Repotrectinib - Generic Drug Details

What are the generic sources for repotrectinib and what is the scope of freedom to operate?

Repotrectinib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Repotrectinib has one hundred and eight patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for repotrectinib

International Patents:	108
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Applications:	59
What excipients (inactive ingredients) are in repotrectinib?	repotrectinib excipients list
DailyMed Link:	repotrectinib at DailyMed

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

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

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.

Recent Clinical Trials for repotrectinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zai Lab (Shanghai) Co., Ltd.	Phase 3
Bristol-Myers Squibb	Phase 3
Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2

See all repotrectinib clinical trials

Pharmacology for repotrectinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors Tropomyosin Receptor Tyrosine Kinase A Inhibitors Tropomyosin Receptor Tyrosine Kinase B Inhibitors Tropomyosin Receptor Tyrosine Kinase C Inhibitors

US Patents and Regulatory Information for repotrectinib

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
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes				Y
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-001	Nov 15, 2023		RX	Yes	Yes
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No

International Patents for repotrectinib

Country	Patent Number	Title	Estimated Expiration
Japan	6817287
Croatia	P20221518
Lithuania	3319969
Spain	2735729
New Zealand	761094	Diaryl macrocycles as modulators of protein kinases
Israel	268820	דיאריל מקרוציקלים כמאפננים של פרוטאין קינאז (Diaryl macrocycles as modulators of protein kinases)
Denmark	3097107