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Last Updated: December 26, 2024

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REZLIDHIA Drug Patent Profile


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When do Rezlidhia patents expire, and when can generic versions of Rezlidhia launch?

Rezlidhia is a drug marketed by Rigel Pharms and is included in one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and four patent family members in thirty-seven countries.

The generic ingredient in REZLIDHIA is olutasidenib. One supplier is listed for this compound. Additional details are available on the olutasidenib profile page.

DrugPatentWatch® Generic Entry Outlook for Rezlidhia

Rezlidhia will be eligible for patent challenges on December 1, 2026. 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 December 1, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for REZLIDHIA
International Patents:104
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 29
Patent Applications: 34
Drug Prices: Drug price information for REZLIDHIA
What excipients (inactive ingredients) are in REZLIDHIA?REZLIDHIA excipients list
DailyMed Link:REZLIDHIA at DailyMed
Drug patent expirations by year for REZLIDHIA
Drug Prices for REZLIDHIA

See drug prices for REZLIDHIA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REZLIDHIA
Generic Entry Date for REZLIDHIA*:
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Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
NDA:
215814
Dosage:
CAPSULE;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.

US Patents and Regulatory Information for REZLIDHIA

REZLIDHIA is protected by thirteen US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST.

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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Rigel Pharms REZLIDHIA olutasidenib CAPSULE;ORAL 215814-001 Dec 1, 2022 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

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International Patents for REZLIDHIA

When does loss-of-exclusivity occur for REZLIDHIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1976
Patent: DERIVADOS DE PIRIDIN-2(1H)-ON QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 15317322
Patent: Phenyl quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 15317327
Patent: Pyridinyl quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 15317329
Patent: Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 19283765
Patent: Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Patent: 21215141
Patent: Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2017005238
Patent: derivados de piridin-2(1h)-ona quinolinona como inibidores da isocitrato desidrogenase mutante
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 61807
Patent: DERIVES DE PHENYLQUINOLEINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DESHYDROGENASE MUTANTE (PHENYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 61811
Patent: DERIVE DE PYRIDINYLQUINOLINONE EN TANT QU'INHIBITEURS DE L'ISOCITRATE DESHYDROGENASE MUTANTE (PYRIDINYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 61817
Patent: DERIVES DE PYRIDIN-2-(1H)-ONE-QUINOLINONE A TITRE D'INHIBITEURS D'ISOCITRATE DESHYDROGENASE MUTANTE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 17000658
Patent: Derivados de piridin-2(1h)-ona quinolinona como inhibidores de isocitrato deshidrogenasa mutante
Estimated Expiration: ⤷  Subscribe

China

Patent: 7001328
Patent: 作为突变型异柠檬酸脱氢酶抑制剂的吡啶‑2(1H)‑酮喹啉酮衍生物 (Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors)
Estimated Expiration: ⤷  Subscribe

Patent: 1909130
Patent: 作为突变型异柠檬酸脱氢酶抑制剂的吡啶-2(1H)-酮喹啉酮衍生物 (Pyridine-2(1H)-one quinolinone derivatives as mutant isocitrate dehydrogenase inhibitors)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 17003241
Patent: Derivados de piridin-2(1h)-on quinolinona como inhibidores de isocitrato deshidrogenasa mutante
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0182176
Estimated Expiration: ⤷  Subscribe

Patent: 0200666
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 21149
Estimated Expiration: ⤷  Subscribe

Patent: 22865
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 94376
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 17022933
Patent: DERIVADOS DE PIRIDIN-2 (1H)-ON QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 4336
Patent: ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА КАК ИНГИБИТОРЫ МУТАНТНОЙ ИЗОЦИТРАТДЕГИДРОГЕНАЗЫ (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 8574
Patent: ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ НА ИХ ОСНОВЕ (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS THEREOF)
Estimated Expiration: ⤷  Subscribe

Patent: 1790657
Patent: ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА КАК ИНГИБИТОРЫ МУТАНТНОЙ ИЗОЦИТРАТДЕГИДРОГЕНАЗЫ
Estimated Expiration: ⤷  Subscribe

Patent: 1992489
Patent: ХИНОЛИНОНОВЫЕ ПРОИЗВОДНЫЕ ПИРИДИН-2(1H)-ОНА КАК ИНГИБИТОРЫ МУТАНТНОЙ ИЗОЦИТРАТДЕГИДРОГЕНАЗЫ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 94375
Patent: DÉRIVÉS DE PHÉNYLQUINOLÉINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE MUTANTE (PHENYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 94376
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE À TITRE D'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE MUTANTE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 01185
Patent: DÉRIVÉ DE PYRIDINYLQUINOLINONE EN TANT QU'INHIBITEURS DE L'ISOCITRATE DÉSHYDROGÉNASE MUTANTE (PYRIDINYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 33662
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 57131
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 33662
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 41460
Estimated Expiration: ⤷  Subscribe

Patent: 62424
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 1163
Patent: תולדות פירידין-2(1h)-און קווינולינון כמעכבי דהידרוגנאז מוטנט-איזוציטרט (Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors)
Estimated Expiration: ⤷  Subscribe

Patent: 2363
Patent: תולדות פירידין-2(1h)-און קווינולינון כמעכבי דהידרוגנאז מוטנט-איזוציטרט (Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors)
Estimated Expiration: ⤷  Subscribe

Patent: 2608
Patent: תולדות פירידין-2(1h)-און קווינולינון כמעכבי דהידרוגנאז מוטנט-איזוציטרט (Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 48115
Estimated Expiration: ⤷  Subscribe

Patent: 51081
Estimated Expiration: ⤷  Subscribe

Patent: 20836
Estimated Expiration: ⤷  Subscribe

Patent: 17528487
Patent: 変異イソクエン酸デヒドロゲナーゼ阻害剤としてのピリジン−２（１Ｈ）−オンキノリノン誘導体
Estimated Expiration: ⤷  Subscribe

Patent: 17528489
Patent: 変異イソクエン酸デヒドロゲナーゼ阻害剤としてのフェニルキノリノン誘導体
Estimated Expiration: ⤷  Subscribe

Patent: 17528491
Patent: 変異イソクエン酸デヒドロゲナーゼ阻害剤としてのピリジニルキノリノン誘導体
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 94376
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 6250
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Patent: 7533
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 17003404
Patent: DERIVADOS DE PIRIDIN-2(1H)-ONA QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE. (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Patent: 17003626
Patent: DERIVADOS DE PIRIDINIL QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE (MT-IDH). (PYRIDINYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Patent: 17003637
Patent: DERIVADOS DE FENIL QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE (MT-IDH). (PHENYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Patent: 19013203
Patent: DERIVADOS DE PIRIDIN-2(1H)-ONA QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE. (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 776
Patent: DERIVATI PIRIDIN-2(1H)-ON HINOLINONA KAO INHIBITORI MUTIRANE IZOCITRAT DEHIDROGENAZE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 481
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE À TITRE D'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE MUTANTE
Estimated Expiration: ⤷  Subscribe

Patent: 064
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE
Estimated Expiration: ⤷  Subscribe

Patent: 352
Patent: DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 0373
Patent: Pyridin-2(1h)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 171056
Patent: DERIVADOS DE PIRIDIN-2(1H)-ON QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 017500517
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 94376
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 94376
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Estimated Expiration: ⤷  Subscribe

Patent: 33662
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 7381129
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 184
Patent: DERIVATI PIRIDIN-2(1H)-ON HINOLINONA KAO INHIBITORI MUTIRANE IZOCITRAT DEHIDROGENAZE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 140
Patent: DERIVATI PIRIDIN-2(1H)-ON HINOLINONA KAO INHIBITORI MUTIRANE IZOCITRAT DEHIDROGENAZE (PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201702194S
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 94376
Estimated Expiration: ⤷  Subscribe

Patent: 47050
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1702127
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Patent: 1902446
Patent: PYRIDIN-2(1H)-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2209667
Estimated Expiration: ⤷  Subscribe

Patent: 170063742
Patent: 돌연변이-아이소시트레이트 탈수소효소 저해제로서의 피리딘-2(1H)-온 퀴놀린 유도체 (- -21H- PYRIDIN-21H-ONE QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 04897
Estimated Expiration: ⤷  Subscribe

Patent: 06525
Estimated Expiration: ⤷  Subscribe

Patent: 06888
Estimated Expiration: ⤷  Subscribe

Patent: 90640
Estimated Expiration: ⤷  Subscribe

Patent: 53347
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 86390
Estimated Expiration: ⤷  Subscribe

Patent: 1617335
Patent: Pyridin-2(1H)-one quinolinone derivatives as mutant-ISO citrate dehydrogenase inhibitors
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 REZLIDHIA around the world.

Country Patent Number Title Estimated Expiration
Mexico 2017003626 DERIVADOS DE PIRIDINIL QUINOLINONA COMO INHIBIDORES DE ISOCITRATO DESHIDROGENASA MUTANTE (MT-IDH). (PYRIDINYL QUINOLINONE DERIVATIVES AS MUTANT-ISOCITRATE DEHYDROGENASE INHIBITORS.) ⤷  Subscribe
Croatia P20230168 ⤷  Subscribe
Morocco 46064 DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2016044782 ⤷  Subscribe
Colombia 2017003241 Derivados de piridin-2(1h)-on quinolinona como inhibidores de isocitrato deshidrogenasa mutante ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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REZLIDHIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REZLIDHIA

Introduction to REZLIDHIA

REZLIDHIA (olutasidenib) is a significant addition to Rigel Pharmaceuticals' commercial portfolio, approved by the U.S. Food and Drug Administration (FDA) on December 1, 2022, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation[4].

Market Acceptance and Growth

Since its launch, REZLIDHIA has demonstrated impressive market acceptance. In its first full year of commercialization, REZLIDHIA generated $10.6 million in net product sales, a substantial increase from the $0.9 million in the same period of 2022. This growth is attributed to increased quantities sold as Rigel began its commercialization efforts following FDA approval[3].

Year-Over-Year Growth

In the second quarter of 2024, REZLIDHIA net product sales grew by 102% compared to the same period in 2023, reaching $5.2 million. For the six months ended June 30, 2024, REZLIDHIA sales grew by 150% compared to the same period in 2023, totaling $10.0 million[2].

Commercial Strategy and Partnerships

Rigel's commercial strategy for REZLIDHIA includes strategic alliances and collaborations to expand its therapeutic potential. For instance, Rigel has a strategic alliance with MD Anderson to advance REZLIDHIA in AML and other cancers. Additionally, Rigel is collaborating with CONNECT to evaluate REZLIDHIA in a Phase 2 clinical trial in glioma[1].

Financial Performance

The financial performance of REZLIDHIA has been a key driver of Rigel's overall revenue growth. In 2023, REZLIDHIA contributed significantly to Rigel's total net product sales of $104.3 million, which represented a 36% growth over 2022. The fourth quarter of 2023 saw REZLIDHIA net product sales of $3.9 million, up from $0.9 million in the same period of 2022[1].

Revenue Contribution

For the second quarter of 2024, REZLIDHIA net product sales were $5.2 million, and for the six months ended June 30, 2024, they were $10.0 million. These figures are part of Rigel's total revenues, which included $26.4 million from TAVALISSE and $1.9 million from GAVRETO, along with contract revenue from collaborations[2].

Pricing and Accessibility

The wholesale acquisition cost (WAC) of REZLIDHIA in the U.S. is $32,200 per month, based on the recommended dosage of 150 mg taken orally twice daily. Despite the high cost, Rigel is focused on providing access to patients, highlighting the drug's durable efficacy data, promising overall survival, and well-characterized safety profile[4].

Market Position and Competitiveness

REZLIDHIA's strong market performance is indicative of its competitive position in the AML treatment market. The drug's year-over-year growth of 107% has significantly contributed to Rigel's robust revenue growth and industry-leading gross margin of 76.12%[5].

SWOT Analysis

Rigel's strong market performance, particularly driven by REZLIDHIA, positions the company for further growth. However, challenges such as high development costs and regulatory risks are also considerations. The company's ability to leverage its commercial portfolio to fund further research and development efforts is a key strength[5].

Future Prospects and Clinical Trials

Rigel is committed to advancing REZLIDHIA through various clinical trials and collaborations. The ongoing Phase 2 clinical trial in glioma and the strategic alliance with MD Anderson are examples of efforts to expand the therapeutic potential of REZLIDHIA. These initiatives are crucial for the long-term growth and market dominance of the drug[1].

Regulatory and Market Exclusivity

REZLIDHIA benefits from orphan drug market exclusivity from the time of its marketing approval on December 1, 2022. This exclusivity provides a competitive advantage and protects Rigel's market share for a significant period[3].

Patient and Clinical Impact

REZLIDHIA offers a new and promising oral treatment option for patients with mIDH1 R/R AML, who typically experience poor clinical outcomes. The drug's durable efficacy data and well-characterized safety profile make it a valuable addition to the treatment options available for these patients[4].

Expert Insights

"REZLIDHIA is Rigel's second commercial product and is a new and promising oral treatment option for mIDH1 R/R AML patients who typically experience poor clinical outcomes," said Raul Rodriguez, Rigel's president and CEO. "With durable efficacy data, promising overall survival, and a well characterized safety profile, we are excited to bring REZLIDHIA to patients in need."[4]

Key Takeaways

  • Strong Market Acceptance: REZLIDHIA has shown significant growth since its launch, with a 150% increase in sales in the first half of 2024 compared to the same period in 2023.
  • Strategic Collaborations: Rigel's alliances with MD Anderson and CONNECT are crucial for expanding REZLIDHIA's therapeutic potential.
  • Financial Contribution: REZLIDHIA has substantially contributed to Rigel's total net product sales, driving overall revenue growth.
  • Competitive Position: The drug's strong market performance and regulatory exclusivity position it competitively in the AML treatment market.
  • Future Prospects: Ongoing clinical trials and collaborations are key to the long-term growth and market dominance of REZLIDHIA.

FAQs

What is REZLIDHIA used for?

REZLIDHIA (olutasidenib) is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation.

When was REZLIDHIA approved by the FDA?

REZLIDHIA was approved by the U.S. Food and Drug Administration (FDA) on December 1, 2022.

How much does REZLIDHIA cost?

The wholesale acquisition cost (WAC) of REZLIDHIA in the U.S. is $32,200 per month, based on the recommended dosage of 150 mg taken orally twice daily.

What are the key collaborations for REZLIDHIA?

Rigel has strategic alliances with MD Anderson to advance REZLIDHIA in AML and other cancers, and with CONNECT to evaluate REZLIDHIA in a Phase 2 clinical trial in glioma.

How has REZLIDHIA impacted Rigel's financial performance?

REZLIDHIA has significantly contributed to Rigel's total net product sales, driving a 36% growth in overall revenue in 2023 and continuing to show strong year-over-year growth in 2024.

Cited Sources:

  1. Rigel Pharmaceuticals Provides Business Update - PR Newswire, January 8, 2024.
  2. Rigel Reports Second Quarter 2024 Financial Results and Provides Business Update - PR Newswire, August 6, 2024.
  3. RIGEL PHARMACEUTICALS, INC. - SEC Filings, March 5, 2024.
  4. Rigel Announces Availability of REZLIDHIA™ (olutasidenib) in the U.S. - PR Newswire, December 22, 2022.
  5. Rigel Pharmaceuticals' SWOT analysis: stock poised for growth amid challenges - Investing.com, December 13, 2024.

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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