AUGTYRO Drug Patent Profile
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Which patents cover Augtyro, and what generic alternatives are available?
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 one patent family members in thirty-two 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 15, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AUGTYRO
International Patents: | 101 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
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 PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY 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.
US Patents and Regulatory Information for AUGTYRO
AUGTYRO is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AUGTYRO is ⤷ Try a Trial.
This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AUGTYRO
Diaryl macrocycle polymorph
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Diaryl macrocycles as modulators of protein kinases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting AUGTYRO
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 AUGTYRO
See the table below for patents covering AUGTYRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112018000297 | polimorfo de macrociclo de diarila | ⤷ Try a Trial |
Lithuania | 3097107 | ⤷ Try a Trial | |
Israel | 256443 | פולימורפ מקרוציקלי דיארילי (Diaryl macrocycle polymorph) | ⤷ Try a Trial |
Denmark | 3097107 | ⤷ Try a Trial | |
Lithuania | 3572416 | ⤷ Try a Trial | |
Brazil | 112018001065 | macrociclos diarila quirais e usos dos mesmos | ⤷ Try a Trial |
South Korea | 20160111395 | 단백질 키나제의 조절인자로서의 다이아릴 거대환 (DIARYL MACROCYCLES AS MODULATORS OF PROTEIN KINASES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |