OXBRYTA Drug Patent Profile
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Which patents cover Oxbryta, and what generic alternatives are available?
Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are ten patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and seventy-one patent family members in forty countries.
The generic ingredient in OXBRYTA is voxelotor. One supplier is listed for this compound. Additional details are available on the voxelotor profile page.
DrugPatentWatch® Generic Entry Outlook for Oxbryta
Oxbryta was eligible for patent challenges on November 25, 2023.
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.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for OXBRYTA
| International Patents: | 271 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 4 |
| Patent Applications: | 103 |
| Drug Prices: | Drug price information for OXBRYTA |
| What excipients (inactive ingredients) are in OXBRYTA? | OXBRYTA excipients list |
| DailyMed Link: | OXBRYTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| Global Blood Therapeutics | Phase 2 |
| Emory University | Phase 2 |
| Global Blood Therapeutics | Phase 4 |
Pharmacology for OXBRYTA
| Drug Class | Hemoglobin S Polymerization Inhibitor |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OXBRYTA
US Patents and Regulatory Information for OXBRYTA
OXBRYTA is protected by twelve US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OXBRYTA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzald- ehyde
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASING HEMOGLOBIN TO TREAT SICKLE CELL DISEASE BY ADMINISTERING 1500 MG OF VOXELOTOR ORALLY ONCE DAILY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR AND ANOTHER ACTIVE AGENT
Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
1:1 adducts of sickle hemoglobin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SICKLE CELL DISEASE BY ADMINISTERING VOXELOTOR, AS RECITED IN CLAIM 1
1:1 adducts of sickle hemoglobin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting OXBRYTA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 213137-001 | Nov 25, 2019 | RX | Yes | Yes | ⤷ 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 | ||||
| Global Blood Theraps | OXBRYTA | voxelotor | TABLET;ORAL | 213137-001 | Nov 25, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | ||||
| >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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 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: ⤷ Try a Trial
Patent: 0638
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 15214182
Estimated Expiration: ⤷ Try a Trial
Patent: 20207778
Estimated Expiration: ⤷ Try a Trial
Patent: 22203213
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015032160
Estimated Expiration: ⤷ Try a Trial
Patent: 2019006506
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 16564
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5431147
Estimated Expiration: ⤷ Try a Trial
Patent: 4181194
Estimated Expiration: ⤷ Try a Trial
Patent: 4181195
Estimated Expiration: ⤷ Try a Trial
Patent: 4213390
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0210388
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 24097
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8529
Estimated Expiration: ⤷ Try a Trial
Patent: 1592212
Estimated Expiration: ⤷ Try a Trial
Patent: 1791587
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
Patent: 25766
Estimated Expiration: ⤷ Try a Trial
Patent: 68745
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 53706
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3214
Estimated Expiration: ⤷ Try a Trial
Patent: 5777
Estimated Expiration: ⤷ Try a Trial
Patent: 5918
Estimated Expiration: ⤷ Try a Trial
Patent: 6014
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09681
Estimated Expiration: ⤷ Try a Trial
Patent: 17505347
Estimated Expiration: ⤷ Try a Trial
Patent: 19137699
Estimated Expiration: ⤷ Try a Trial
Patent: 21113225
Estimated Expiration: ⤷ Try a Trial
Patent: 23016994
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9995
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 1810
Estimated Expiration: ⤷ Try a Trial
Patent: 15017614
Estimated Expiration: ⤷ Try a Trial
Patent: 19004120
Estimated Expiration: ⤷ Try a Trial
Patent: 22007912
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 522
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5029
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 160179
Estimated Expiration: ⤷ Try a Trial
Patent: 201444
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 6370358
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 653
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201804139V
Estimated Expiration: ⤷ Try a Trial
Patent: 201911662Y
Estimated Expiration: ⤷ Try a Trial
Patent: 201911668V
Estimated Expiration: ⤷ Try a Trial
Patent: 201510135X
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 02208
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2345380
Estimated Expiration: ⤷ Try a Trial
Patent: 2588476
Estimated Expiration: ⤷ Try a Trial
Patent: 160118204
Patent: 2-하이드록시-6-((2-(1-이소프로필-1H-피라졸-5-일)피리딘-3-일)메톡시)벤즈알데하이드의 유리 염기의 결정성 다형체 (2--6-2-1--1H--5--3- CRYSTALLINE POLYMORPHS OF THE FREE BASE OF 2-HYDROXY-6-2-1-ISOPROPYL-1H-PYRAZOL-5-YLPYRIDIN-3-YLMETHOXYBENZALDEHYDE)
Estimated Expiration: ⤷ Try a Trial
Patent: 220002722
Patent: 2-하이드록시-6-((2-(1-이소프로필-1H-피라졸-5-일)피리딘-3-일)메톡시)벤즈알데하이드의 유리 염기의 결정성 다형체 (2--6-2-1--1H--5--3- CRYSTALLINE POLYMORPHS OF THE FREE BASE OF 2-HYDROXY-6-2-1-ISOPROPYL-1H-PYRAZOL-5-YLPYRIDIN-3-YLMETHOXYBENZALDEHYDE)
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 60648
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 70265
Estimated Expiration: ⤷ Try a Trial
Patent: 14182
Estimated Expiration: ⤷ Try a Trial
Patent: 55952
Estimated Expiration: ⤷ Try a Trial
Patent: 78983
Estimated Expiration: ⤷ Try a Trial
Patent: 99115
Estimated Expiration: ⤷ Try a Trial
Patent: 1612171
Estimated Expiration: ⤷ Try a Trial
Patent: 1815384
Estimated Expiration: ⤷ Try a Trial
Patent: 2003489
Estimated Expiration: ⤷ Try a Trial
Patent: 2134227
Estimated Expiration: ⤷ Try a Trial
Patent: 2245761
Estimated Expiration: ⤷ Try a Trial
Patent: 2332423
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014150258 | ⤷ Try a Trial | |
| European Patent Office | 3738434 | INTERMÉDIAIRES POUR OBTENIR DES COMPOSÉS DE BENZALDÉHYDE SUBSTITUÉ ET PROCÉDÉS POUR LEUR UTILISATION À AUGMENTER L'OXYGÉNATION DES TISSUS (INTERMEDIATES TO OBTAIN SUBSTITUTED BENZALDEHYDE COMPOUNDS AND METHODS FOR THEIR USE IN INCREASING TISSUE OXYGENATION) | ⤷ Try a Trial |
| Singapore | 11201507351P | COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN | ⤷ Try a Trial |
| South Africa | 201506390 | COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN | ⤷ Try a Trial |
| South Africa | 201703791 | COMPOUNDS AND USES THEREOF FOR THE MODULATION OF HEMOGLOBIN | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OXBRYTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | C202230036 | Spain | ⤷ Try a Trial | PRODUCT NAME: VOXELOTOR O UN TAUTOMERO O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1622; DATE OF AUTHORISATION: 20220214; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1622; DATE OF FIRST AUTHORISATION IN EEA: 20220214 |
| 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 | 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 | 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 |
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.
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