Idhifa is a drug owned by Bristol Myers Squibb. It is protected by 6 US drug patents filed from 2017 to 2020 out of which none have expired yet. Idhifa's patents have been open to challenges since 01 August, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 16, 2034. Details of Idhifa'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. | |||
| US9732062 | Therapeutically active compounds and their methods of use |
Sep, 2034
(9 years from now) | Active |
| US9738625 | Therapeutically active compounds and their methods of use |
Aug, 2034
(9 years from now) | Active |
| US10093654 | Therapeutically active compounds and their methods of use |
Aug, 2034
(9 years from now) | Active |
| US9512107 | Therapeutically active compositions and their methods of use |
Jan, 2033
(8 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). | |||
| US10294215 | Therapeutically active compounds and their methods of use |
Jan, 2033
(8 years from now) | Active |
| US10610125 | Methods and compositions for cell-proliferation-related disorders |
Jun, 2030
(5 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 Idhifa's patents.
Latest Legal Activities on Idhifa's Patents
Given below is the list of recent legal activities going on the following patents of Idhifa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9512107 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Oct, 2023 | US10610125 |
| Termination or Final Written Decision | 06 Jan, 2023 | US10610125 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Nov, 2022 | US10294215 |
| Petition Requesting Trial | 23 Aug, 2022 | US10610125 |
| Petition Requesting Trial | 15 Aug, 2022 | US10610125 |
| Correspondence Address Change Critical | 03 Jun, 2022 | US10610125 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Mar, 2022 | US10093654 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Oct, 2020 | US9732062 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Oct, 2020 | US9738625 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Idhifa and ongoing litigations to help you estimate the early arrival of Idhifa generic.
Idhifa's Litigations
Idhifa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 15, 2022, against patent number US10610125. The petitioner Rigel Pharmaceuticals, Inc., challenged the validity of this patent, with Servier Pharmaceuticals LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Idhifa's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10610125 | August, 2022 |
Terminated-Settled
(06 Jan, 2023) | Servier Pharmaceuticals LLC et al. | Rigel Pharmaceuticals, Inc. |
FDA has granted some exclusivities to Idhifa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Idhifa, 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 Idhifa.
Exclusivity Information
Idhifa holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Idhifa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2022 |
| Orphan Drug Exclusivity(ODE) | Aug 01, 2024 |
| Orphan Drug Exclusivity(ODE-151) | Aug 01, 2024 |
US patents provide insights into the exclusivity only within the United States, but Idhifa 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 Idhifa's family patents as well as insights into ongoing legal events on those patents.
Idhifa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Idhifa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 16, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Idhifa Generics:
There are no approved generic versions for Idhifa as of now.
About Idhifa
Idhifa is a drug owned by Bristol Myers Squibb. It is used for treating relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. Idhifa uses Enasidenib Mesylate as an active ingredient. Idhifa was launched by Bristol Myers Squibb in 2017.
Approval Date:
Idhifa was approved by FDA for market use on 01 August, 2017.
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 Idhifa is 01 August, 2017, its NCE-1 date is estimated to be 01 August, 2021.
Active Ingredient:
Idhifa uses Enasidenib Mesylate as the active ingredient. Check out other Drugs and Companies using Enasidenib Mesylate ingredient
Treatment:
Idhifa is used for treating relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
Dosage:
Idhifa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 50MG BASE | TABLET | Prescription | ORAL |