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 one branded drug 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 seventy-nine patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for MITAPIVAT SULFATE

International Patents:	179
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
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
EuroBloodNet Association	Phase 2
Agios Pharmaceuticals, Inc.	Phase 4
Agios Pharmaceuticals, Inc.	Phase 2/Phase 3

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

International Patents for MITAPIVAT SULFATE

Country	Patent Number	Title	Estimated Expiration
Hungary	E063541
European Patent Office	2448582	DÉRIVÉS DE QUINOLINE-8-SULFONAMIDE AYANT UNE ACTIVITÉ ANTICANCÉREUSE (QUINOLINE-8-SULFONAMIDE DERIVATIVES HAVING AN ANTICANCER ACTIVITY)
Moldova, Republic of	3307271
Taiwan	I598337
Singapore	11202004587X	CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL) PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
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)
China	103764147

Supplementary Protection Certificates for MITAPIVAT SULFATE

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	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
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	PA2023513	Lithuania		PRODUCT NAME: MITAPIVATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC MITAPIVATO SULFATAS; REGISTRATION NO/DATE: EU/1/22/1662 20221109
2448582	19/2023	Austria		PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MITAPIVAT-SULFAT; REGISTRATION NO/DATE: EU/1/22/1662 (MITTEILUNG) 20221110

MITAPIVAT SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mitapivat Sulfate

Introduction

Mitapivat sulfate, marketed as PYRUKYND, is a significant drug developed by Agios Pharmaceuticals, targeting various hematological disorders, including pyruvate kinase (PK) deficiency, beta thalassemia, and sickle cell disease. Here, we delve into the market dynamics and financial trajectory of this promising therapeutic agent.

Clinical Development and Approval Prospects

Mitapivat sulfate has shown substantial promise in clinical trials. The ACTIVATE-T trial, which focused on regularly transfused adults with PK deficiency, demonstrated a statistically significant reduction in transfusion burden. Of the 27 patients enrolled, 37% had a ≥ 33% reduction in transfusion burden, and 22% were transfusion-free during the 24-week fixed dose period[1].

The likelihood of approval (LoA) for mitapivat sulfate has increased significantly. Following the positive results from the ACTIVATE-T trial, GlobalData's LoA score rose from 45% to 57%[1]. For beta thalassemia, the Phase III drugs have an 83% phase transition success rate (PTSR) indication benchmark, which bodes well for mitapivat sulfate's approval prospects[5].

Market Size and Growth Potential

The global pharmaceutical market, within which mitapivat sulfate operates, is substantial and growing. In 2022, the market size was estimated at USD 1,482.0 billion and is expected to grow at a CAGR of 6.12% from 2023 to 2030. This growth is driven by factors such as increasing chronic disease prevalence, a rising geriatric population, and extensive R&D investments[3].

Mitapivat sulfate is expected to capture a significant share of this growing market. Peak sales for the drug are forecasted to reach $786 million by 2026, according to GlobalData's consensus forecasts[1].

Financial Performance

Agios Pharmaceuticals has seen a steady increase in revenue from PYRUKYND (mitapivat sulfate). In the first quarter of 2024, the drug generated $8.2 million in net revenue, a 15% sequential increase from the fourth quarter of 2023. By the third quarter of 2024, this figure rose to $9.0 million, driven by increased patient demand[2][4].

The company's financial health is also robust, with cash, cash equivalents, and marketable securities totaling $714.3 million as of March 31, 2024, and $1.7 billion as of September 30, 2024[2][4].

Key Milestones and Priorities

Agios Pharmaceuticals is focused on several key milestones for mitapivat sulfate:

• Thalassemia: The company plans to file a supplemental New Drug Application (sNDA) for mitapivat in thalassemia based on positive results from the Phase 3 ENERGIZE and ENERGIZE-T clinical trials[4].
• Sickle Cell Disease: Enrollment for the Phase 3 RISE UP study of mitapivat in sickle cell disease has been completed, with topline data expected in late 2025[4].

Market Expansion and Partnerships

To enhance market reach, Agios has entered into strategic partnerships. For instance, the company has a distribution agreement with NewBridge Pharmaceuticals to commercialize PYRUKYND in the Gulf Cooperation Council (GCC) region, including Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates[4].

Competitive Landscape

The pharmaceutical market is highly competitive, with major players continually investing in R&D to develop novel therapeutics. The branded segment, which includes drugs like mitapivat sulfate, dominated the market with a 67.60% revenue share in 2022. However, the generic segment is expected to grow rapidly due to patent expiries and increasing demand for affordable medications[3].

Patient Demand and Therapeutic Impact

Mitapivat sulfate addresses significant unmet clinical needs, particularly in patients with hematological disorders. The drug's ability to reduce transfusion burden and improve anemia symptoms has been clinically meaningful, as noted by experts who participated in the Phase II and Phase III trials[1].

"Even though the Phase II DRIVE-PK trial measured efficacy through secondary endpoints, the results were clinically meaningful and would bode well for the Phase III program," - Experts interviewed by GlobalData[1].

Conclusion

Mitapivat sulfate is poised for significant market impact due to its strong clinical performance, favorable approval prospects, and growing revenue. As Agios Pharmaceuticals continues to advance through key milestones and expand its market reach, the drug is expected to play a crucial role in the treatment of various hematological disorders.

Key Takeaways

• Clinical Success: Mitapivat sulfate has demonstrated statistically significant reductions in transfusion burden in clinical trials.
• Approval Prospects: The drug's likelihood of approval has increased, with an 83% PTSR benchmark for beta thalassemia.
• Financial Growth: Revenue from PYRUKYND is increasing, with peak sales forecasted at $786 million by 2026.
• Market Expansion: Strategic partnerships are enhancing the drug's market reach, particularly in the GCC region.
• Competitive Landscape: The drug operates in a competitive market but holds a strong position due to its therapeutic impact.

FAQs

1. What is the current status of mitapivat sulfate in clinical trials? Mitapivat sulfate is currently in Phase III clinical trials for beta thalassemia and has completed enrollment for the Phase 3 RISE UP study in sickle cell disease[4][5].

2. What are the expected peak sales for mitapivat sulfate? Peak sales for mitapivat sulfate are forecasted to reach $786 million by 2026, according to GlobalData's consensus forecasts[1].

3. How has the revenue from PYRUKYND (mitapivat sulfate) been performing? Revenue from PYRUKYND has been increasing, with $8.2 million in net revenue in Q1 2024 and $9.0 million in Q3 2024, driven by increased patient demand[2][4].

4. What are the key milestones for mitapivat sulfate in the near future? Agios plans to file an sNDA for mitapivat in thalassemia and expects topline data from the Phase 3 RISE UP study in sickle cell disease in late 2025[4].

5. How is Agios expanding the market reach of PYRUKYND? Agios has entered into a distribution agreement with NewBridge Pharmaceuticals to commercialize PYRUKYND in the GCC region[4].

Sources

1. Pharmaceutical Technology: "Approval prospects for Agios' mitapivat sulphate for PK deficiency sees 12-point rise in US approval prospects."
2. Agios Investor Relations: "Agios Reports Business Highlights and First Quarter 2024 Financial Results."
3. Grand View Research: "Pharmaceutical Market Size, Share & Trends Report, 2030."
4. Agios Investor Relations: "Agios Reports Business Highlights and Third Quarter 2024 Financial Results."
5. Pharmaceutical Technology: "Mitapivat sulfate by Agios Pharmaceuticals for Beta Thalassaemia."