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
Sponsor | Phase |
---|---|
Pfizer | Phase 1 |
Duke University | Phase 2 |
Assistance Publique - Hôpitaux de Paris | Phase 2 |
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
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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