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 twelve 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:	112
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	12
Patent Applications:	589
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

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
Ukraine	117451	ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ І СПОСОБИ ЇХ ЗАСТОСУВАННЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Singapore	10201709187T	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Mexico	358940

Market Dynamics and Financial Trajectory for IDHIFA

Introduction to IDHIFA

IDHIFA, also known as enasidenib, is a groundbreaking cancer medication approved by the FDA for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation. This mutation is present in about 8% to 19% of the AML population[4].

Market Approval and Impact

The FDA approval of IDHIFA in August 2017 marked a significant milestone for both Celgene and Agios Pharmaceuticals, the companies involved in its development. This approval allowed Agios to transition from a clinical-stage company to one with a marketed product, and it expanded Celgene's portfolio in the oncology sector[4].

Clinical Efficacy and Safety

IDHIFA's approval was based on an open-label, single-arm Phase 1/2 study that demonstrated a complete response or complete response with partial hematologic improvement rate of 23% in patients with relapsed or refractory AML and the IDH2 mutation. However, the drug carries a box warning for a potentially fatal condition called differentiation syndrome[4].

Market Dynamics

Growing Demand for IDH Inhibitors

The market for IDH inhibitors, including IDHIFA, is expected to grow significantly due to the increasing incidence of IDH-mutated cancers such as AML and cholangiocarcinoma. The growing awareness and acceptance of IDH inhibitors among healthcare professionals are also driving this growth[1].

Competition and Pipeline

The IDH inhibitor market is niche but rapidly evolving. IDHIFA competes with other IDH inhibitors like ivosidenib (TIBSOVO) and emerging therapies such as vorasidenib and BAY1436032. These new therapies are expected to reshape the market landscape, offering new standards of care and potential market share shifts[1].

Regional Analysis

The market for IDH inhibitors, including IDHIFA, is segmented across key regions such as the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. These regions are expected to drive the growth of the IDH inhibitor market due to their advanced healthcare systems and higher adoption rates of innovative therapies[1].

Financial Performance

Revenue and Sales

IDHIFA has contributed significantly to the revenue of Agios Pharmaceuticals and Celgene. In 2020, Agios reported net product revenue from IDHIFA sales of $2.9 million in the fourth quarter, and $3.0 million in royalty revenue from global sales under the collaboration agreement with Celgene[5].

Annual Revenue Growth

For the year ended December 31, 2020, Agios reported total revenue of $203.2 million, which included $39.1 million in net product revenue from TIBSOVO (another IDH inhibitor) and $2.9 million in royalty revenue from IDHIFA. This represented a significant increase from the previous year, reflecting the growing market acceptance of these drugs[5].

Collaboration and Licensing

The financial trajectory of IDHIFA is also influenced by collaboration agreements. Agios Pharmaceuticals entered into a definitive agreement to sell its commercial, clinical, and research-stage oncology portfolio, including IDHIFA, to Servier in December 2020. This deal included the transfer of Agios' oncology portfolio, development pipeline, and research programs to Servier, further impacting the financial dynamics of IDHIFA[5].

Future Outlook

Regulatory Milestones

The future of IDHIFA and other IDH inhibitors is promising, with several regulatory milestones on the horizon. For example, vorasidenib, another IDH inhibitor, has been granted Fast Track Designation and Breakthrough Therapy Designation by the FDA and is awaiting approval for the treatment of IDH-mutant diffuse glioma[1].

Market Expansion

The anticipated launch of new IDH inhibitors is expected to expand the market, offering new treatment options for patients with IDH-mutated cancers. This expansion is likely to drive further revenue growth and market penetration for IDHIFA and other similar therapies[1].

Challenges and Limitations

Eligible Patient Population

One of the key challenges for IDH inhibitors, including IDHIFA, is the limited eligible patient population. These drugs are effective only in patients with specific genetic mutations in the IDH gene, which restricts their market potential compared to other cancer therapies[1].

Safety Concerns

IDHIFA, like other IDH inhibitors, comes with safety concerns such as the risk of differentiation syndrome, which can be potentially fatal. This requires careful patient monitoring and management, which may impact its adoption and usage[4].

Key Takeaways

• Growing Market: The IDH inhibitor market, including IDHIFA, is expected to grow significantly due to increasing incidence of IDH-mutated cancers and growing awareness among healthcare professionals.
• Financial Performance: IDHIFA has contributed to the revenue growth of Agios Pharmaceuticals and Celgene, with significant increases in net product revenue and royalty income.
• Future Outlook: The market is poised for further expansion with the anticipated launch of new IDH inhibitors, despite challenges related to the limited eligible patient population and safety concerns.
• Regulatory Milestones: Ongoing regulatory approvals and designations for new IDH inhibitors will continue to shape the market dynamics and financial trajectory of IDHIFA.

FAQs

1. What is IDHIFA used for?

   • IDHIFA (enasidenib) is used for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation.

2. Who developed IDHIFA?

   • IDHIFA was developed by Agios Pharmaceuticals in collaboration with Celgene.

3. What are the key safety concerns associated with IDHIFA?

   • IDHIFA carries a box warning for a potentially fatal condition called differentiation syndrome.

4. How has the market for IDH inhibitors, including IDHIFA, been performing?

   • The market for IDH inhibitors is expected to grow significantly due to the rising occurrence of IDH-mutated cancers and growing awareness among healthcare professionals.

5. What are the future prospects for IDHIFA and other IDH inhibitors?

   • The future outlook is promising with the anticipated launch of new IDH inhibitors, which is expected to expand the market and offer new treatment options for patients with IDH-mutated cancers.

Cited Sources:

1. GlobeNewswire: "IDH Inhibitor Market to Exhibit Significant Growth Rate During the Study Period (2020–2034) | DelveInsight"[1]
2. Royalty Pharma: "Royalty Pharma Reports Second Quarter 2020 Results"[2]
3. Cognitive Market Research: "Global Idhifa Market Report 2024 Edition, Market Size, Share, CAGR ..."[3]
4. Biopharma Dive: "Idhifa approval furthers Celgene's diversification goals"[4]
5. Agios Pharmaceuticals: "Agios Reports Fourth Quarter and Full Year 2020 Financial Results"[5]

Last updated: 2024-12-17