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Larotrectinib sulfate - Generic Drug Details
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What are the generic sources for larotrectinib sulfate and what is the scope of patent protection?
Larotrectinib sulfate
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and Bayer Healthcare, and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Larotrectinib sulfate has one hundred and forty-six patent family members in forty-two countries.
One supplier is listed for this compound.
Summary for larotrectinib sulfate
| International Patents: | 146 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 32 |
| DailyMed Link: | larotrectinib sulfate at DailyMed |
Pharmacology for larotrectinib sulfate
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tropomyosin Receptor Kinases Inhibitors |
US Patents and Regulatory Information for larotrectinib sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-002 | Nov 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-002 | Nov 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-001 | Nov 26, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for larotrectinib sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1118199 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016077841 | Start Trial |
| China | 107428760 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for larotrectinib sulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3106463 | 2020C/507 | Belgium | Start Trial | PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923 |
| 3106463 | 301033 | Netherlands | Start Trial | PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923 |
| 3106463 | 122020000012 | Germany | Start Trial | PRODUCT NAME: LAROTRECTINIB UND/ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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