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 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 |
Global Blood Therapeutics (GBT) | 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;ORAL | 213137-002 | Oct 14, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Global Blood Theraps | OXBRYTA | voxelotor | TABLET;ORAL | 213137-002 | Oct 14, 2022 | RX | Yes | No | ⤷ 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 | Y | Y | ⤷ 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 |
---|---|---|---|
Singapore | 11201507351P | COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN | ⤷ Sign Up |
Singapore | 11201403645V | SUBSTITUTED BENZALDEHYDE COMPOUNDS AND METHODS FOR THEIR USE IN INCREASING TISSUE OXYGENATION | ⤷ Sign Up |
Uruguay | 35426 | COMPUESTOS Y SUS USOS EN LA MODULACIÓN DE LA HEMOGLOBINA | ⤷ 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 | LUC00276 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: VOXELOTOR OR A TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/21/1622 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 | CR 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 |
>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.