IDHIFA Drug Patent Profile
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When do Idhifa patents expire, and when can generic versions of Idhifa launch?
Idhifa is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and eleven patent family members in thirty-nine countries.
The generic ingredient in IDHIFA is enasidenib mesylate. One supplier is listed for this compound. Additional details are available on the enasidenib mesylate profile page.
DrugPatentWatch® Generic Entry Outlook for Idhifa
Idhifa was eligible for patent challenges on August 1, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 16, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for IDHIFA
| International Patents: | 111 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 12 |
| Patent Applications: | 93 |
| Drug Prices: | Drug price information for IDHIFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IDHIFA |
| What excipients (inactive ingredients) are in IDHIFA? | IDHIFA excipients list |
| DailyMed Link: | IDHIFA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IDHIFA
Generic Entry Date for IDHIFA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for IDHIFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Chicago | Phase 1 |
| University Health Network, Toronto | Phase 1/Phase 2 |
| AbbVie | Phase 1/Phase 2 |
Pharmacology for IDHIFA
| Drug Class | Isocitrate Dehydrogenase 2 Inhibitor |
| Mechanism of Action | Isocitrate Dehydrogenase 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IDHIFA
US Patents and Regulatory Information for IDHIFA
IDHIFA is protected by six US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of IDHIFA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting IDHIFA
Therapeutically active compounds and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
Therapeutically active compounds and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
Methods and compositions for cell-proliferation-related disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
Therapeutically active compositions and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION
Therapeutically active compounds and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Therapeutically active compounds and their methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting IDHIFA
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-002 | Aug 1, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for IDHIFA
When does loss-of-exclusivity occur for IDHIFA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0411
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 13207289
Estimated Expiration: ⤷ Try a Trial
Patent: 17265096
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014016805
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 60623
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14001793
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4114543
Estimated Expiration: ⤷ Try a Trial
Patent: 7417667
Estimated Expiration: ⤷ Try a Trial
Patent: 8912066
Estimated Expiration: ⤷ Try a Trial
Patent: 4933585
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 30962
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 140377
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180844
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20506
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 14012726
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 0187
Estimated Expiration: ⤷ Try a Trial
Patent: 1491330
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
Patent: 06608
Estimated Expiration: ⤷ Try a Trial
Patent: 84997
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 03942
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 38403
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3503
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09081
Estimated Expiration: ⤷ Try a Trial
Patent: 11895
Estimated Expiration: ⤷ Try a Trial
Patent: 15503571
Estimated Expiration: ⤷ Try a Trial
Patent: 17075193
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 5206
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 8940
Estimated Expiration: ⤷ Try a Trial
Patent: 14008350
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7096
Estimated Expiration: ⤷ Try a Trial
Patent: 2582
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1400073
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 97546
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 142098
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014501561
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 401
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201602862R
Estimated Expiration: ⤷ Try a Trial
Patent: 201403878Q
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 00743
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1405163
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1893112
Estimated Expiration: ⤷ Try a Trial
Patent: 140113712
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 75760
Estimated Expiration: ⤷ Try a Trial
Patent: 01430
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 53228
Estimated Expiration: ⤷ Try a Trial
Patent: 1329054
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1809228
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 7451
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering IDHIFA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20180844 | ⤷ Try a Trial | |
| New Zealand | 722582 | Methods of preparing 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{ [2-(trifluoromethyl)pyridin-4-yl]amino} -1,3,5-triazin-2-yl)amino]propan-2-ol | ⤷ Try a Trial |
| Taiwan | I653228 | ⤷ Try a Trial | |
| Turkey | 201809228 | ⤷ Try a Trial | |
| China | 110386922 | 治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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