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PYRUKYND Drug Patent Profile

Which patents cover Pyrukynd, and what generic alternatives are available?

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

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

See drug prices for PYRUKYND

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PYRUKYND

Constraining patent/regulatory exclusivity:

11,254,652

NDA:

216196

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.

Pharmacology for PYRUKYND

Drug Class	Pyruvate Kinase Activator
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers P-Glycoprotein Inhibitors Pyruvate Kinase Activators UGT1A1 Inducers

US Patents and Regulatory Information for PYRUKYND

PYRUKYND is protected by nine US patents and two FDA Regulatory Exclusivities.

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
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes	10,632,114
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes	11,234,976
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	11,878,049
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-002	Feb 17, 2022		RX	Yes	No	11,234,976
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes	11,793,806

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

Brazil

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Morocco

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

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
Moldova, Republic of	3307271
South Korea	20170012585	치료용 화합물 및 조성물 (Therapeutic compounds and compositions)
Taiwan	I649313
Israel	276414
Portugal	2704721
Finland	C20230017
Mexico	2012000256	COMPUESTOS TERAPEUTICOS Y COMPOSICIONES. (THERAPEUTIC COMPOUNDS AND COMPOSITIONS.)

Supplementary Protection Certificates for PYRUKYND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2448582	CR 2023 00014	Denmark		PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110
2448582	CA 2023 00014	Denmark		PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110
2448582	2023C/517	Belgium		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	C202330019	Spain		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	301230	Netherlands		PRODUCT NAME: MITAPIVAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MITAPIVATSULFAAT; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582	2390014-5	Sweden		PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; REG. NO/DATE: EU/1/22/1662 20221110
2448582	23C1017	France		PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MITAPIVAT, EN PARTICULIER SULFATE DE MITAPIVAT.; REGISTRATION NO/DATE: EU/1/22/1662 20221110

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