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Last Updated: October 13, 2024

VOXELOTOR - Generic Drug Details


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What are the generic sources for voxelotor and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for VOXELOTOR
International Patents:275
US Patents:11
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 17
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*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for VOXELOTOR*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
PfizerPhase 1
Duke UniversityPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2

See all VOXELOTOR clinical trials

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

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-002 Oct 14, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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

Country Patent Number Title Estimated Expiration
Denmark 3141542 ⤷  Sign Up
Australia 2017232206 SUBSTITUTED BENZALDEHYDE COMPOUNDS AND METHODS FOR THEIR USE IN INCREASING TISSUE OXYGENATION ⤷  Sign Up
Japan 2021104996 置換ベンズアルデヒド化合物および組織酸素化の増加におけるそれらの使用方法 (SUBSTITUTED BENZALDEHYDE COMPOUND AND METHOD FOR THEIR USE IN INCREASING TISSUE OXYGENATION) ⤷  Sign Up
South Korea 20150132147 헤모글로빈 조정을 위한 화합물 및 이의 용도 (COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN) ⤷  Sign Up
European Patent Office 3141542 COMPOSÉS BENZALDÉHYDE SUBSTITUÉS ET PROCÉDÉS D'UTILISATION DE CEUX-CI DANS L'AUGMENTATION DE L'OXYGÉNATION DES TISSUS (SUBSTITUTED BENZALDEHYDE COMPOUNDS AND METHODS FOR THEIR USE IN INCREASING TISSUE OXYGENATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VOXELOTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2797416 22C1042 France ⤷  Sign Up PRODUCT NAME: VOXELOTOR OU UN TAUTOMERE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1622 20220215
2797416 32/2022 Austria ⤷  Sign Up PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 (MITTEILUNG) 20220215
2797416 CA 2022 00032 Denmark ⤷  Sign Up PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215
2797416 2290032-8 Sweden ⤷  Sign Up PRODUCT NAME: VOXELOTOR OR A TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1622 20220215
2797416 2022C/537 Belgium ⤷  Sign Up PRODUCT NAME: VOXELOTOR OU UN TAUTOMERE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND 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.