Inqovi is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 4 US drug patents filed from 2020 to 2024 out of which none have expired yet. Inqovi's patents have been open to challenges since 07 July, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 24, 2041. Details of Inqovi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8268800 | Certain compounds, compositions and methods |
Aug, 2030
(5 years from now) | Active |
| US9567363 | Certain compounds, compositions and methods |
Oct, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11963971 | Combination decitabine and cedazuridine solid oral dosage forms |
Feb, 2041
(16 years from now) | Active |
| US8618075 | Certain compounds, compositions and methods |
Oct, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Inqovi's patents.
Latest Legal Activities on Inqovi's Patents
Given below is the list of recent legal activities going on the following patents of Inqovi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8618075 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9567363 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8268800 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Mar, 2024 | US8268800 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9567363 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8268800 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8618075 |
| Second letter to regulating agency to determine regulatory review period | 01 Aug, 2023 | US9567363 |
| Second letter to regulating agency to determine regulatory review period | 01 Aug, 2023 | US8268800 |
| Second letter to regulating agency to determine regulatory review period | 01 Aug, 2023 | US8618075 |
FDA has granted several exclusivities to Inqovi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inqovi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Inqovi.
Exclusivity Information
Inqovi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Inqovi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 07, 2025 |
| Orphan Drug Exclusivity(ODE-316) | Jul 07, 2027 |
US patents provide insights into the exclusivity only within the United States, but Inqovi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Inqovi's family patents as well as insights into ongoing legal events on those patents.
Inqovi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Inqovi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 24, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Inqovi Generics:
There are no approved generic versions for Inqovi as of now.
About Inqovi
Inqovi is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating patients with CDA deficiency. Inqovi uses Cedazuridine; Decitabine as an active ingredient. Inqovi was launched by Otsuka in 2020.
Approval Date:
Inqovi was approved by FDA for market use on 07 July, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Inqovi is 07 July, 2020, its NCE-1 date is estimated to be 07 July, 2024.
Active Ingredient:
Inqovi uses Cedazuridine; Decitabine as the active ingredient. Check out other Drugs and Companies using Cedazuridine; Decitabine ingredient
Treatment:
Inqovi is used for treating patients with CDA deficiency.
Dosage:
Inqovi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG;35MG | TABLET | Prescription | ORAL |