Details for New Drug Application (NDA): 218213

NDA 218213 describes AUGTYRO, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the AUGTYRO profile page.

The generic ingredient in AUGTYRO is repotrectinib. One supplier is listed for this compound. Additional details are available on the repotrectinib profile page.

Summary for 218213

Tradename:	AUGTYRO
Applicant:	Bristol
Ingredient:	repotrectinib
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 218213

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC 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.

Pharmacology for NDA: 218213

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

Suppliers and Packaging for NDA: 218213

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4040	0003-4040-12	120 CAPSULE in 1 BOTTLE (0003-4040-12)
AUGTYRO	repotrectinib	CAPSULE;ORAL	218213	NDA	E.R. Squibb & Sons, L.L.C.	0003-4040	0003-4040-60	60 CAPSULE in 1 BOTTLE (0003-4040-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Nov 15, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 15, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Jun 13, 2031
Regulatory Exclusivity Use:	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC 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
Regulatory Exclusivity Expiration:	Nov 15, 2030
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY

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