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Last Updated: June 7, 2020

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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-three patent family members in thirty-six 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

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Summary for IDHIFA
Drug patent expirations by year for IDHIFA
Drug Prices for IDHIFA

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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.

Pharmacology for IDHIFA

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Merck
Moodys
Harvard Business School
Express Scripts

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.