Larotrectinib Sulfate Patent Expiration
Larotrectinib Sulfate is Used for treating various solid tumors in pediatric patients exhibiting an NTRK gene fusion. It was first introduced by Bayer Healthcare Pharmaceuticals Inc
Larotrectinib Sulfate Patents
Given below is the list of patents protecting Larotrectinib Sulfate, 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 |
|---|---|---|---|---|
| Vitrakvi | US11337967 | Methods of treatment | May 16, 2037 | Bayer Healthcare |
| Vitrakvi | US11337967 | Methods of treatment | May 16, 2037 | Bayer Hlthcare |
| Vitrakvi | US11974998 | Methods of treatment | May 16, 2037 | Bayer Healthcare |
| Vitrakvi | US11974998 | Methods of treatment | May 16, 2037 | Bayer Hlthcare |
| Vitrakvi | US10045991 | Methods of treating pediatric cancers | Apr 04, 2037 | Bayer Healthcare |
| Vitrakvi | 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 04, 2037 | Bayer Healthcare |
| Vitrakvi | 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 04, 2037 | Bayer Healthcare |
| Vitrakvi | US11191766 | Methods of treating pediatric cancers | Apr 04, 2037 | Bayer Healthcare |
| Vitrakvi | 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 04, 2037 | Bayer Healthcare |
| Vitrakvi | 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 15, 2036 | Bayer Healthcare |
| Vitrakvi | 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 15, 2036 | Bayer Hlthcare |
| Vitrakvi | 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 16, 2035 | Bayer Healthcare |
| Vitrakvi | 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 16, 2035 | Bayer Hlthcare |
| Vitrakvi | 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 16, 2035 | Bayer Hlthcare |
| Vitrakvi | 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 16, 2035 | Bayer Hlthcare |
| Vitrakvi | 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 16, 2035 | Bayer Healthcare |
| Vitrakvi | 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 16, 2035 | Bayer Hlthcare |
| Vitrakvi | US8513263 | Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors | Dec 23, 2029 | Bayer Healthcare |
| Vitrakvi | US8513263 | Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors | Dec 23, 2029 | Bayer Hlthcare |
| Vitrakvi | US10005783 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US10005783 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US10047097 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US10047097 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US10774085 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US10774085 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US8865698 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US8865698 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US9127013 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US9127013 | Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US9447104 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US9447104 | Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
| Vitrakvi | US9676783 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds | Oct 21, 2029 | Bayer Healthcare |
| Vitrakvi | US9676783 | Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds | Oct 21, 2029 | Bayer Hlthcare |
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 Larotrectinib Sulfate's patents.
Latest Legal Activities on Larotrectinib Sulfate's Patents
Given below is the list recent legal activities going on the following patents of Larotrectinib Sulfate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Jan, 2026 | US10047097 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Jan, 2026 | US10045991 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Dec, 2025 | US10005783 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 May, 2025 | US11191766 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Mar, 2025 | US9782414 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Jan, 2025 | US8513263 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Nov, 2024 | US9676783 |
| Email Notification | 27 Aug, 2024 | US11191766 |
| Mail Patent eCofC Notification | 27 Aug, 2024 | US11191766 |
| Patent eCofC Notification | 27 Aug, 2024 | US11191766 |
Larotrectinib Sulfate's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Larotrectinib Sulfate:
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 |
|---|---|---|---|---|
 | ||||
| Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial) | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(May 1, 2026)
| PHASE2 |
| Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors | M.D. Anderson Cancer Center | NA |
RECRUITING
(Apr 1, 2026)
| PHASE2 |