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 eleven patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and ninety-seven patent family members in forty-two 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 November 25, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OXBRYTA

International Patents:	297
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	5
Patent Applications:	211
Drug Prices:	Drug price information for OXBRYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Constraining patent/regulatory exclusivity:

10,493,035

NDA:

213137

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,018,210

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
Pfizer	Phase 1
Global Blood Therapeutics	Phase 2
Emory University	Phase 2

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

Paragraph IV (Patent) Challenges for OXBRYTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXBRYTA	Tablets	voxelotor	300 mg and 500 mg	213137	2	2023-11-27
OXBRYTA	Tablets for Oral Suspension	voxelotor	300 mg	216157	1	2023-11-27

US Patents and Regulatory Information for OXBRYTA

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

This potential generic entry date is based on patent 9,018,210.

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

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		DISCN	Yes	No	9,018,210		Y	Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-002	Oct 14, 2022		DISCN	Yes	No
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	11,944,612
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	9,248,199

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/004869Oxbryta 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

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Morocco

Netherlands

Nicaragua

Norway

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

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
Argentina	095339
Argentina	095340
Argentina	095341
Argentina	095342

Supplementary Protection Certificates for OXBRYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2797416	301191	Netherlands		PRODUCT NAME: VOXELOTOR OF EEN TAUTOMEER OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1622 20220215
2797416	CA 2022 00032	Denmark		PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215
2797416	PA2022517	Lithuania		PRODUCT NAME: VOKSELOTORAS ARBA TAUTOMERAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416	122022000052	Germany		PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; AUTHORISATION NO/DATE: EU/1/21/1622 20220214

DrugChatter Q&A for OXBRYTA

How does the drug oxbryta treat sickle cell disease?