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REZLIDHIA Drug Patent Profile

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

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

See drug prices for REZLIDHIA

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

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.

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.

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	11,497,743
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	10,532,047			Y
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	11,013,733
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes	11,723,905		Y

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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.)
Croatia	P20230168
Morocco	46064	DÉRIVÉS DE PYRIDIN-2-(1H)-ONE-QUINOLINONE EN TANT QU'INHIBITEURS D'ISOCITRATE DÉSHYDROGÉNASE
World Intellectual Property Organization (WIPO)	2016044782

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.