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Last Updated: December 25, 2024

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IDHIFA Drug Patent Profile


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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 eleven patent family members in thirty-nine 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

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Drug patent expirations by year for IDHIFA
Drug Prices for IDHIFA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

SponsorPhase
University of ChicagoPhase 1
University Health Network, TorontoPhase 1/Phase 2
AbbViePhase 1/Phase 2

See all IDHIFA clinical trials

Pharmacology for IDHIFA

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IDHIFA is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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

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

Patent: 0411
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 13207289
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Subscribe

Patent: 17265096
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2014016805
Patent: compostos terapeuticamente ativos e seus métodos de uso
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 60623
Patent: COMPOSES THERAPEUTIQUEMENT ACTIFS ET LEURS PROCEDES D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 14001793
Patent: Compuestos derivados de 1,3,5-triazinas sustituidas y sus sales, como inhibidores de la idh2 mutante; composicion farmaceutica que los comprende; y su uso para el tratamiento del cancer.
Estimated Expiration: ⤷  Subscribe

China

Patent: 4114543
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Subscribe

Patent: 7417667
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use)
Estimated Expiration: ⤷  Subscribe

Patent: 8912066
Patent: 治疗活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Patent: 4933585
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Subscribe

Patent: 5521264
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Subscribe

Patent: 5536635
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 30962
Patent: Compuestos terapéuticamente activos y sus métodos de uso
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 140377
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0180844
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 20506
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 00743
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 14012726
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 0187
Patent: ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷  Subscribe

Patent: 1491330
Patent: ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 00743
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Patent: 06608
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Patent: 84997
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 03942
Patent: 治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 38403
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 3503
Patent: מדכאי איזוציטראט דהידרוגנאז, תכשירים המכילים אותם ושימושים בהם (Isocitrate dehydrogenase inhibitors, compositions comprising same and uses thereof)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 09081
Estimated Expiration: ⤷  Subscribe

Patent: 11895
Estimated Expiration: ⤷  Subscribe

Patent: 15503571
Patent: 治療活性化合物およびその使用方法
Estimated Expiration: ⤷  Subscribe

Patent: 17075193
Patent: 治療活性化合物およびその使用方法 (THERAPEUTICALLY ACTIVE COMPOSITIONS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 00743
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 5206
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 8940
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.)
Estimated Expiration: ⤷  Subscribe

Patent: 14008350
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 7096
Patent: Triazinyl compounds and their methods of use
Estimated Expiration: ⤷  Subscribe

Patent: 2582
Patent: Methods of preparing 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{ [2-(trifluoromethyl)pyridin-4-yl]amino} -1,3,5-triazin-2-yl)amino]propan-2-ol
Estimated Expiration: ⤷  Subscribe

Nicaragua

Patent: 1400073
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODO
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 97546
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 142098
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 014501561
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 00743
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 00743
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 401
Patent: TERAPEUTSKI AKTIVNA JEDINJENJA I POSTUPCI ZA NJIHOVU UPOTREBU (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201602862R
Patent: Therapeutically Active Compounds And Their Methods Of Use
Estimated Expiration: ⤷  Subscribe

Patent: 201403878Q
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 00743
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1405163
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1893112
Estimated Expiration: ⤷  Subscribe

Patent: 140113712
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 75760
Estimated Expiration: ⤷  Subscribe

Patent: 01430
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 53228
Estimated Expiration: ⤷  Subscribe

Patent: 1329054
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Subscribe

Turkey

Patent: 1809228
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 7451
Patent: ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ І СПОСОБИ ЇХ ЗАСТОСУВАННЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Subscribe

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
New Zealand 716226 ⤷  Subscribe
Taiwan 201932455 Therapeutically active compounds and their methods of use ⤷  Subscribe
Lithuania 2800743 ⤷  Subscribe
Taiwan I666208 ⤷  Subscribe
South Korea 20160037195 치료학적 활성 화합물 및 이의 사용방법 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

IDHIFA Market Analysis and Financial Projection Experimental

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]

More… ↓

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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.