IDHIFA Drug Patent Profile

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 sixteen patent family members in forty 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:	116
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	12
Patent Applications:	962
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

See drug prices for IDHIFA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IDHIFA

Constraining patent/regulatory exclusivity:

9,732,062

NDA:

209606

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
AbbVie	Phase 1/Phase 2
University Health Network, Toronto	Phase 1/Phase 2

See all IDHIFA clinical trials

Pharmacology for IDHIFA

Drug Class	Isocitrate Dehydrogenase 2 Inhibitor
Mechanism of Action	Isocitrate Dehydrogenase 2 Inhibitors

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents.

This potential generic entry date is based on patent 9,732,062.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,512,107		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	9,512,107		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	10,610,125
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	9,738,625			Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,093,654		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	10,093,654		Y	Y

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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
Argentina	097237
Australia	2014295938
Australia	2018247242
Brazil	112016002287
Canada	2919382
Chile	2016000263

IDHIFA (enasidenib) market dynamics and financial trajectory: exclusivity, generic/biosimilar risk, and revenue outlook

Last updated: July 25, 2026

IDHIFA (enasidenib) is a branded oral oncology drug for relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation. Its commercial trajectory is shaped by (1) post-launch expansion into additional line settings and combinations, (2) competitive intensity from other AML targeted therapies, and (3) patent and exclusivity timing that determines when generics or “authorized” alternatives can enter. The near- to mid-term valuation case depends on survival benefit depth versus comparators, maintaining prescribing mindshare, and the practical timing of IP expiry and FDA regulatory acceptance for non-branded versions.

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What is IDHIFA (enasidenib) used for and how has prescribing evolved by line of therapy?

Answer: IDHIFA is used for IDH2-mutated relapsed or refractory AML, with approvals concentrated in specific post-chemotherapy settings and across relapsed disease after prior treatments. Uptake typically follows strong molecular testing coverage, clinician familiarity with targeted oral therapies, and patient selection based on IDH2 mutation status and relapse timing.

Indication footprint and treatment context

Key commercial drivers for AML targeted agents include:

• Molecular diagnostics availability (IDH2 testing rates in practice).
• Sequencing versus venetoclax-based regimens, FLT3 inhibitors, and other AML targeted therapies.
• Patient fitness for oral therapy and toxicity profile tolerability.
• Reimbursement based on response duration and clinically meaningful endpoints (response rates and duration of response).

Why line-of-therapy matters for sales velocity

For targeted AML drugs, early-line or combination expansion changes:

• Addressable patient pool size.
• Dose intensity and persistence (adherence and discontinuation patterns).
• Competitive displacement risk from SOC and newer targeted combinations.

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How has the AML targeted therapy competitive landscape affected IDHIFA revenue over time?

Answer: IDHIFA competes in a crowded post-relapse AML environment where venetoclax plus backbone chemotherapy, FLT3 inhibitors, and other IDH-targeted or pathway-targeted agents can re-route patient flow away from single-agent targeted approaches, compressing pricing power and reducing incremental share.

Competitive pressure channels

• Patient selection tightening: When clinicians prioritize higher-probability regimens, targeted monotherapy can lose share even if efficacy is robust in molecularly defined cohorts.
• Combination ecosystem: If guideline-facing regimens move toward combinations that include other targeted drugs, IDHIFA can face “keep-out” effects unless it gains combination approvals.
• Oral targeted mindshare: Even with convenience, AML is high-turnover. Shorter time on therapy in some cohorts reduces lifetime value per patient.

Economic consequence: pricing and persistence

The revenue impact typically shows up as:

• Lower net price realization (rebates, contracting, channel pressure).
• Lower persistence (shorter time on drug due to disease progression or switch to alternative regimens).
• Higher marketing spend to defend share in the face of newer entrants.

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When does IDHIFA lose exclusivity and what patents drive generic entry risk?

Answer: The commercial entry risk for IDHIFA is governed by Orange Book-listed drug product exclusivities and patent expirations covering the active ingredient and/or formulation and method-of-use claims. The practical generic entry date is the earliest date where an ANDA filer can obtain approval without infringing unexpired claims, typically after relevant patent expiry and any regulatory exclusivity window.

Exclusivity and patent timing: what to map for a generic scenario

A full IDHIFA risk model in the US generally needs:

• Orange Book “listed drug” patents for product/formulation and method-of-use.
• Regulatory exclusivities that can delay ANDA approval even if some patents expire.
• Lawsuit-triggered stay mechanics if Paragraph IV certifications were filed.

What investors and litigators look for

The generic launch probability is highest when:

• Remaining unexpired claims are weak or limited in scope (narrow formulation or narrow method-of-use).
• No active patent estate in the specific claim category needed to block approval.
• Settlement or adjudication creates a defined “carve-out” entry schedule.

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What is the Orange Book status of IDHIFA and how many patents cover it?

Answer: IDHIFA’s Orange Book status determines the number and categories of listed patents that can block ANDA approval. A high-level market dynamic takeaway is that the breadth of listed patents (multiple product and method-of-use families) materially increases entry friction and can delay generic revenue erosion.

Patent estate structure to assess (categories)

• Drug substance patents (active ingredient synthesis and/or composition).
• Drug product/formulation patents (polymorphs, salts, dissolution, tablet composition).
• Method-of-use patents (specific AML treatment regimens).
• Use + patient selection patents (biomarker-defined dosing or line-of-therapy specifics).

Commercial implication of patent density

• More patents across multiple categories increase odds of:
  • longer litigation tails,
  • delayed approval,
  • narrower generic designs.

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Has IDHIFA faced Paragraph IV challenges, and what settlements or litigation control launch dates?

Answer: For high-value brands, Paragraph IV litigation typically becomes the gating item that converts patent expiry uncertainty into a calendar-based launch window through court decisions or settlements. The market impact is the certainty level around “when” and “how early” generics can ship.

What a litigation-driven market shift looks like

• Filing date to decision gap can be long in US oncology.
• Settlement terms often specify:
  • earliest launch date,
  • agreed design changes,
  • exclusivity carve-outs,
  • dismissal without admission.

Revenue erosion mechanics once entry occurs

Even after “approval,” commercialization can lag due to:

• payer contracting renegotiations,
• pharmacy channel adoption,
• patient switching inertia in oncology,
• adverse event comparative tolerability perceptions.

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How strong is the patent estate for enasidenib compared with other AML IDH2 inhibitors?

Answer: Patent strength is measured by breadth (number of families), claim survivability (likelihood of valid/infringed findings), and whether independent claims overlap with generic design-around pathways. IDH2 class comparators can face parallel claim strategies if they share similar chemical scaffolds or crystalline forms.

Competitive patent mapping framework

To compare estates in practice:

• Count independent claim families per category (substance, formulation, method-of-use).
• Identify overlapping jurisdictions (US, EU, JP) that can constrain global commercialization.
• Review prior litigation outcomes if same assignee or same patent counsel appears across drugs.

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What formulations or method-of-use claims could generics realistically design around?

Answer: For oncology oral drugs, the biggest generic engineering constraints tend to be:

• specific crystalline forms or polymorph specifications,
• dissolution or bioavailability constraints,
• method-of-use claims that are tied to specific patient biomarkers and treatment settings.

Typical design-around outcomes

• A generic may use a different formulation pathway but must still clear bioequivalence.
• A generic may seek approval using labels that avoid practicing method-of-use claims, requiring careful label carve-outs.

Why label carve-outs matter commercially

If the generic’s label is narrower than the brand’s, it can:

• preserve brand share longer,
• reduce conversion of prescriptions,
• increase brand persistence through “only-appropriate” patient identification for the originator.

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How do biosimilar dynamics apply to IDHIFA, if at all?

Answer: Biosimilar frameworks apply to biologics, not to small-molecule enasidenib. IDHIFA is a small-molecule oral therapy, so the relevant entry pathway is ANDA rather than biosimilar pathways.

Practical alternative pathway categories

• ANDA with Paragraph IV challenges (small molecules).
• Authorized generics (if the brand holder or license partner licenses a generic manufacturer).
• Cross-licensing agreements that bring generic supply earlier with negotiated market terms.

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What is IDHIFA’s revenue trajectory: what financial patterns typically show up in AML targeted oncology?

Answer: In AML targeted oncology, revenue trajectories usually show:

• an early growth phase after initial launch and test coverage expansion,
• stabilization or modest growth if additional indications or line settings expand the addressable population,
• plateau or decline if competitive alternatives compress share or if high-cost therapies lose payer favor.

Revenue drivers to model

• Diagnosis growth: IDH2 mutation testing growth increases potential patient volume.
• Share dynamics: competitive displacement from other AML regimens.
• Net price: payer mix, rebate intensity, and contracting leverage.
• Patient persistence: time on therapy and discontinuation rate.
• Geographic adoption: uptake by region impacts blended sales.

Practical investor lens: ASP vs volume

For oncology drugs with defined molecular cohorts:

• volume changes usually come slower than pricing changes,
• price pressure tends to show up earlier once generics threaten or as competitors gain guideline influence.

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Where does IDHIFA sit in the valuation framework: peak sales potential and downside from generic entry?

Answer: In valuation models for branded small-molecule oncology assets, the downside case typically assumes:

• a defined earliest generic entry date under patent expiry or litigation settlement,
• rapid share loss upon launch if the generic label is equivalent,
• margin compression due to contracting and rebate normalization.

Scenario structure used in market models

• Base case: delayed entry or partial label carve-out slows share loss.
• Bear case: early entry with label parity triggers faster conversions.
• Bull case: extended exclusivity via litigation outcome or settlement pushes launch further out.

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How does IDHIFA compare commercially and clinically with other AML targeted therapies?

Answer: Commercial comparability in AML is defined by (1) molecular specificity, (2) position in treatment algorithms, and (3) evidence breadth across subgroups. IDHIFA’s competitive position depends on how clinicians weigh its response duration and tolerability versus alternative targeted drugs and venetoclax-based regimens.

Comparison dimensions that drive market share

• Response durability (duration of response and time to progression).
• Safety profile and management burden.
• Oral convenience versus IV or combination regimens.
• Ease of sequencing after SOC induction failures.

What typically changes market share fastest

• new guideline recommendations,
• payer policy revisions tied to efficacy endpoints,
• new clinical trial readouts that reframe treatment sequencing.

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What generic entry risks exist for IDHIFA and what are the likely launch barriers?

Answer: Generic entry risk is dominated by remaining unexpired patents and any litigation or settlement stays. Launch barriers are highest when remaining patents include method-of-use and formulation claims that constrain ANDA approval or compel label carve-outs.

Barriers that slow real-world revenue erosion

• Complex patent estate with multiple listed families.
• Litigation stays or injunctions that delay approval.
• Payer contracting friction and patient switching inertia.
• Brandholder “defense” through settlements or authorized supply arrangements.

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What would a post-exclusivity commercial transition look like for IDHIFA?

Answer: Once a generic can launch, the transition typically follows:

• initial limited distribution due to contracting and pharmacy adoption,
• rapid share shift if label parity exists and rebates normalize,
• brand response through price concessions and patient retention programs.

Expected near-term market behavior

• net price declines start before peak conversion if payers anticipate competition,
• volume shifts accelerate once multiple suppliers compete and rebate levels stabilize.

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Key Takeaways

• IDHIFA’s market dynamics are driven by AML treatment sequencing, IDH2 test coverage, and competitive pressure from other targeted and SOC regimens.
• The pace and magnitude of revenue erosion depend on Orange Book patent density, regulatory exclusivity, and any Paragraph IV litigation outcomes that define a credible generic launch calendar.
• Biosimilar dynamics do not apply to enasidenib; the relevant competitive pathway is ANDA-based generic entry.
• Post-exclusivity outcomes depend on label scope: label parity speeds conversion, while method-of-use label carve-outs slow it.

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FAQs

1. What factors determine when an enasidenib generic can get approved in the US?
2. How does IDH2 molecular testing adoption affect IDHIFA patient volume over time?
3. Do method-of-use patents for AML therapies delay generic launch even after drug product patents expire?
4. What commercial impact does a generic label carve-out have versus a label-parity generic?
5. How do venetoclax-based AML regimens change the competitive position of IDHIFA in relapsed settings?

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References

1. FDA. “Drugs@FDA: IDHIFA (enasidenib).” US Food and Drug Administration.
2. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” US Food and Drug Administration.
3. FDA. “Hematology Oncology Drug Development Guidance and review documents (relevant to AML endpoints).” US Food and Drug Administration.

DrugChatter Q&A for IDHIFA

Can Idhifa be used for IDH2-mutated AML?
Can idhifa treat relapsed aml?
How does Idhifa treat AML?