Generic Pyrukynd Availability
Last updated on Apr 10, 2024.
Pyrukynd is a brand name of mitapivat, approved by the FDA in the following formulation(s):
PYRUKYND (mitapivat sulfate - tablet;oral)
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Manufacturer: AGIOS PHARMS INC
Approval date: February 17, 2022
Strength(s): EQ 5MG BASE [RLD], EQ 20MG BASE [RLD], EQ 50MG BASE [RLD]
Has a generic version of Pyrukynd been approved?
No. There is currently no therapeutically equivalent version of Pyrukynd available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pyrukynd. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pyruvate kinase activators for use in therapy
Patent 10,632,114
Issued: April 28, 2020
Inventor(s): Su Shin-San Michael & Dang Lenny
Assignee(s): Agios Pharmaceuticals, Inc.Described herein are methods for using compounds that activate pyruvate kinase.
Patent expiration dates:
- May 3, 2032✓
- May 3, 2032
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Methods of using pyruvate kinase activators
Patent 11,234,976
Issued: February 1, 2022
Inventor(s): Agresta Samuel V. & Chen Yue & Cohen Marvin B. & Dang Lenny & Kung Charles & Merica Elizabeth A. & Silver Bruce A. & Yang Hua
Assignee(s): Agios Pharmaceuticals, Inc.Described herein are methods for using compounds that activate pyruvate kinase.
Patent expiration dates:
- October 11, 2038✓
- October 11, 2038
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Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide
Patent 11,254,652
Issued: February 22, 2022
Inventor(s): Sizemore Jacob P. & Guo Liting & Mirmehrabi Mahmoud & Su Yeqing
Assignee(s): Agios Pharmaceuticals, Inc.Provided herein are amorphous and crystalline hemisulfate salt forms of the formula (I). Also provided are pharmaceutical compositions comprising the amorphous and crystalline hemisulfate salt forms, methods for their manufacture, and uses thereof for treating conditions associated with pyruvate kinase such as e.g., pyruvate kinase deficiency.
Patent expiration dates:
- November 21, 2038✓✓
- November 21, 2038
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Patent 11,793,806
Patent expiration dates:
- April 12, 2033✓
- April 12, 2033
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Patent 11,878,049
Patent expiration dates:
- July 31, 2041✓
- July 31, 2041
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Pyruvate kinase activators for use in therapy
Patent 9,193,701
Issued: November 24, 2015
Inventor(s): Su Shin-San M.
Assignee(s): AGIOS PHARMACEUTICALS, INCDescribed herein are methods for using compounds that activate pyruvate kinase.
Patent expiration dates:
- October 26, 2032✓
- October 26, 2032
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Pyruvate kinase activators for use in therapy
Patent 9,682,080
Issued: June 20, 2017
Inventor(s): Su Shin-San Michael
Assignee(s): AGIOS PHARMACEUTICALS, INCDescribed herein are methods for using compounds that activate pyruvate kinase.
Patent expiration dates:
- May 3, 2032✓
- May 3, 2032
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Pyruvate kinase activators for use in therapy
Patent 9,980,961
Issued: May 29, 2018
Inventor(s): Su Shin-San Michael & Dang Lenny
Assignee(s): AGIOS PHARMACEUTICALS, INC.Described herein are methods for using compounds that activate pyruvate kinase.
Patent expiration dates:
- May 3, 2032✓
- May 3, 2032
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Patent RE49582
Patent expiration dates:
- February 24, 2031✓✓
- February 24, 2031
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- February 17, 2027 - NEW CHEMICAL ENTITY
- February 17, 2029 - TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
More about Pyrukynd (mitapivat)
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- Drug class: miscellaneous metabolic agents
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.