2025 | US11091469 |
| Withdrawal of Application for PTE | 31 Dec, 2024 | US9029356 |
| Withdrawal of Application for PTE | 31 Dec, 2024 | US8673893 |
| Withdrawal of Application for PTE | 31 Dec, 2024 | US9085565 |
| Notice of Final Determination -Election Required | 05 Dec, 2024 | US8299057 |
| Notice of Final Determination -Election Required | 05 Dec, 2024 | US8673893 |
| Notice of Final Determination -Election Required | 05 Dec, 2024 | US9029356 |
Entrectinib's Family Patents
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Clinical Trials
Recent Clinical Trials on Entrectinib:
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.
