Details for New Drug Application (NDA): 216157

NDA 216157 describes OXBRYTA, which is a drug marketed by Global Blood Theraps and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the OXBRYTA profile page.

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

Summary for 216157

Tradename:	OXBRYTA
Applicant:	Global Blood Theraps
Ingredient:	voxelotor
Patents:	10

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216157

Dosage:

TABLET, FOR SUSPENSION;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: 216157

Mechanism of Action

Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors

Suppliers and Packaging for NDA: 216157

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXBRYTA	voxelotor	TABLET, FOR SUSPENSION;ORAL	216157	NDA	Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.	72786-111	72786-111-02	60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-02)
OXBRYTA	voxelotor	TABLET, FOR SUSPENSION;ORAL	216157	NDA	Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.	72786-111	72786-111-03	90 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	300MG
Approval Date:	Dec 17, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 25, 2026
Regulatory Exclusivity Use:	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Regulatory Exclusivity Expiration:	Dec 17, 2028
Regulatory Exclusivity Use:	FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
Patent:		Patent Expiration:	Dec 28, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

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