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Last Updated: March 28, 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 patent family members in forty countries.

One supplier is listed for this compound.

Summary for voxelotor
International Patents:270
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 213137-001 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 213137-001 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

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
South Korea 20190041548 헤모글로빈 조정을 위한 화합물 및 이의 용도 (COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN) ⤷  Try a Trial
Slovenia 3141542 ⤷  Try a Trial
Brazil 112018011272 regimes de dosagem para 2-hidróxi-6-((2-(1-isopropil-1h-pirazol-5-il)piridin-3-il)metóxi)benzaldeído ⤷  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 2022C/537 Belgium ⤷  Try a Trial PRODUCT NAME: VOXELOTOR OU UN TAUTOMERE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1622 20220215
2797416 PA2022517 Lithuania ⤷  Try a Trial PRODUCT NAME: VOKSELOTORAS ARBA TAUTOMERAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1622 20220214
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.