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IDHIFA Drug Profile
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When do Idhifa patents expire, and when can generic versions of Idhifa launch?
Idhifa is a drug marketed by Celgene Corp and is included in one NDA. There are six patents protecting this drug.
This drug has ninety-seven patent family members in thirty-seven 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.
US ANDA Litigation and Generic Entry Outlook for Idhifa
Idhifa will be eligible for patent challenges on August 1, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 97 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 51 |
| Clinical Trials: | 8 |
| Patent Applications: | 55 |
| Drug Prices: | Drug price information for IDHIFA |
| DailyMed Link: | IDHIFA at DailyMed |
Generic Entry Opportunity 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 |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | Phase 1 |
| Children's Oncology Group | Phase 2 |
Pharmacology for IDHIFA
| Drug Class | Isocitrate Dehydrogenase 2 Inhibitor |
| Mechanism of Action | Isocitrate Dehydrogenase 2 Inhibitors |
US Patents and Regulatory Information for IDHIFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-002 | Aug 1, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-001 | Aug 1, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-002 | Aug 1, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene Corp | IDHIFA | enasidenib mesylate | TABLET;ORAL | 209606-002 | Aug 1, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 722582 | Start Trial |
| Chile | 2014001793 | Start Trial |
| European Patent Office | 3027193 | Start Trial |
| Portugal | 2800743 | Start Trial |
| Ukraine | 117451 | Start Trial |
| Costa Rica | 20160054 | Start Trial |
| Japan | 2019142930 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
