Details for New Drug Application (NDA): 212576
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NDA 212576 describes INQOVI, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the INQOVI profile page.
The generic ingredient in INQOVI is cedazuridine; decitabine. One supplier is listed for this compound. Additional details are available on the cedazuridine; decitabine profile page.
The generic ingredient in INQOVI is cedazuridine; decitabine. One supplier is listed for this compound. Additional details are available on the cedazuridine; decitabine profile page.
Summary for 212576
| Tradename: | INQOVI |
| Applicant: | Otsuka |
| Ingredient: | cedazuridine; decitabine |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212576
Generic Entry Date for 212576*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 212576
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212576
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INQOVI | cedazuridine; decitabine | TABLET;ORAL | 212576 | NDA | Taiho Pharmaceutical Co., Ltd. | 64842-0727 | 64842-0727-9 | 1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;35MG | ||||
| Approval Date: | Jul 7, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 7, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 7, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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, REFRACTORY ANEMIA WITH EXCESS BLASTS, AND CHRONIC MYELOMONOCYTIC LEUKEMIA [CMML]) AND INTERMEDIATE-1, INTERMEDIATE-2, AND HIGH-RISK INTERNATIONAL PROGNOSTIC SCORING SYSTEM GROUPS. | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 22, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE | ||||||||
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