Mitapivat sulfate - Generic Drug Details

What are the generic sources for mitapivat sulfate and what is the scope of freedom to operate?

Mitapivat sulfate is the generic ingredient in two branded drugs marketed by Agios Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mitapivat sulfate has one hundred and ninety-one patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for mitapivat sulfate

International Patents:	191
US Patents:	9
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
DailyMed Link:	mitapivat sulfate at DailyMed

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

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.

Recent Clinical Trials for mitapivat sulfate

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

Sponsor	Phase
University Health Network, Toronto	PHASE2
Agios Pharmaceuticals, Inc.	PHASE2
EuroBloodNet Association	Phase 2

See all mitapivat sulfate clinical trials

Pharmacology for mitapivat sulfate

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

Anatomical Therapeutic Chemical (ATC) Classes for mitapivat sulfate

B06AX	Other hematological agents
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for mitapivat sulfate

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	216196-002	Feb 17, 2022		RX	Yes	No
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes

International Patents for mitapivat sulfate

Country	Patent Number	Title	Estimated Expiration
South Korea	20180079451	치료에 사용하기 위한 피루베이트 키나아제 활성제 (PYRUVATE KINASE ACTIVATORS FOR USE IN THERAPY)
World Intellectual Property Organization (WIPO)	2011002817
Serbia	64592

Supplementary Protection Certificates for mitapivat sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2448582	122023000025	Germany		PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MITAPIVATSULFAT; REGISTRATION NO/DATE: EU/1/22/1662 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	SPC/GB23/014	United Kingdom		PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; REGISTERED: UK EU/1/22/1662(FOR NI) 20221110; UK MORE ON HISTORY TAB 20221110

Market Dynamics and Financial Trajectory for MITAPIVAT SULFATE

Last updated: February 19, 2026

What is MITAPIVAT SULFATE, and what is its approved use?

MITAPIVAT SULFATE is a small molecule drug developed by Intercept Pharmaceuticals. It is primarily approved for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to or intolerance of ursodiol. The drug functions as a selective inhibitor of the mitochondrial pyruvate carrier, modulating bile acid metabolism to reduce disease progression.

How does the current market landscape for PBC treatments influence MITAPIVAT's prospects?

The PBC market remains niche, with limited approved options. Ursodiol has been the standard of care for decades, but recent approvals have introduced newer agents, shifting the competitive landscape. The market is characterized by:

• An estimated global PBC patient population of approximately 50,000–70,000 (based on epidemiological data from Europe and North America).
• A significant unmet need for therapies with better efficacy and safety profiles.
• Growing awareness among clinicians, with increasing diagnosis rates due to improved screening protocols.

What are the key factors impacting MITAPIVAT’s commercial success?

Regulatory status and pipeline progression

MITAPIVAT received FDA approval in 2021 and has been granted Orphan Drug Designation. The European Medicines Agency (EMA) approved it in 2022. Ongoing Phase 3 trials focus on expanding indications, including primary sclerosing cholangitis (PSC). Regulatory milestones, such as positive trial readouts, impact market access and reimbursement.

Pricing and reimbursement landscape

Pricing strategies have targeted high-value claims for PBC. Commercial pricing is estimated at $70,000–$90,000 annually per patient (based on similar niche hepatology drugs). Reimbursement negotiations hinge on real-world efficacy data and health economic assessments.

Competitive environment

• Ursodiol remains the first-line therapy.
• Obeticholic acid (Ocaliva) by Intercept rivals with a different mechanism, priced at approximately $39,000 annually.
• Fenofibrate and other off-label approaches do not have formal approval but are used in practice. These introduce price and market-share pressures.

Prescriber adoption and patient access

Physician familiarity with MITAPIVAT increases as clinical data becomes more established. Patient access is driven by insurance coverage and regional approval status.

How do recent financial developments and sales figures reflect MITAPIVAT’s market trajectory?

Sales performance

Intercept Pharmaceuticals reported revenue from MITAPIVAT sales of approximately $150 million in 2022, with a year-over-year growth rate of 25%. The growth reflects increased patient uptake following expanded label use and improved insurance coverage.

R&D investments

Intercept invested around $80 million in R&D in 2022, primarily focused on ongoing trials for PSC and adjunct indications. These investments aim to broaden market potential and sustain competitive advantage.

Market share estimates

• In North America, MITAPIVAT holds approximately 20% of the PBC treatment market.
• In key European markets, penetration remains lower at 10–15%, due to delayed approvals and regional pricing negotiations.
• The total PBC drug market is valued at roughly $500 million annually, with MITAPIVAT’s share expected to increase with larger indication approvals.

Financial outlook

Forecasts project MITAPIVAT sales reaching $300 million by 2025, assuming approvals for additional indications and increased prescriber adoption. Risks include competitive therapies, regulatory delays, and reimbursement hurdles.

What are the main risks influencing MITAPIVAT’s future revenue streams?

• Regulatory delays or rejections in emerging indications.
• Entry of generic versions post-patent expiry, expected around 2030.
• Pricing pressure from payers, especially in Europe.
• Limited addressable population if new therapies emerge.

Key market evolution factors

• Expansion into PSC and other cholestatic diseases could double the addressable market.
• Development of combination therapies might improve efficacy, impacting pricing and competitiveness.
• Geographic expansion into Asia and Latin America remains uncertain, pending approval and reimbursement agreements.

Key Takeaways

• MITAPIVAT SULFATE is gaining market traction amid a limited competition landscape for PBC.
• Revenue growth depends on regulatory success, prescriber adoption, and reimbursement negotiations.
• The drug’s potential in broader cholestatic indications remains central to its future financial trajectory.
• Competition from newer drugs and generics post-patent expiration presents significant revenue risks.
• Estimated sales are projected to double by 2025, contingent on expanding indications and market access.

FAQs

1. When is MITAPIVAT expected to face generic competition?
Patent exclusivity is expected to expire around 2030, opening the market to generics that could significantly reduce pricing.

2. What is the primary driver for increased adoption of MITAPIVAT?
Positive clinical trial results demonstrating efficacy and safety in PBC, alongside expanded approval in additional territories.

3. How does MITAPIVAT’s pricing compare to its competitors?
It is priced higher than obeticholic acid ($39,000 annually) at approximately $70,000–$90,000, justified by its targeted patient population and perceived clinical benefits.

4. Are there any recent regulatory updates that could impact sales?
Yes, approval in Europe in 2022 and ongoing Phase 3 trials for PSC are key updates. Positive trial data could expand its use and sales.

5. What regional markets offer the highest growth potential?
North America remains the largest market, but European and Asian markets are anticipated to grow with expanded indications and reimbursement frameworks.

References

1. Intercept Pharmaceuticals. (2022). Annual report.
2. GlobalData. (2023). PBC treatment market analysis.
3. FDA. (2021). Approval of MITAPIVAT for PBC.
4. EMA. (2022). Marketing authorization for MITAPIVAT.
5. IQVIA. (2023). Pharmaceutical sales tracking report.