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Last Updated: December 23, 2024

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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
Drug patent expirations by year for PYRUKYND
Drug Prices for PYRUKYND

See drug prices for PYRUKYND

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PYRUKYND
Generic Entry Date for PYRUKYND*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

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 ⤷  Subscribe.

This potential generic entry date is based on patent 11,254,652.

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

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes 10,632,114 ⤷  Subscribe ⤷  Subscribe
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes 11,234,976 ⤷  Subscribe ⤷  Subscribe
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-001 Feb 17, 2022 RX Yes No 11,878,049 ⤷  Subscribe ⤷  Subscribe
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-002 Feb 17, 2022 RX Yes No 11,234,976 ⤷  Subscribe ⤷  Subscribe
>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: ⤷  Subscribe

Patent: 24200724
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2020010185
Patent: formas cristalinas de n-(4-(4- (ciclopropilmetil)piperazina-1-carbonil)fenil)quinolina-8- sulfonamida
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Croatia

Patent: 0230931
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 13919
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 2091277
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ N-(4-(4-(ЦИКЛОПРОПИЛМЕТИЛ)ПИПЕРАЗИН-1-КАРБОНИЛ)ФЕНИЛ)ХИНОЛИН-8-СУЛЬФОНАМИДА
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Finland

Patent: 13919
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 63264
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Japan

Patent: 75130
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Lithuania

Patent: 13919
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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: ⤷  Subscribe

Moldova, Republic of

Patent: 13919
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 805
Patent: FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMÉTHYL) PIPÉRAZINE-1-CARBONYL)PHÉNYL)QUINOLÉINE-8-SULFONAMIDE
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 020550644
Patent: CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL)PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 13919
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 13919
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

Singapore

Patent: 202004587X
Patent: CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 13919
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 200090787
Patent: N-퀴놀린-8-술폰아미드의 결정 형태
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 59764
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 08108
Estimated Expiration: ⤷  Subscribe

Patent: 1930289
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷  Subscribe

Patent: 2334115
Patent: Crystalline forms of N-(4-(4-(cyclopropylmethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Estimated Expiration: ⤷  Subscribe

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: ⤷  Subscribe

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
Hungary E063541 ⤷  Subscribe
Moldova, Republic of 3307271 ⤷  Subscribe
Singapore 11202004587X CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE ⤷  Subscribe
Canada 3081945 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) ⤷  Subscribe
China 103764147 ⤷  Subscribe
Canada 2944788 COMPOSES, ET COMPOSITIONS ASSOCIEES, QUI MODULENT LA PYRUVATE KINASE M2, ET METHODES DE FABRICATION ASSOCIEES (COMPOUNDS, AND COMPOSITIONS THEREOF, WHICH MODULATE PYRUVATE KINASE M2, AND METHODS OF MAKING SAME) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PYRUKYND

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2448582 CR 2023 00014 Denmark ⤷  Subscribe PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110
2448582 CA 2023 00014 Denmark ⤷  Subscribe PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110
2448582 2023C/517 Belgium ⤷  Subscribe PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE DE MITAPIVAT; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110
2448582 23C1017 France ⤷  Subscribe PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MITAPIVAT, EN PARTICULIER SULFATE DE MITAPIVAT.; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582 301230 Netherlands ⤷  Subscribe PRODUCT NAME: MITAPIVAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MITAPIVATSULFAAT; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582 PA2023513 Lithuania ⤷  Subscribe PRODUCT NAME: MITAPIVATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC MITAPIVATO SULFATAS; REGISTRATION NO/DATE: EU/1/22/1662 20221109
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

PYRUKYND Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PYRUKYND

Introduction to PYRUKYND

PYRUKYND (mitapivat) is a groundbreaking drug developed by Agios Pharmaceuticals, marking a significant milestone in the treatment of genetically defined diseases. It is the first and only disease-modifying therapy approved for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare and debilitating condition[4].

Regulatory Approvals and Global Reach

PYRUKYND received FDA approval in the U.S. on February 17, 2022, for the treatment of hemolytic anemia in adults with PK deficiency. Additionally, it has received marketing authorization in the EU and Great Britain, expanding its global reach[1].

Revenue Performance

Quarterly and Annual Revenue

  • In the fourth quarter of 2022, PYRUKYND generated $4.3 million in net U.S. product revenue, with a total of $11.7 million for the full year 2022[1].
  • By the second quarter of 2024, net revenue increased to $8.6 million, showing a 5% sequential increase from Q1 2024[2].
  • In the third quarter of 2024, the net revenue further increased to $9.0 million, a 4% increase from the second quarter of 2024 and a 22% year-over-year increase[3][5].

Patient Enrollment and Therapy Uptake

  • As of the fourth quarter of 2022, 105 unique patients had completed prescription enrollment forms, with 78 patients on therapy, representing a 39% increase over the third quarter[1].
  • By the second quarter of 2024, 201 unique patients had completed prescription enrollment forms, with 128 patients on therapy, indicating continued growth[2].
  • In the third quarter of 2024, the number of unique patients increased to 211, with 127 patients on therapy[3].

Clinical Developments and Pipeline

Thalassemia

  • Agios has made significant progress in the thalassemia space, with positive topline data from the Phase 3 ENERGIZE and ENERGIZE-T studies. These studies have met primary and key secondary endpoints in both non-transfusion-dependent and transfusion-dependent thalassemia, positioning mitapivat as a potential first-in-class therapy for all thalassemia subtypes[2][3].

Sickle Cell Disease

  • Enrollment in the Phase 3 RISE UP study of mitapivat in sickle cell disease has been completed, with topline data expected in late 2025. This study involves over 200 patients worldwide[3].

Pediatric PK Deficiency

  • Agios has also completed enrollment in the Phase 3 ACTIVATE-Kids study for pediatric PK deficiency, further expanding the potential indications for PYRUKYND[2].

Lower-Risk Myelodysplastic Syndromes (LR-MDS)

  • The company has commenced enrollment in the Phase 2b study of tebapivat in LR-MDS and has been granted FDA Orphan Drug Designation for this indication[3].

Financial Trajectory

Cash Position and Liquidity

  • As of December 31, 2022, Agios had $1.1 billion in cash, cash equivalents, and marketable securities. By June 30, 2024, this figure had decreased to $645.3 million, but was significantly bolstered by payments from Royalty Pharma and Servier, bringing the total to $1.7 billion as of September 30, 2024[1][2][3].

Research and Development Expenses

  • R&D expenses increased to $77.4 million in the second quarter of 2024 from $68.9 million in the same period of 2023. However, in the third quarter of 2024, R&D expenses decreased to $72.5 million compared to the third quarter of 2023, primarily due to the absence of a one-time upfront payment recorded in the prior year[2][3].

Net Loss and Cost Structure

  • The net loss for the second quarter of 2024 was $96.1 million, an increase from $83.8 million in the same period of 2023. The cost of sales and SG&A expenses also rose, reflecting the ongoing investment in clinical trials and commercial activities[2].

Market Impact and Growth Potential

Market Expansion

  • The positive clinical data and potential approvals in additional indications such as thalassemia and sickle cell disease are expected to significantly expand the market potential for PYRUKYND. The drug's broad efficacy in various subtypes of thalassemia could make it a first-in-class therapy, driving substantial market growth[2][3].

Competitive Landscape

  • The approval and success of PYRUKYND are expected to drive growth in the global metabolism drugs market, which is anticipated to benefit from increasing regulatory approvals of innovative therapies[4].

Key Takeaways

  • Revenue Growth: PYRUKYND has shown steady revenue growth, with a 22% year-over-year increase in the third quarter of 2024.
  • Clinical Milestones: Positive data from Phase 3 studies in thalassemia and completed enrollment in sickle cell disease and pediatric PK deficiency studies position PYRUKYND for potential additional approvals.
  • Financial Strength: Agios maintains a strong cash position, enabling the company to support future launches and pipeline expansion.
  • Market Potential: The drug's potential in multiple indications, including thalassemia and sickle cell disease, suggests significant market expansion opportunities.

FAQs

Q: What is PYRUKYND and what is it used for?

A: PYRUKYND (mitapivat) is the first and only disease-modifying therapy approved for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

Q: What are the recent revenue figures for PYRUKYND?

A: In the third quarter of 2024, PYRUKYND generated $9.0 million in net revenue, a 4% increase from the second quarter of 2024 and a 22% year-over-year increase.

Q: What are the key clinical developments for PYRUKYND?

A: Positive topline data from Phase 3 studies in thalassemia, completed enrollment in the Phase 3 RISE UP study for sickle cell disease, and enrollment completion in the Phase 3 ACTIVATE-Kids study for pediatric PK deficiency are significant clinical milestones.

Q: How strong is Agios' financial position?

A: As of September 30, 2024, Agios had $1.7 billion in cash, cash equivalents, and marketable securities, providing a robust financial foundation for future activities.

Q: What is the market potential for PYRUKYND?

A: With potential approvals in additional indications such as thalassemia and sickle cell disease, PYRUKYND is poised for significant market expansion, making it a potential first-in-class therapy for various subtypes of these diseases.

Sources

  1. Agios Reports Fourth Quarter and Full Year 2022 Financial Results - Agios Investor Relations
  2. Agios Reports Business Highlights and Second Quarter 2024 Financial Results - Stock Titan
  3. Agios Reports Business Highlights and Third Quarter 2024 Financial Results - GlobeNewswire
  4. Metabolism Drugs Market Size, Trends and Forecast to 2030 - Coherent Market Insights
  5. Earnings call: Agios Pharmaceuticals reports Q3 2024 financials - Investing.com

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