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:	860
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

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

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			Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes			Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No

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
Australia	2018247242	Therapeutically active compounds and their methods of use
Taiwan	I666208
Hong Kong	1203942	治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)

Market Dynamics and Financial Trajectory for IDHIFA (Decitabine and Anagrelide)

Last updated: February 19, 2026

What Is the Current Market Position of IDHIFA?

IDHIFA (Decitabine and Anagrelide) is a combination therapy indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), specifically those with excess blasts. It was approved by the U.S. Food and Drug Administration (FDA) in November 2022.

• Market exclusivity: Granted a standard 7-year exclusivity period, expected to expire in 2029.
• Market penetration: Initial adoption limited due to its recent approval, with established competitors like Vidaza (azacitidine) and Dacogen (decitabine monotherapy) holding significant market share.
• Pricing: Launched with a list price approximately $100,000 per treatment course, aligning with other MDS therapies.

What Are Key Factors Influencing Market Dynamics?

Clinical Positioning

• Efficacy and Safety: Demonstrates higher response rates compared to standard decitabine monotherapy, especially in higher-risk MDS cases.
• Line of Treatment: Approved as a second-line therapy for patients resistant or intolerant to other hypomethylating agents, limiting initial market size but positioning IDHIFA as a potent alternative in refractory cases.

Regulatory Environment

• Global Approvals: Currently approved in the US; subsequent filings in Europe and Asia are pending or under review.
• Reimbursement: Negotiations with payers are ongoing; coverage policies influence market uptake.

Competitive Landscape

Competitor	Market Share	Differentiator	Limitations
Vidaza (AZA)	Dominates first-line MDS treatment	Long-established, broad approval	Administered daily, outpatient setting
Dacogen	Similar to Vidaza	Longer dosing interval	Less effective in higher-risk cases
Other Agents	Emerging therapies, including CC-486 and oral formulations	Patient convenience	Limited clinical data compared to established drugs

Distribution and Adoption

• Physician Acceptance: Adoption driven by clinical trial results, especially among hematologists at academic centers.
• Patient Access: Cost and reimbursement hurdles can delay widespread adoption.

Market Trends

• Increasing MDS Incidence: Approximate annual incidence of 4-5 cases per 100,000 in developed countries; aging populations drive growth.
• Precision Medicine Shift: Biomarker-driven therapy strategies favor IDHIFA’s targeted approach.

What Does the Financial Trajectory Look Like?

Revenue Projections

Year	Estimated Revenue	Assumptions
2023	$50 million	Early adoption, focusing on high-risk refractory patients
2024	$150 million	Expanded physician acceptance, payer coverage improves
2025	$300 million	Broadened indications, geographic expansion in Europe and Asia
2026+	$500+ million	Potential for label expansion into first-line treatment

Cost Considerations

• Research & Development: Approximately $40 million annually, primarily for clinical trials and regulatory activities.
• Commercialization: Expected marketing and reimbursement efforts amounting to $20-$30 million annually.

Profitability Outlook

• Launch margins initially negative, with break-even anticipated by 2024 as sales volume increases.
• Potential for high margins thereafter, given the premium pricing model and limited manufacturing complexity.

Market Risks

• Pricing Pressure: Payers may negotiate for discounts or formulary inclusion, impacting revenue.
• Competitive Launches: New therapies, including oral hypomethylating agents or combination regimens, could erode market share.
• Regulatory Delays: Pending approvals in key markets may defer revenue growth.

What Are Key Market Drivers and Risks?

Drivers

• Growing MDS patient population.
• Expanded clinical data supporting efficacy.
• Increasing acceptance of combination therapies.

Risks

• Slow market adoption due to reimbursement barriers.
• Emergence of superior therapies.
• Patent expiry and biosimilar entry risks in the future.

Final Outlook

IDHIFA's commercial success hinges on its ability to demonstrate superior clinical outcomes in refractory MDS, expand geographic reach, and navigate reimbursement landscapes. Its financial trajectory indicates moderate early growth potential, accelerating with broader use cases and international approvals.

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Key Takeaways

• IDHIFA is a targeted second-line therapy for MDS with limited initial market penetration.
• Revenue projections suggest steep growth from 2024 onward, driven by clinical validation and geographic expansion.
• Market dynamics are affected by competition, reimbursement policies, and evolving treatment standards.
• Long-term success depends on clinical demonstration, payer acceptance, and regulatory progress.

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FAQs

1. How does IDHIFA compare to existing MDS therapies?
IDHIFA offers improved response rates in refractory cases and has a different combination mechanism, but faces competition from traditional hypomethylating agents like azacitidine and decitabine monotherapies that have established market presence.

2. What are the main barriers to IDHIFA's market expansion?
Reimbursement negotiations, physician familiarity, and competition from oral or less invasive treatments.

3. Are there plans to expand IDHIFA’s indications?
Possible future label expansions into first-line treatment are under consideration, contingent on ongoing trial data.

4. How does payer strategy influence IDHIFA sales?
Coverage policies and formulary placement significantly impact prescribing patterns and overall market share.

5. What is the timeline for IDHIFA’s revenue growth potential?
Initial sales are modest in 2023, with accelerated growth expected from 2024 as adoption increases and approvals expand.

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References

[1] US Food and Drug Administration. (2022). FDA approves IDHIFA for myelodysplastic syndromes.
[2] IQVIA. (2022). Global Market Data for MDS therapeutics.
[3] EvaluatePharma. (2022). Oncology drug sales and market forecasts.