PYRUKYND Drug Patent Profile
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When do Pyrukynd patents expire, and when can generic versions of Pyrukynd launch?
Pyrukynd is a drug marketed by Agios Pharms Inc and is included in one NDA. There are nine patents protecting this drug.
This drug has one hundred and seventy-nine patent family members in forty-five countries.
The generic ingredient in PYRUKYND is mitapivat sulfate. One supplier is listed for this compound. Additional details are available on the mitapivat sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Pyrukynd
Pyrukynd will be eligible for patent challenges on February 17, 2026. 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 November 21, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for PYRUKYND
| International Patents: | 179 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Drug Prices: | Drug price information for PYRUKYND |
| What excipients (inactive ingredients) are in PYRUKYND? | PYRUKYND excipients list |
| DailyMed Link: | PYRUKYND at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PYRUKYND
*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.
Pharmacology for PYRUKYND
US Patents and Regulatory Information for PYRUKYND
PYRUKYND is protected by nine US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PYRUKYND is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 PYRUKYND
Pyruvate kinase activators for use in therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Methods of using pyruvate kinase activators
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY BY ADMINISTERING A DAILY DOSE OF 10MG TO 100MG
Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfon- amide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS
Pyruvate kinase activators for use in therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Pyruvate kinase activators for use in therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Pyruvate kinase activators for use in therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PYRUKYND
TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Exclusivity Expiration: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-003 | Feb 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-003 | Feb 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-003 | Feb 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Agios Pharms Inc | PYRUKYND | mitapivat sulfate | TABLET;ORAL | 216196-003 | Feb 17, 2022 | 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 |
International Patents for PYRUKYND
When does loss-of-exclusivity occur for PYRUKYND?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 18373122
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷ Sign Up
Patent: 24200724
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020010185
Patent: formas cristalinas de n-(4-(4- (ciclopropilmetil)piperazina-1-carbonil)fenil)quinolina-8- sulfonamida
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 81945
Patent: FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLEINE-8-SULFONAMIDE (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL)PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1372920
Patent: N-(4-(4-(环丙基甲基)哌嗪-1-羰基)苯基)喹啉-8-磺酰胺的结晶形式 (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 7551030
Patent: N-(4-(4-(环丙基甲基)哌嗪-1-羰基)苯基)喹啉-8-磺酰胺的结晶形式
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0230931
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2091277
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ N-(4-(4-(ЦИКЛОПРОПИЛМЕТИЛ)ПИПЕРАЗИН-1-КАРБОНИЛ)ФЕНИЛ)ХИНОЛИН-8-СУЛЬФОНАМИДА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 13919
Patent: FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMÉTHYL) PIPÉRAZINE-1-CARBONYL)PHÉNYL)QUINOLÉINE-8-SULFONAMIDE (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 85904
Patent: FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMÉTHYL) PIPÉRAZINE-1-CARBONYL)PHÉNYL)QUINOLÉINE-8-SULFONAMIDE (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 63264
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4488
Patent: צורות גבישיות של n-(4-(4-(ציקלופרופילמתיל)פיפראזין-1-קרבוניל)פניל)קווינולין-8-סולפונאמיד (Crystalline forms of n-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide)
Estimated Expiration: ⤷ Sign Up
Patent: 5343
Patent: צורות גבישיות של n-(4-(4-(ציקלופרופילמתיל)פיפראזין-1-קרבוניל)פניל)קווינולין-8-סולפונאמיד (Crystalline forms of n-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 75130
Estimated Expiration: ⤷ Sign Up
Patent: 21504338
Patent: Ｎ−（４−（４−（シクロプロピルメチル）ピペラジン−１−カルボニル）フェニル）キノリン−８−スルホンアミドの結晶性形態
Estimated Expiration: ⤷ Sign Up
Patent: 23093762
Patent: Ｎ－（４－（４－（シクロプロピルメチル）ピペラジン－１－カルボニル）フェニル）キノリン－８－スルホンアミドの結晶性形態 (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL)PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20005348
Patent: FORMAS CRISTALINAS DE LA N-(4-(4-(CICLOPROPILMETIL)PIPERAZIN-1-CAR BONIL)FENIL)QUINOLIN-8-SULFONAMIDA. (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE.)
Estimated Expiration: ⤷ Sign Up
Patent: 22009998
Patent: FORMAS CRISTALINAS DE LA N-(4-(4-(CICLOPROPILMETIL)PIPERAZIN-1- CARBONIL)FENIL)QUINOLIN-8-SULFONAMIDA. (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE.)
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 805
Patent: FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMÉTHYL) PIPÉRAZINE-1-CARBONYL)PHÉNYL)QUINOLÉINE-8-SULFONAMIDE
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 020550644
Patent: CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL)PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 13919
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 592
Patent: KRISTALNE FORME N-(4-(4-(CIKLOPROPILMETIL)PIPERAZIN-1-KARBONIL)FENIL) HINOLIN-8-SULFONAMIDA (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202004587X
Patent: CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 13919
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 200090787
Patent: N-퀴놀린-8-술폰아미드의 결정 형태
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 59764
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 08108
Estimated Expiration: ⤷ Sign Up
Patent: 1930289
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷ Sign Up
Patent: 2334115
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 7502
Patent: КРИСТАЛІЧНІ ФОРМИ N-(4-(4-(ЦИКЛОПРОПІЛМЕТИЛ)ПІПЕРАЗИН-1-КАРБОНІЛ)ФЕНІЛ)ХІНОЛІН-8-СУЛЬФОНАМІДУ (CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE)
Estimated Expiration: ⤷ Sign Up
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 PYRUKYND around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1253727 | 使用丙酮酸激酶激活劑的方法 (METHODS OF USING PYRUVATE KINASE ACTIVATORS) | ⤷ Sign Up |
| France | 23C1017 | ⤷ Sign Up | |
| Nicaragua | 201200003 | COMPUESTOS TERAPÉUTICOS Y COMPOSICIONES | ⤷ Sign Up |
| Japan | 2021155455 | ピルビン酸キナーゼ活性化因子を使用する方法 (METHODS OF USING PYRUVATE KINASE ACTIVATORS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PYRUKYND
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2448582 | C202330019 | Spain | ⤷ Sign Up | PRODUCT NAME: MITAPIVAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR SULFATO DE MITAPIVAT; NATIONAL AUTHORISATION NUMBER: EU/1/22/1662; DATE OF AUTHORISATION: 20221109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1662; DATE OF FIRST AUTHORISATION IN EEA: 20221109 |
| 2448582 | LUC00306 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110 |
| 2448582 | 2390014-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; REG. NO/DATE: EU/1/22/1662 20221110 |
| 2448582 | CR 2023 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110 |
| >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.
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