Generic Pemazyre Availability
Last updated on Mar 13, 2025.
Pemazyre is a brand name of pemigatinib, approved by the FDA in the following formulation(s):
PEMAZYRE (pemigatinib - tablet;oral)
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Manufacturer: INCYTE CORP
Approval date: April 17, 2020
Strength(s): 4.5MG [RLD], 9MG [RLD], 13.5MG [RLD]
Has a generic version of Pemazyre been approved?
No. There is currently no therapeutically equivalent version of Pemazyre available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pemazyre. 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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Substituted tricyclic compounds as FGFR inhibitors
Patent 10,131,667
Issued: November 20, 2018
Inventor(s): Wu Liangxing & Zhang Colin & He Chunhong & Lu Liang & Yao Wenqing
Assignee(s): Incyte CorporationThe present invention relates to tricyclic compounds, and pharmaceutical compositions of the same, that are inhibitors of one or more FGFR enzymes and are useful in the treatment of FGFR-associated diseases such as cancer.
Patent expiration dates:
- June 12, 2033✓
- June 12, 2033
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Patent 11,466,004
Patent expiration dates:
- May 3, 2039✓
- May 3, 2039✓
- May 3, 2039✓
- May 3, 2039
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Patent 11,628,162
Patent expiration dates:
- August 30, 2040✓
- August 30, 2040✓
- August 30, 2040✓
- August 30, 2040✓
- August 30, 2040
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Substituted tricyclic compounds as FGFR inhibitors
Patent 9,611,267
Issued: April 4, 2017
Inventor(s): Wu Liangxing & Zhang Colin & He Chunhong & Lu Liang & Yao WenqingThe present invention relates to tricyclic compounds, and pharmaceutical compositions of the same, that are inhibitors of one or more FGFR enzymes and are useful in the treatment of FGFR-associated diseases such as cancer.
Patent expiration dates:
- January 30, 2035✓✓
- January 30, 2035
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:
- April 17, 2025 - NEW CHEMICAL ENTITY
- August 26, 2025 - TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT
- April 17, 2027 - INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST
- August 26, 2029 - TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT
More about Pemazyre (pemigatinib)
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- Drug class: multikinase inhibitors
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Glossary
| Term | Definition |
|---|---|
| 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.