augtyro Drug Patent Profile
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When do Augtyro patents expire, and when can generic versions of Augtyro launch?
Augtyro is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and eight patent family members in thirty-three countries.
The generic ingredient in AUGTYRO is repotrectinib. One supplier is listed for this compound. Additional details are available on the repotrectinib profile page.
DrugPatentWatch® Generic Entry Outlook for Augtyro
Augtyro will be eligible for patent challenges on November 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 13, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
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Summary for augtyro
International Patents: | 108 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Applications: | 34 |
Drug Prices: | Drug price information for augtyro |
What excipients (inactive ingredients) are in augtyro? | augtyro excipients list |
DailyMed Link: | augtyro at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for augtyro
Generic Entry Date for augtyro*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, ARE LOCALLY ADVANCED OR METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for augtyro
US Patents and Regulatory Information for augtyro
augtyro is protected by four US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of augtyro is ⤷ Subscribe.
This potential generic entry date is based on TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, ARE LOCALLY ADVANCED OR METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | 11,452,725 | ⤷ Subscribe | ⤷ Subscribe | ||||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | 9,714,258 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-002 | Jun 11, 2024 | RX | Yes | No | 9,714,258 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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 augtyro
See the table below for patents covering augtyro around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E045208 | ⤷ Subscribe | |
China | 108026109 | 手性二芳基大环及其用途 (CHIRAL DIARYL MACROCYCLES AND USES THEREOF) | ⤷ Subscribe |
Denmark | 3325488 | ⤷ Subscribe | |
Portugal | 3319969 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Augtyro Market Analysis and Financial Projection Experimental
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