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Last Updated: September 25, 2022

OXBRYTA Drug Patent Profile


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When do Oxbryta patents expire, and what generic alternatives are available?

Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are nine patents protecting this drug.

This drug has two hundred and forty-three patent family members in thirty-seven countries.

The generic ingredient in OXBRYTA is voxelotor. Additional details are available on the voxelotor profile page.

DrugPatentWatch® Generic Entry Outlook for Oxbryta

Oxbryta will be eligible for patent challenges on November 25, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 6, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OXBRYTA
International Patents:243
US Patents:9
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 4
Patent Applications: 77
Drug Prices: Drug price information for OXBRYTA
What excipients (inactive ingredients) are in OXBRYTA?OXBRYTA excipients list
DailyMed Link:OXBRYTA at DailyMed
Drug patent expirations by year for OXBRYTA
Drug Prices for OXBRYTA

See drug prices for OXBRYTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for OXBRYTA
Generic Entry Dates for OXBRYTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for OXBRYTA*:
Constraining patent/regulatory exclusivity:
NDA:
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 OXBRYTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Emory UniversityPhase 2
Global Blood TherapeuticsPhase 2
Global Blood TherapeuticsPhase 4

See all OXBRYTA clinical trials

US Patents and Regulatory Information for OXBRYTA

OXBRYTA is protected by eleven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OXBRYTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OXBRYTA

Compounds and uses thereof for the modulation of hemoglobin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING SICKLE CELL DISEASE BY ADMINISTERING 1500 MG OF VOXELOTOR ORALLY ONCE DAILY

Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASING HEMOGLOBIN TO TREAT SICKLE CELL DISEASE BY ADMINISTERING 1500 MG OF VOXELOTOR ORALLY ONCE DAILY

Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

1:1 adducts of sickle hemoglobin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 1

1:1 adducts of sickle hemoglobin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 2

Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting OXBRYTA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Global Blood Theraps OXBRYTA voxelotor TABLET;ORAL 213137-001 Nov 25, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Global Blood Theraps OXBRYTA voxelotor TABLET, FOR SUSPENSION;ORAL 216157-001 Dec 17, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 OXBRYTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Global Blood Therapeutics Netherlands B. V. 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 OXBRYTA

When does loss-of-exclusivity occur for OXBRYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9304
Estimated Expiration: See Plans and Pricing

Patent: 0638
Estimated Expiration: See Plans and Pricing

Australia

Patent: 15214182
Estimated Expiration: See Plans and Pricing

Patent: 20207778
Estimated Expiration: See Plans and Pricing

Patent: 22203213
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015032160
Estimated Expiration: See Plans and Pricing

Patent: 2019006506
Estimated Expiration: See Plans and Pricing

Canada

Patent: 16564
Estimated Expiration: See Plans and Pricing

China

Patent: 5431147
Estimated Expiration: See Plans and Pricing

Patent: 4181194
Estimated Expiration: See Plans and Pricing

Patent: 4181195
Estimated Expiration: See Plans and Pricing

Patent: 4213390
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0210388
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 02208
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8529
Estimated Expiration: See Plans and Pricing

Patent: 1592212
Estimated Expiration: See Plans and Pricing

Patent: 1791587
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 02208
Estimated Expiration: See Plans and Pricing

Patent: 25766
Estimated Expiration: See Plans and Pricing

Patent: 68745
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 53706
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3214
Estimated Expiration: See Plans and Pricing

Patent: 5777
Estimated Expiration: See Plans and Pricing

Patent: 5918
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09681
Estimated Expiration: See Plans and Pricing

Patent: 17505347
Estimated Expiration: See Plans and Pricing

Patent: 19137699
Estimated Expiration: See Plans and Pricing

Patent: 21113225
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 02208
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1810
Estimated Expiration: See Plans and Pricing

Patent: 15017614
Estimated Expiration: See Plans and Pricing

Patent: 19004120
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 522
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5029
Estimated Expiration: See Plans and Pricing

Peru

Patent: 160179
Estimated Expiration: See Plans and Pricing

Patent: 201444
Estimated Expiration: See Plans and Pricing

Poland

Patent: 02208
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 02208
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 6370358
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 653
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201804139V
Estimated Expiration: See Plans and Pricing

Patent: 201911662Y
Estimated Expiration: See Plans and Pricing

Patent: 201911668V
Estimated Expiration: See Plans and Pricing

Patent: 201510135X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 02208
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2345380
Estimated Expiration: See Plans and Pricing

Patent: 160118204
Estimated Expiration: See Plans and Pricing

Patent: 220002722
Estimated Expiration: See Plans and Pricing

Spain

Patent: 60648
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 70265
Estimated Expiration: See Plans and Pricing

Patent: 14182
Estimated Expiration: See Plans and Pricing

Patent: 55952
Estimated Expiration: See Plans and Pricing

Patent: 1612171
Estimated Expiration: See Plans and Pricing

Patent: 1815384
Estimated Expiration: See Plans and Pricing

Patent: 2003489
Estimated Expiration: See Plans and Pricing

Patent: 2134227
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OXBRYTA around the world.

Country Patent Number Title Estimated Expiration
Taiwan 202017902 Compounds and uses thereof for the modulation of hemoglobin See Plans and Pricing
Japan 2016516696 ヘモグロビンの修飾のための化合物及びその使用 See Plans and Pricing
Israel 292366 תרכובות מותמרות של בנזאלדהיד ושיטות לשימושן בהגברת החימצון ברקמות (Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation) See Plans and Pricing
Peru 20151907 COMPUESTOS Y USOS DE ESTOS PARA LA MODULACION DE LA HEMOGLOBINA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OXBRYTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2797416 122022000052 Germany See Plans and Pricing PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416 CA 2022 00032 Denmark See Plans and Pricing PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215
2797416 301191 Netherlands See Plans and Pricing PRODUCT NAME: VOXELOTOR OF EEN TAUTOMEER OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1622 20220215
2797416 PA2022517 Lithuania See Plans and Pricing PRODUCT NAME: VOKSELOTORAS ARBA TAUTOMERAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1622 20220214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Colorcon
Merck
Moodys
McKesson

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.