Generic Inqovi Availability
Last updated on May 7, 2025.
Inqovi is a brand name of cedazuridine/decitabine, approved by the FDA in the following formulation(s):
INQOVI (cedazuridine; decitabine - tablet;oral)
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Manufacturer: TAIHO ONCOLOGY
Approval date: July 7, 2020
Strength(s): 100MG;35MG [RLD]
Is there a generic version of Inqovi available?
No. There is currently no therapeutically equivalent version of Inqovi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Inqovi. 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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Combination decitabine and cedazuridine solid oral dosage forms
Patent 11,963,971
Issued: April 23, 2024
Inventor(s): Oganesian; Aram et al.
Assignee(s): Otsuka Pharmaceutical Co., Ltd. (Tokyo, JP)Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m.sup.2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m.sup.2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Patent expiration dates:
- February 24, 2041✓
- February 24, 2041
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2′-deoxy-2′,2′-difluorotetrahydrouridines with high purity and methods of making the same
Patent 12,195,496
Issued: January 14, 2025
Inventor(s): Zuend; Gemma et al.
Assignee(s): Otsuka Pharmaceutical Co., Ltd. (Tokyo, JP)The invention relates to methods of synthesizing 2′-deoxy-2′,2′-difluorotetrahydrouridine with increased purity and uniform particle size distribution. In particular, methods of the invention include crystallization and isolation procedures rendering synthetic reaction intermediates. The invention further includes compositions comprising the final compound in highly pure form, including lower number of impurities and lower levels of individual and total impurities.
Patent expiration dates:
- October 7, 2040✓
- October 7, 2040
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Combination decitabine and cedazuridine solid oral dosage forms
Patent 12,239,653
Issued: March 4, 2025
Inventor(s): Oganesian; Aram et al.
Assignee(s): Taiho Pharmaceutical Co., Ltd. (Tokyo, JP)Embodiments of the present invention provide solid oral dosage forms that upon daily administration to a subject provide plasma levels of decitabine with a 5-day AUC for decitabine that is equivalent to the 5-day AUC for a daily IV dose of decitabine of 20 mg/m.sup.2 administered as a one hour (1 h) infusion. Also provided according to embodiments of the present invention are solid oral dosage forms wherein upon daily administration to a subject provides a pharmacodynamic effect that is equivalent to the pharmacodynamic effect for a daily intravenous dose of decitabine of 20 mg/m.sup.2 administered as a one hour (1 h) infusion. Also provided are methods of treatment using a solid oral dosage form according to an embodiment of the invention.
Patent expiration dates:
- February 24, 2041✓
- February 24, 2041✓
- February 24, 2041
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Certain compounds, compositions and methods
Patent 8,268,800
Issued: September 18, 2012
Inventor(s): Hamilton Gregory S. & Tsukamoto Takashi & Ferraris Dana V. & Duvall Bridget & Lapidus Rena
Assignee(s): Eisai Inc.The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.
Patent expiration dates:
- August 22, 2030✓✓
- August 22, 2030✓✓
- August 22, 2030✓✓
- August 22, 2030✓✓
- August 22, 2030
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Certain compounds, compositions and methods
Patent 8,618,075
Issued: December 31, 2013
Inventor(s): Hamilton Gregory S. & Tsukamoto Takashi & Ferraris Dana V. & Duvall Bridget & Lapidus Rena
Assignee(s): Eisai Inc.The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.
Patent expiration dates:
- October 16, 2028✓
- October 16, 2028✓
- October 16, 2028
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Certain compounds, compositions and methods
Patent 9,567,363
Issued: February 14, 2017
Inventor(s): Hamilton Gregory S. & Tsukamoto Takashi & Ferraris Dana V. & Duvall Bridget & Lapidus Rena
Assignee(s): OTSUKA PHARMACEUTICAL CO., LTD.The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.
Patent expiration dates:
- October 16, 2028✓
- October 16, 2028
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:
- July 7, 2025 - NEW CHEMICAL ENTITY
- July 7, 2027 - TREATMENT OF ADULT PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS), INCLUDING PREVIOUSLY TREATED AND UNTREATED, DE NOVO AND SECONDARY MDS WITH THE FOLLOWING FRENCH-AMERICAN-BRITISH SUBTYPES (REFRACTORY ANEMIA, REFRACTORY ANEMIA WITH RINGED SIDEROBLASTS, REF
More about Inqovi (cedazuridine / decitabine)
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- During pregnancy
- FDA approval history
- Drug class: antineoplastic combinations
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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.
