Inrebic is a drug owned by Bristol-myers Squibb Co. It is protected by 5 US drug patents filed from 2019 to 2022 out of which none have expired yet. Inrebic's patents have been open to challenges since 17 August, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 24, 2039. Details of Inrebic'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. | |||
| US7528143 | Bi-aryl meta-pyrimidine inhibitors of kinases |
Nov, 2031
(7 years from now) | Active |
| US7825246 | Bi-aryl meta-pyrimidine inhibitors of kinases |
Dec, 2026
(2 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). | |||
| US11400092 | Methods of treating myeloproliferative disorders |
Sep, 2039
(14 years from now) | Active |
| US10391094 | Compositions and methods for treating myelofibrosis |
Jun, 2032
(7 years from now) | Active |
| US8138199 | Use of bi-aryl meta-pyrimidine inhibitors of kinases |
Jun, 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 Inrebic's patents.
Latest Legal Activities on Inrebic's Patents
Given below is the list of recent legal activities going on the following patents of Inrebic.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Sep, 2023 | US8138199 |
| Patent Term Extension Certificate Critical | 25 May, 2023 | US7528143 |
| Withdrawal of Application for PTE Critical | 27 Feb, 2023 | US8138199 |
| Withdrawal of Application for PTE Critical | 27 Feb, 2023 | US7825246 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2023 | US10391094 |
| Notice of Final Determination -Election Required | 23 Jan, 2023 | US7825246 |
| Notice of Final Determination -Election Required | 23 Jan, 2023 | US7528143 |
| Notice of Final Determination -Election Required | 23 Jan, 2023 | US8138199 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Aug, 2022 | US11400092 |
| Recordation of Patent Grant Mailed Critical | 02 Aug, 2022 | US11400092 |
FDA has granted several exclusivities to Inrebic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inrebic, 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 Inrebic.
Exclusivity Information
Inrebic holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Inrebic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 16, 2024 |
| Orphan Drug Exclusivity(ODE-259) | Aug 16, 2026 |
US patents provide insights into the exclusivity only within the United States, but Inrebic 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 Inrebic's family patents as well as insights into ongoing legal events on those patents.
Inrebic's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Inrebic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 24, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Inrebic Generics:
There are no approved generic versions for Inrebic as of now.
About Inrebic
Inrebic is a drug owned by Bristol-Myers Squibb Co. It is used for treating primary or secondary myelofibrosis in adult patients, monitoring thiamine levels, and administering thiamine or a thiamine equivalent. Inrebic uses Fedratinib Hydrochloride as an active ingredient. Inrebic was launched by Bristol-Myers in 2019.
Approval Date:
Inrebic was approved by FDA for market use on 16 August, 2019.
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 Inrebic is 16 August, 2019, its NCE-1 date is estimated to be 17 August, 2023.
Active Ingredient:
Inrebic uses Fedratinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fedratinib Hydrochloride ingredient
Treatment:
Inrebic is used for treating primary or secondary myelofibrosis in adult patients, monitoring thiamine levels, and administering thiamine or a thiamine equivalent.
Dosage:
Inrebic is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | CAPSULE | Prescription | ORAL |