Generic Xospata Availability
Last updated on Dec 12, 2024.
Xospata is a brand name of gilteritinib, approved by the FDA in the following formulation(s):
XOSPATA (gilteritinib fumarate - tablet;oral)
Has a generic version of Xospata been approved?
No. There is currently no therapeutically equivalent version of Xospata available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xospata. 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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Stable pharmaceutical composition for oral administration
Patent 10,786,500
Issued: September 29, 2020
Inventor(s): Miyazaki Masakazu & Ishiba Ryohei & Takaishi Yuki & Uejo Fumiaki
Assignee(s): ASTELLAS PHARMA INC.Provided is a stable pharmaceutical composition for oral administration comprising 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (hereinafter referred to as compound A) or a pharmaceutically acceptable salt thereof, wherein the generation of related substances during storage is inhibited. In the stable pharmaceutical composition for oral administration, the proportion of crystals of compound A or a pharmaceutically acceptable salt thereof is 60% or more with respect to the total amount of compound A or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Patent 11,938,130
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Patent 11,938,131
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Patent 11,938,132
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Patent 11,938,133
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Patent 11,944,620
Patent expiration dates:
- July 1, 2036✓
- July 1, 2036
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Diamino heterocyclic carboxamide compound
Patent 8,969,336
Issued: March 3, 2015
Inventor(s): Shimada Itsuro & Kurosawa Kazuo & Matsuya Takahiro & Iikubo Kazuhiko & Kondoh Yutaka & Kamikawa Akio & Tomiyama Hiroshi & Iwai YoshinoriProvided is a compound useful as an inhibitor against the kinase activity of EML4-ALK fusion protein.
Patent expiration dates:
- November 28, 2032✓✓
- November 28, 2032
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Diamino heterocyclic carboxamide compound
Patent 9,487,491
Issued: November 8, 2016
Inventor(s): Shimada Itsuro & Kurosawa Kazuo & Matsuya Takahiro & Iikubo Kazuhiko & Kondoh Yutaka & Kamikawa Akio & Tomiyama Hiroshi & Iwai YoshinoriProvided is a compound useful as an inhibitor against the kinase activity of EML4-ALK fusion protein. As a result of intensive and extensive studies on compounds having inhibitory activity against the kinase activity of EML4-ALK fusion protein, the present inventors found that the diamino heterocyclic carboxamide compounds of the present invention had inhibitory activity against the kinase activity of EML4-ALK fusion protein. By this finding, the present invention was completed. The compounds of the present invention can be used as a pharmaceutical composition for preventing and/or treating cancer, such as lung cancer, non-small cell lung cancer, and small cell lung cancer.
Patent expiration dates:
- July 28, 2030✓
- July 28, 2030
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:
- November 28, 2025 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WHO HAVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A FMS-LIKE TYROSINE KINASE 3 (FLT3) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
More about Xospata (gilteritinib)
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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.
