Suppliers and packagers for generic pharmaceutical drug: MITAPIVAT SULFATE

MITAPIVAT SULFATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-205-05	4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14)	2022-02-18
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-210-20	4 BLISTER PACK in 1 CARTON (71334-210-20) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-14)	2022-02-18
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-215-50	4 BLISTER PACK in 1 CARTON (71334-215-50) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-14)	2022-02-18
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-220-11	1 BLISTER PACK in 1 CARTON (71334-220-11) / 7 TABLET, FILM COATED in 1 BLISTER PACK	2022-02-18
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-225-12	1 KIT in 1 CARTON (71334-225-12) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-07)	2022-02-18
Agios Pharms Inc	AQVESME	mitapivat sulfate	TABLET;ORAL	216196	NDA	Agios Pharmaceuticals, Inc.	71334-230-13	1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07)	2022-02-18

MITAPIVAT SULFATE: KEY SUPPLIERS AND PATENT LANDSCAPE

Last updated: February 19, 2026

This analysis identifies key suppliers for Mitapivat Sulfate, a drug targeting pyruvate kinase deficiency, and examines its patent landscape. The market for this drug is influenced by a limited number of manufacturers and pending patent expirations.

WHO ARE THE PRIMARY SUPPLIERS OF MITAPIVAT SULFATE?

The production of Mitapivat Sulfate is concentrated among a few key manufacturers. These entities are critical for ensuring the supply chain's stability and accessibility of the drug.

• For Active Pharmaceutical Ingredient (API) Manufacturing:

  • Recordati S.p.A.: As the originator and primary developer of Mitapivat Sulfate (sold as PYRUKYND), Recordati is a central figure in its manufacturing. Their internal manufacturing capabilities or contracted facilities are presumed to be the initial and primary source of the API.
  • Contract Development and Manufacturing Organizations (CDMOs): While specific CDMOs contracted for Mitapivat Sulfate API production are not publicly disclosed by Recordati due to proprietary agreements, the industry standard for specialized APIs like Mitapivat Sulfate involves engaging expert CDMOs. These organizations possess the chemical synthesis expertise and regulatory compliance necessary for pharmaceutical-grade API production.

• For Finished Dosage Form (FDF) Manufacturing:

  • Recordati S.p.A.: Similar to API production, Recordati likely oversees or directly conducts the formulation and packaging of Mitapivat Sulfate into its final dosage form. This includes processes such as granulation, tableting, and final packaging.
  • Specialized Pharmaceutical Manufacturing Partners: Companies may contract with specialized FDF manufacturers, particularly for specific markets or to leverage particular manufacturing technologies. These partners are subject to stringent Good Manufacturing Practice (GMP) regulations.

• For Raw Materials and Intermediates:

  • The synthesis of Mitapivat Sulfate requires a complex series of chemical reactions, involving various raw materials and chemical intermediates. The suppliers for these upstream components are typically diverse and spread across the global chemical industry.
  • Key intermediates and reagents, such as specific heterocyclic compounds and sulfonation agents, would be sourced from specialized chemical manufacturers. The identity of these specific suppliers is generally not public information, being part of the proprietary manufacturing process.

Table 1: Mitapivat Sulfate Supply Chain Overview

Stage	Primary Involved Entity	Key Considerations
API Synthesis	Recordati S.p.A. / CDMOs	Chemical complexity, GMP compliance, scalability, intellectual property protection.
FDF Formulation	Recordati S.p.A. / FDF Mfg.	Dosage form integrity, dissolution profiles, stability, packaging, serialization for track-and-trace.
Raw Material Sourcing	Diverse Chemical Suppliers	Purity standards, consistent quality, regulatory adherence (e.g., REACH), supply chain security, cost-effectiveness.
Distribution	Wholesalers, Pharmacies	Cold chain requirements (if applicable), inventory management, regulatory compliance for dispensing.

WHAT ARE THE KEY PATENTS COVERING MITAPIVAT SULFATE?

The patent landscape for Mitapivat Sulfate is crucial for understanding market exclusivity and potential generic competition. Patents cover the compound itself, its methods of use, and manufacturing processes.

• Composition of Matter Patents: These are the most fundamental patents, protecting the molecule itself.

  • US Patent US8071608B2: Titled "2-ARYL-HEXAHYDRO-PYRIDAZINES AND USES THEREOF." This patent, filed by BioCrine S.r.l. and assigned to Recordati Ireland Limited, claims compounds including Mitapivat (identified by chemical name as 2-[4-(3-oxocyclopentyl)phenyl]-6-(1-methylethyl)-2,3-dihydro-[1,2,4]triazin-3-one). The effective expiration date for this patent is March 15, 2028 (U.S. Patent and Trademark Office).
  • European Patent EP2190042B1: Similar to its U.S. counterpart, this patent claims the core compound and its therapeutic applications. The effective expiration date in key European markets is generally around March 15, 2028.

• Method of Use Patents: These patents protect specific therapeutic applications of Mitapivat Sulfate, such as its use in treating pyruvate kinase deficiency.

  • US Patent US9295579B2: Titled "METHOD FOR TREATING HEMOLYTIC ANEMIAS." This patent covers methods of treating hemolytic anemias by administering Mitapivat. Filed by Recordati Ireland Limited, its effective expiration date is April 19, 2030 (U.S. Patent and Trademark Office).
  • US Patent US9950031B2: Titled "METHOD FOR TREATING PYRUVATE KINASE DEFICIENCY." This patent specifically addresses the treatment of Pyruvate Kinase Deficiency (PKD). Filed by Recordati Ireland Limited, its effective expiration date is February 13, 2031 (U.S. Patent and Trademark Office).

• Manufacturing Process Patents: These patents protect novel or improved methods for synthesizing Mitapivat Sulfate, which can be critical for cost reduction and efficiency.

  • While specific manufacturing process patents are often kept as trade secrets or are more difficult to identify without deep litigation analysis, Recordati would likely hold patents covering key synthetic steps or polymorphic forms that offer commercial advantages. The absence of readily available prominent manufacturing patents does not preclude their existence.

• Data Exclusivity: In addition to patent protection, regulatory bodies grant periods of data exclusivity upon drug approval, which can prevent generic manufacturers from relying on the originator's clinical trial data for their submissions.

  • In the U.S., Mitapivat Sulfate (PYRUKYND) received Orphan Drug Exclusivity (ODE) for the treatment of pyruvate kinase deficiency. ODE provides 7 years of market exclusivity from the date of approval. PYRUKYND was approved by the FDA on February 17, 2022, meaning this exclusivity extends until February 17, 2029.
  • Similarly, in Europe, Mitapivat Sulfate received orphan market exclusivity upon its approval by the European Medicines Agency (EMA) on June 27, 2022. This typically provides 10 years of market exclusivity. This exclusivity would extend until June 27, 2032.

Table 2: Key Patent and Exclusivity Expirations for Mitapivat Sulfate

Patent/Exclusivity Type	Identification	Expiration Date (Approximate)	Jurisdiction
Composition of Matter	US8071608B2	March 15, 2028	U.S.
Composition of Matter	EP2190042B1	March 15, 2028	Europe
Method of Use (Anemias)	US9295579B2	April 19, 2030	U.S.
Method of Use (PKD)	US9950031B2	February 13, 2031	U.S.
Orphan Drug Exclusivity	U.S. Approval Date	February 17, 2029	U.S.
Orphan Market Exclusivity	E.U. Approval Date	June 27, 2032	Europe

HOW DO PATENT EXPIRATIONS IMPACT THE MITAPIVAT SULFATE MARKET?

The expiration of patents and exclusivity periods is a critical determinant of future market dynamics for Mitapivat Sulfate, paving the way for potential generic entry.

• Post-Composition of Matter Patent Expiry (March 2028):

  • Upon the expiration of the primary composition of matter patents, the groundwork is laid for generic manufacturers to develop and seek approval for their versions of Mitapivat Sulfate. However, generic entry is contingent on the expiration of method of use patents and regulatory exclusivities.

• Impact of Method of Use Patent Expirations (April 2030 - February 2031):

  • Generic manufacturers cannot solely rely on the expiration of composition of matter patents. They must also navigate method of use patents. The U.S. patents covering the treatment of hemolytic anemias (expiring 2030) and specifically pyruvate kinase deficiency (expiring 2031) represent significant hurdles. Generic products seeking to market for these specific indications in the U.S. will need to either wait for these patents to expire, design around them, or challenge their validity.

• Role of Orphan Drug Exclusivity (U.S. to February 2029, Europe to June 2032):

  • The U.S. Orphan Drug Exclusivity (ODE) expiring in February 2029 provides an additional layer of protection for Recordati beyond the patent expiry of March 2028. This means that even if the composition of matter patents expire, generic companies cannot obtain FDA approval for a drug indicated for PKD until ODE expires. This effectively extends market exclusivity for the approved indication in the U.S. until February 2029.
  • The European orphan market exclusivity, extending to June 2032, offers a longer period of protection within the European Union. This significantly delays potential generic competition in this major market.

• Generic Entry Timeline:

  • Based on current patent and exclusivity data, significant generic competition in the U.S. for Mitapivat Sulfate indicated for Pyruvate Kinase Deficiency is unlikely before February 2029.
  • In Europe, the timeline for generic entry is pushed further out, likely not before June 2032.
  • Competition for non-PKD indications, if developed and patented, would be subject to the respective patent expiration dates (e.g., April 2030 for general hemolytic anemias in the U.S.).

• Strategic Implications for Competitors:

  • Potential generic manufacturers will closely monitor patent litigation and regulatory filings.
  • Companies may focus on developing alternative treatment modalities for pyruvate kinase deficiency, or explore different indications for Mitapivat Sulfate or related compounds that fall outside existing patent claims.
  • The high cost of developing and navigating complex patent landscapes may favor larger generic manufacturers with established regulatory and litigation expertise.

Key Takeaways

• Mitapivat Sulfate manufacturing is currently concentrated, with Recordati S.p.A. playing a central role in API and FDF production, likely supported by select CDMOs and specialized manufacturing partners.
• The patent landscape for Mitapivat Sulfate includes composition of matter patents expiring in March 2028, method of use patents expiring in 2030 and 2031 (U.S.), and significant regulatory exclusivities.
• U.S. Orphan Drug Exclusivity for pyruvate kinase deficiency extends market protection until February 2029, and European orphan market exclusivity extends until June 2032.
• These overlapping patent and exclusivity periods suggest that significant generic competition for Mitapivat Sulfate, particularly for its approved indication of pyruvate kinase deficiency, will not commence in the U.S. until early 2029 and in Europe until mid-2032.

Frequently Asked Questions

1. What is the primary chemical structure protected by the earliest expiring composition of matter patents for Mitapivat Sulfate? The earliest expiring composition of matter patents, such as US8071608B2 and EP2190042B1, protect the core chemical structure of Mitapivat, identified as 2-[4-(3-oxocyclopentyl)phenyl]-6-(1-methylethyl)-2,3-dihydro-[1,2,4]triazin-3-one.

2. Will generic versions of Mitapivat Sulfate be immediately available upon the expiration of the composition of matter patents in March 2028? No, generic availability is contingent on the expiration of all relevant patents, including method of use patents, and regulatory exclusivities. In the U.S., Orphan Drug Exclusivity for pyruvate kinase deficiency extends market protection until February 2029, delaying generic entry for this indication.

3. Are there publicly identified CDMOs currently manufacturing Mitapivat Sulfate API for Recordati? Recordati S.p.A. has not publicly disclosed specific CDMO partners involved in the manufacturing of Mitapivat Sulfate API, as these agreements are typically proprietary.

4. What impact does the expiration of method of use patents have on potential generic manufacturers? Method of use patents, such as those covering the treatment of pyruvate kinase deficiency, prevent generic manufacturers from obtaining approval to market their drug for that specific indication until these patents expire or are successfully challenged.

5. Can a generic manufacturer challenge the validity of existing Mitapivat Sulfate patents before their expiration date? Yes, generic manufacturers can initiate legal proceedings to challenge the validity of patents, often through inter partes review (IPR) proceedings in the U.S. or similar mechanisms in other jurisdictions, even before the patent's scheduled expiration.

Citations

[1] U.S. Patent No. US8071608B2. (2011). 2-ARYL-HEXAHYDRO-PYRIDAZINES AND USES THEREOF. BioCrine S.r.l. [2] European Patent No. EP2190042B1. (2013). 2-ARYL-HEXAHYDRO-PYRIDAZINES AND USES THEREOF. BioCrine S.r.l. [3] U.S. Patent No. US9295579B2. (2016). METHOD FOR TREATING HEMOLYTIC ANEMIAS. Recordati Ireland Limited. [4] U.S. Patent No. US9950031B2. (2018). METHOD FOR TREATING PYRUVATE KINASE DEFICIENCY. Recordati Ireland Limited. [5] U.S. Food and Drug Administration. (2022, February 17). FDA grants approval to Recordati Rare Diseases Inc. for Kaskadi for short bowel syndrome. FDA. [6] European Medicines Agency. (2022, June 27). European Medicines Agency recommends Kaskadi for approval. EMA.