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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

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 November 15, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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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

Drug patent expirations by year for AUGTYRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AUGTYRO

Generic Entry Date for AUGTYRO^: ⤷ Sign Up* 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: 218213 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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AUGTYRO is ⤷ Sign Up.

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Malaysia	193524	DIARYL MACROCYCLES AS MODULATORS OF PROTEIN KINASES	⤷ Sign Up
Japan	2019104748	タンパク質キナーゼのモジュレータとしてのジアリール大環状化合物 (DIARYL MACROCYCLIC COMPOUNDS AS MODULATORS OF PROTEIN KINASES)	⤷ Sign Up
Mexico	2016009588	MACROCICLOS DE DIARILO COMO MODULADORES DE LA PROTEINA QUINASA. (DIARYL MACROCYCLES AS MODULATORS OF PROTEIN KINASES.)	⤷ Sign Up
Poland	3572416		⤷ Sign Up
Taiwan	202035425	Diaryl macrocycles as modulators of protein kinases	⤷ Sign Up
China	108026108	二芳基大环多晶型物 (DIARYL MACROCYCLE POLYMORPH)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for AUGTYRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AUGTYRO

Patents protecting AUGTYRO

FDA Regulatory Exclusivity protecting AUGTYRO

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AUGTYRO