Generic Ensacove Availability
Last updated on Apr 10, 2025.
Ensacove is a brand name of ensartinib, approved by the FDA in the following formulation(s):
ENSACOVE (ensartinib hydrochloride - capsule;oral)
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Manufacturer: XCOVERY
Approval date: December 18, 2024
Strength(s): EQ 25MG BASE [RLD], EQ 100MG BASE [RLD]
Is there a generic version of Ensacove available?
No. There is currently no therapeutically equivalent version of Ensacove available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ensacove. 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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Crystalline form of compound suppressing protein kinase activity, and application thereof
Patent 10,899,744
Issued: January 26, 2021
Inventor(s): Liang; Congxin et al.
Assignee(s): XCOVERY HOLDINGS, INC. (Palm Beach Gardens, FL)Provided are a compound as represented by structural formula (I) ({5-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-6-aminopyridazin-3-yl}-N-{4-[((3S,5R)-3,5-di methylpiperazinyl)carbonyl]phenyl}carboxamide hydrochloride) and a novel crystalline form of a hydrate or solvate of the compound. Further provided are a manufacturing method of the compound and crystalline form, a related intermediate, a pharmaceutical composition comprising the compound, an application using the compound or the crystalline form for preparing a pharmaceutical product for treating a disease, symptom, or disorder, and a therapeutic method for treating a disease, symptom, or disorder. ##STR00001##
Patent expiration dates:
- June 1, 2037✓✓
- June 1, 2037
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Kinase inhibitor compounds
Patent 8,551,995
Issued: October 8, 2013
Inventor(s): Liang; Congxin
Assignee(s): Xcovery Holding Company, LLC (West Palm Beach, FL)Pyridine and pyridazine derivatives have unexpected drug properties as inhibitors of protein kinases and are useful in treating disorders related to abnormal protein kinase activities such as cancer.
Patent expiration dates:
- February 9, 2029✓
- February 9, 2029
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Substituted pyridazine carboxamide compounds
Patent 9,126,947
Issued: September 8, 2015
Inventor(s): Liang; Congxin
Assignee(s): Xcovery Holding Company LLC (West Palm Beach, FL)The new pyridazine derivatives have unexpected drug properties as inhibitors of protein kinases especially against ALK and are useful in treating disorders related to abnormal protein kinase activities such as cancer, neurological and psychiatric diseases.
Patent expiration dates:
- November 29, 2031✓
- November 29, 2031
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Substituted pyridazinecarboxamides as kinase inhibitors
Patent 9,296,724
Issued: March 29, 2016
Inventor(s): Liang; Congxin et al.
Assignee(s): Xcovery Holding Company LLC (Palm Beach Gardens, FL)Pyridazine derivatives (e.g., Formula I) have unexpected drug properties as inhibitors of protein kinases and are useful in treating disorders related to abnormal protein kinase activities such as cancer. ##STR00001##
Patent expiration dates:
- June 18, 2029✓✓
- June 18, 2029
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:
- December 18, 2029 - NEW CHEMICAL ENTITY
More about Ensacove (ensartinib)
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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.