Vitrakvi is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 16 US drug patents filed from 2018 to 2023 out of which none have expired yet. Vitrakvi's patents have been open to challenges since 26 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 04, 2037. Details of Vitrakvi'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. | |||
| US10799505 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Aug, 2036
(11 years from now) | Active |
| US10172861 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US8513263 | Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors |
Dec, 2029
(5 years from now) | Active |
| US9127013 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 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). | |||
| US11484535 | Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a] pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide |
Apr, 2037
(12 years from now) | Active |
| US10137127 | Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide |
Apr, 2037
(12 years from now) | Active |
| US10668072 | Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide |
Apr, 2037
(12 years from now) | Active |
| US10045991 | Methods of treating pediatric cancers |
Apr, 2037
(12 years from now) | Active |
| US11191766 | Methods of treating pediatric cancers |
Apr, 2037
(12 years from now) | Active |
| US9782414 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US9447104 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US10047097 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US8865698 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US10005783 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US9676783 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US10774085 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds |
Oct, 2029
(4 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 Vitrakvi's patents.
Latest Legal Activities on Vitrakvi's Patents
Given below is the list of recent legal activities going on the following patents of Vitrakvi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Apr, 2024 | US10813936 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Mar, 2024 | US10799505 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Mar, 2024 | US9447104 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Feb, 2024 | US10774085 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Nov, 2023 | US10668072 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9127013 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Nov, 2022 | US10285993 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2022 | US11484535 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2022 | US11484535 |
| Sequence Moved to Public Database | 01 Nov, 2022 | US11484535 |
FDA has granted several exclusivities to Vitrakvi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vitrakvi, 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 Vitrakvi.
Exclusivity Information
Vitrakvi holds 4 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Vitrakvi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 26, 2023 |
| Orphan Drug Exclusivity(ODE-215) | Nov 26, 2025 |
| Orphan Drug Exclusivity(ODE-220) | Nov 26, 2025 |
| Orphan Drug Exclusivity(ODE-221) | Nov 26, 2025 |
US patents provide insights into the exclusivity only within the United States, but Vitrakvi 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 Vitrakvi's family patents as well as insights into ongoing legal events on those patents.
Vitrakvi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vitrakvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 04, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vitrakvi Generics:
There are no approved generic versions for Vitrakvi as of now.
About Vitrakvi
Vitrakvi is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating various solid tumors in pediatric patients exhibiting an NTRK gene fusion. Vitrakvi uses Larotrectinib Sulfate as an active ingredient. Vitrakvi was launched by Bayer Healthcare in 2018.
Approval Date:
Vitrakvi was approved by FDA for market use on 26 November, 2018.
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 Vitrakvi is 26 November, 2018, its NCE-1 date is estimated to be 26 November, 2022.
Active Ingredient:
Vitrakvi uses Larotrectinib Sulfate as the active ingredient. Check out other Drugs and Companies using Larotrectinib Sulfate ingredient
Treatment:
Vitrakvi is used for treating various solid tumors in pediatric patients exhibiting an NTRK gene fusion.
Dosage:
Vitrakvi is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/ML | SOLUTION | Prescription | ORAL |
Vitrakvi is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 13 US drug patents filed from 2018 to 2021 out of which none have expired yet. Vitrakvi's patents have been open to challenges since 26 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2036. Details of Vitrakvi'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. | |||
| US10799505 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Aug, 2036
(11 years from now) | Active |
| US10172861 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US8513263 | Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors |
Dec, 2029
(5 years from now) | Active |
| US9127013 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 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). | |||
| US10813936 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-YL)-pyrazolo[1,5-A]pyrimidin-3-YL)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US9782414 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US10285993 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate |
Nov, 2035
(10 years from now) | Active |
| US10005783 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US9676783 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US10774085 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US8865698 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US10047097 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds |
Oct, 2029
(4 years from now) | Active |
| US9447104 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds |
Oct, 2029
(4 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 Vitrakvi's patents.
Latest Legal Activities on Vitrakvi's Patents
Given below is the list of recent legal activities going on the following patents of Vitrakvi.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Apr, 2024 | US10813936 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Mar, 2024 | US10799505 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Mar, 2024 | US9447104 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Feb, 2024 | US10774085 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Nov, 2023 | US10668072 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9127013 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Nov, 2022 | US10285993 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2022 | US11484535 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2022 | US11484535 |
| Sequence Moved to Public Database | 01 Nov, 2022 | US11484535 |
FDA has granted several exclusivities to Vitrakvi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vitrakvi, 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 Vitrakvi.
Exclusivity Information
Vitrakvi holds 4 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Vitrakvi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 26, 2023 |
| Orphan Drug Exclusivity(ODE-215) | Nov 26, 2025 |
| Orphan Drug Exclusivity(ODE-220) | Nov 26, 2025 |
| Orphan Drug Exclusivity(ODE-221) | Nov 26, 2025 |
US patents provide insights into the exclusivity only within the United States, but Vitrakvi 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 Vitrakvi's family patents as well as insights into ongoing legal events on those patents.
Vitrakvi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vitrakvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 15, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vitrakvi Generics:
There are no approved generic versions for Vitrakvi as of now.
About Vitrakvi
Vitrakvi is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating various solid tumors in pediatric patients exhibiting an NTRK gene fusion. Vitrakvi uses Larotrectinib Sulfate as an active ingredient. Vitrakvi was launched by Bayer Hlthcare in 2018.
Approval Date:
Vitrakvi was approved by FDA for market use on 26 November, 2018.
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 Vitrakvi is 26 November, 2018, its NCE-1 date is estimated to be 26 November, 2022.
Active Ingredient:
Vitrakvi uses Larotrectinib Sulfate as the active ingredient. Check out other Drugs and Companies using Larotrectinib Sulfate ingredient
Treatment:
Vitrakvi is used for treating various solid tumors in pediatric patients exhibiting an NTRK gene fusion.
Dosage:
Vitrakvi is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 100MG BASE | CAPSULE | Prescription | ORAL |