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Last Updated: April 24, 2024

Voxelotor - Generic Drug Details


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What are the generic drug 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*:
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
Duke UniversityPhase 2
Assistance Publique - Hôpitaux de ParisPhase 2
Global Blood Therapeutics (GBT)Phase 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;ORAL 213137-002 Oct 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Global Blood Theraps OXBRYTA voxelotor TABLET, FOR SUSPENSION;ORAL 216157-001 Dec 17, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 ⤷  Try a Trial
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-002 Oct 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-002 Oct 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y 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 Y ⤷  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

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
Argentina 110638 COMPRIMIDOS QUE COMPRENDEN 2-HIDROXI-6-((2-(1-ISOPROPIL-1H-PIRAZOL-5-IL)PIRIDIN-3-IL)METOXI)BENZALDEHÍDO ⤷  Try a Trial
Peru 20201444 POLIMORFOS CRISTALINOS DE LA BASE LIBRE DE 2-HIDROXI-6-((2-(1-ISOPROPIL-1H-PIRAZOL-5-IL)PIRIDIN-3-IL)METOXI)BENZALDEHIDO ⤷  Try a Trial
Uruguay 35472 COMPUESTOS Y SUS USOS EN LA MODULACION DE LA HEMOGLOBINA ⤷  Try a Trial
Peru 20160078 COMPUESTOS Y SUS USOS PARA MODULAR LA HEMOGLOBINA ⤷  Try a Trial
Australia 2021232806 SUBSTITUTED BENZALDEHYDE COMPOUNDS AND METHODS FOR THEIR USE IN INCREASING TISSUE OXYGENATION ⤷  Try a Trial
Japan 6426694 ⤷  Try a Trial
Israel 259798 משטרי מינון עבור 2-הידרוקסי-6-((2-(1-איזופרופיל-h1-פיראזול-5-איל)פירידין-3-איל)מתוקסי)בנזאלדהיד (Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for voxelotor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2797416 32/2022 Austria ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215
2797416 122022000052 Germany ⤷  Try a Trial PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 20220214
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 22C1042 France ⤷  Try a Trial PRODUCT NAME: VOXELOTOR OU UN TAUTOMERE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1622 20220215
2797416 CR 2022 00032 Denmark ⤷  Try a Trial PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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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