OXBRYTA Drug Patent Profile

When do Oxbryta patents expire, and what generic alternatives are available?

Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are ten patents protecting this drug.

This drug has two hundred and sixty-three patent family members in thirty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Oxbryta

Oxbryta was eligible for patent challenges on November 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 6, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OXBRYTA

International Patents:	263
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	4
Patent Applications:	103
Drug Prices:	Drug price information for OXBRYTA
What excipients (inactive ingredients) are in OXBRYTA?	OXBRYTA excipients list
DailyMed Link:	OXBRYTA at DailyMed

See drug prices for OXBRYTA

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

NDA:

213137

Dosage:

TABLET;ORAL

NDA:

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.

Recent Clinical Trials for OXBRYTA

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

Sponsor	Phase
Emory University	Phase 2
Global Blood Therapeutics	Phase 2
Global Blood Therapeutics	Phase 4

See all OXBRYTA clinical trials

Pharmacology for OXBRYTA

Drug Class	Hemoglobin S Polymerization Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OXBRYTA

B06AX	Other hematological agents
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for OXBRYTA

OXBRYTA is protected by twelve US patents and three FDA Regulatory Exclusivities.

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 OXBRYTA

FDA Regulatory Exclusivity protecting OXBRYTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes			Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes			Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for OXBRYTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Oxbryta	Voxelotor	EMEA/H/C/004869 Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.	Authorised	no	no	yes	2022-02-14

International Patents for OXBRYTA

When does loss-of-exclusivity occur for OXBRYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OXBRYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Uruguay	35427	COMPUESTOS Y SUS USOS EN LA MODULACIÓN DE LA HEMOGLOBINA
Argentina	095342	PIRIDINAS 2,3-SUSTITUIDAS Y SU USO PARA LA MODULACIÓN DE HEMOGLOBINA
Singapore	11201507351P	COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN
World Intellectual Property Organization (WIPO)	2014150268

Supplementary Protection Certificates for OXBRYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2797416	122022000052	Germany		PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416	C202230036	Spain		PRODUCT NAME: VOXELOTOR O UN TAUTOMERO O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1622; DATE OF AUTHORISATION: 20220214; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1622; DATE OF FIRST AUTHORISATION IN EEA: 20220214
2797416	PA2022517	Lithuania		PRODUCT NAME: VOKSELOTORAS ARBA TAUTOMERAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416	CR 2022 00032	Denmark		PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215