Rozlytrek is a drug owned by Genentech Inc. It is protected by 14 US drug patents filed from 2019 to 2022 out of which none have expired yet. Rozlytrek's patents have been open to challenges since 16 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2038. Details of Rozlytrek's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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, 2037
(11 years from now) | Active |
| 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, 2033
(7 years from now) | Active |
| US8299057 | Substituted indazole derivatives active as kinase inhibitors |
Mar, 2032
(6 years from now) | Active |
| US9029356 | Substituted indazole derivatives active as kinase inhibitors |
Jul, 2028
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11253515 | Pharmaceutical compositions and dosage forms |
Jul, 2038
(13 years from now) | Active |
| US10398693 | Pharmaceutical compositions and dosage forms |
Jul, 2038
(13 years from now) | Active |
| 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, 2037
(11 years from now) | Active |
| US10561651 | Methods for treating neuroblastoma |
Feb, 2035
(9 years from now) | Active |
| US10231965 | Molecules for administration to ROS1 mutant cancer cells |
Feb, 2035
(9 years from now) | Active |
| 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, 2033
(7 years from now) | Active |
| US9616059 | Substituted indazole derivatives active as kinase inhibitors |
Jul, 2028
(2 years from now) | Active |
| US9085558 | Substituted indazole derivatives active as kinase inhibitors |
Jul, 2028
(2 years from now) | Active |
| US8673893 | Substituted indazole derivatives active as kinase inhibitors |
Jul, 2028
(2 years from now) | Active |
| US9255087 | Substituted indazole derivatives active as kinase inhibitors |
Jul, 2028
(2 years from now) | Active |
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 Rozlytrek's patents.
Latest Legal Activities on Rozlytrek's Patents
Given below is the list of recent legal activities going on the following patents of Rozlytrek.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Apr, 2024 | US8299057 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Feb, 2024 | US10738037 |
| FDA Final Eligibility Letter Critical | 25 Jan, 2024 | US8299057 |
| FDA Final Eligibility Letter Critical | 25 Jan, 2024 | US9029356 |
| FDA Final Eligibility Letter Critical | 25 Jan, 2024 | US8673893 |
| FDA Final Eligibility Letter Critical | 25 Jan, 2024 | US9085565 |
| transaction for FDA Determination of Regulatory Review Period | 17 Nov, 2023 | US9029356 |
| transaction for FDA Determination of Regulatory Review Period | 17 Nov, 2023 | US8299057 |
| transaction for FDA Determination of Regulatory Review Period | 17 Nov, 2023 | US8673893 |
| transaction for FDA Determination of Regulatory Review Period | 17 Nov, 2023 | US9085565 |
FDA has granted several exclusivities to Rozlytrek. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rozlytrek, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rozlytrek.
Exclusivity Information
Rozlytrek holds 7 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Rozlytrek's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 15, 2024 |
| ODE*(ODE*) | Aug 15, 2026 |
| Orphan Drug Exclusivity(ODE-265) | Aug 15, 2026 |
| Orphan Drug Exclusivity(ODE-313) | Aug 15, 2026 |
| New Product(NP) | Oct 20, 2026 |
| New Patient Population(NPP) | Oct 20, 2026 |
| Orphan Drug Exclusivity(ODE-448) | Oct 20, 2030 |
US patents provide insights into the exclusivity only within the United States, but Rozlytrek is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rozlytrek's family patents as well as insights into ongoing legal events on those patents.
Rozlytrek's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rozlytrek's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rozlytrek Generics:
There are no approved generic versions for Rozlytrek as of now.
About Rozlytrek
Rozlytrek is a drug owned by Genentech Inc. It is used for treating solid tumors and cancers with specific genetic mutations. Rozlytrek uses Entrectinib as an active ingredient. Rozlytrek was launched by Genentech Inc in 2019.
Approval Date:
Rozlytrek was approved by FDA for market use on 15 August, 2019.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rozlytrek is 15 August, 2019, its NCE-1 date is estimated to be 16 August, 2023.
Active Ingredient:
Rozlytrek uses Entrectinib as the active ingredient. Check out other Drugs and Companies using Entrectinib ingredient
Treatment:
Rozlytrek is used for treating solid tumors and cancers with specific genetic mutations.
Dosage:
Rozlytrek is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | CAPSULE | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |