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Last Updated: April 19, 2024

Voxelotor - Generic Drug Details

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

Voxelotor is the generic ingredient in one branded drug marketed by Global Blood Theraps and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Voxelotor has two hundred and seventy-one patent family members in forty countries.

One supplier is listed for this compound.

Summary for voxelotor

International Patents:	271
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	16
Patent Applications:	174
What excipients (inactive ingredients) are in voxelotor?	voxelotor excipients list
DailyMed Link:	voxelotor at DailyMed

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

Generic Entry Dates for voxelotor^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL
Generic Entry Dates for voxelotor^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 voxelotor

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

Sponsor	Phase
Duke University	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 2
Global Blood Therapeutics (GBT)	Phase 2

See all voxelotor clinical trials

Pharmacology for voxelotor

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

Anatomical Therapeutic Chemical (ATC) Classes for voxelotor

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

Paragraph IV (Patent) Challenges for VOXELOTOR

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 voxelotor

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Glossary

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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, FOR SUSPENSION;ORAL	216157-001	Dec 17, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for voxelotor

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for voxelotor

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Country	Patent Number	Title	Estimated Expiration
Taiwan	201512169	Compounds and uses thereof for the modulation of hemoglobin	⤷ Try a Trial
Australia	2014237348	Compounds and uses thereof for the modulation of hemoglobin	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2014150258		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for voxelotor

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2797416	2290032-8	Sweden	⤷ Try a Trial	PRODUCT NAME: VOXELOTOR OR A TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1622 20220215
2797416	LUC00276	Luxembourg	⤷ Try a Trial	PRODUCT NAME: VOXELOTOR OR A TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/21/1622 20220215
2797416	301191	Netherlands	⤷ Try a Trial	PRODUCT NAME: VOXELOTOR OF EEN TAUTOMEER OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1622 20220215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.