Rimegepant sulfate - Generic Drug Details

What are the generic sources for rimegepant sulfate and what is the scope of freedom to operate?

Rimegepant sulfate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rimegepant sulfate has one hundred and six patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for rimegepant sulfate

International Patents:	106
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
What excipients (inactive ingredients) are in rimegepant sulfate?	rimegepant sulfate excipients list
DailyMed Link:	rimegepant sulfate at DailyMed

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

Constraining patent/regulatory exclusivity:

8,759,372

Dosage:

TABLET, ORALLY DISINTEGRATING;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.

Pharmacology for rimegepant sulfate

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for rimegepant sulfate

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for RIMEGEPANT SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NURTEC ODT	Orally Disintegrating Tablets	rimegepant sulfate	75 mg	212728	7	2024-02-27

US Patents and Regulatory Information for rimegepant sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	8,314,117		Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	11,083,724		Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	8,759,372		Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes

International Patents for rimegepant sulfate

Country	Patent Number	Title	Estimated Expiration
Hungary	E047050
European Patent Office	3773572	RIMEGEPANT POUR TROUBLES LIÉS AU CGRP (RIMEGEPANT FOR CGRP RELATED DISORDERS)
Lithuania	3254681
Mexico	2020009856	RIMEGEPANT PARA TRASTORNOS RELACIONADOS CON EL PEPTIDO RELACIONADO CON EL GEN PARA CALCITONINA (CGRP). (RIMEGEPANT FOR CGRP RELATED DISORDERS.)
Japan	2015511581	Ｎ−（５Ｓ，６Ｓ，９Ｒ）−５−アミノ−６−（２，３−ジフルオロフェニル）−６，７，８，９−テトラヒドロ−５Ｈ−シクロヘプタ［ｂ］ピリジン−９−イル−４−（２−オキソ−２，３−ジヒドロ−１Ｈ−イミダゾ［４，５−ｂ］ピリジン−１−イル）ピペリジン−１−カルボキシレート塩
Australia	2010306954	CGRP receptor antagonists
Eurasian Patent Organization	201270561	АНТАГОНИСТЫ РЕЦЕПТОРА CGRP

Supplementary Protection Certificates for rimegepant sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	CA 2022 00036	Denmark		PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	PA2022516	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	C02488512/01	Switzerland		PRODUCT NAME: RIMEGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69035 18.10.2023
2488512	22C1044	France		PRODUCT NAME: RIMEGEPANT OU UN SEL ACCEPTABLE SUR LE PLAN PHARMACEUTIQUE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	301187	Netherlands		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426

Rimegepant sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rimegepant Sulfate

Introduction to Rimegepant Sulfate

Rimegepant sulfate, marketed as Nurtec ODT, is a groundbreaking medication in the treatment of migraines. It is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for both the acute and preventive treatment of migraine attacks with or without aura in adults[1][3][4].

Mechanism of Action

Rimegepant works by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. This mechanism targets a root cause of migraines, providing fast pain relief, significant pain reduction, and a return to normal function, with effects lasting up to 48 hours in some patients[1].

Market Approval and Regulatory Status

Rimegepant was approved by the U.S. Food and Drug Administration (FDA) in February 2020 for the acute treatment of migraine and in May 2021 for the preventive treatment of episodic migraine. It is currently under review by the European Medicines Agency and other regulatory authorities outside the U.S.[1].

Commercialization and Collaboration

Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc. have entered into a strategic commercialization arrangement for rimegepant outside the United States. Under this agreement, Biohaven will continue to commercialize Nurtec ODT in the U.S., while Pfizer will commercialize rimegepant in all regions outside the U.S. Pfizer also gains rights to zavegepant, another CGRP receptor antagonist, for global commercialization outside the U.S.[1].

Financial Terms of the Collaboration

The financial terms include an upfront payment of $500 million from Pfizer to Biohaven, consisting of $150 million in cash and $350 million in the purchase of Biohaven equity at a 25% market premium. Biohaven is also eligible to receive up to $740 million in milestones and tiered double-digit royalties on ex-U.S. net sales[1].

Market Performance and Revenue

Since its launch, Nurtec ODT has become the #1 prescribed migraine treatment in its class in the U.S., with a cumulative launch to date of U.S. net revenue of approximately $336 million and over one million prescriptions[1].

Cost-Effectiveness and Economic Value

Studies have shown that rimegepant is cost-effective for the acute treatment of migraine in adults, particularly those who have inadequate symptom relief after taking triptans or for whom triptans are contraindicated or not tolerated. A cost-utility analysis in the UK found that rimegepant resulted in an incremental cost-utility ratio of £10,309 per quality-adjusted life year (QALY) gained compared to best supportive care, which is within the cost-effectiveness threshold[2].

Expanding Indications and Pipeline

Rimegepant is under development for various other indications, including psoriasis, cluster headache, chronic rhinosinusitis, and Huntington disease. It is also being studied for the treatment of refractory trigeminal neuralgia and temporomandibular disorder (TMD)[3][4].

Phase Transition Success Rate and Likelihood of Approval

For its indication in chronic rhinosinusitis, rimegepant is currently in Phase III clinical trials. According to GlobalData, Phase III drugs for rhinosinusitis have a 75% phase transition success rate, indicating a high likelihood of approval[4].

Market Growth and Trends

The global migraine drugs market is projected to grow at a CAGR of 11.9% from 2024 to 2030, driven by advancements in drug development, including the approval of CGRP antagonists like rimegepant and atogepant. The high consumer base and unmet need for effective migraine treatments are also driving market growth[5].

Competitive Landscape

Rimegepant competes in a market that includes other CGRP receptor antagonists such as ubrogepant and atogepant. However, its unique oral formulation and dual indication for both acute and preventive treatment set it apart. The collaboration with Pfizer enhances its global reach and commercial potential[1][5].

Challenges and Risks

Despite its promising market dynamics, the success of rimegepant is subject to various risks, including regulatory decisions, competitive developments, and the impact of COVID-19 on Pfizer’s business operations. The satisfaction or waiver of conditions to closing the transaction with Pfizer and the overall success of the collaboration are also critical factors[1].

Key Takeaways

• Approval and Indications: Rimegepant is approved for acute and preventive treatment of migraines and is under review for other indications.
• Commercialization: Biohaven and Pfizer have a strategic collaboration for global commercialization outside the U.S.
• Financial Performance: Significant revenue and milestones are expected, with tiered royalties and upfront payments.
• Cost-Effectiveness: Rimegepant is cost-effective compared to best supportive care.
• Market Growth: The migraine drugs market is growing, driven by advancements in CGRP antagonists.
• Competitive Landscape: Rimegepant competes with other CGRP antagonists but has a unique market position.

FAQs

What is the mechanism of action of rimegepant?

Rimegepant works by reversibly blocking CGRP receptors, inhibiting the biologic cascade that results in a migraine attack.

What are the approved indications for rimegepant in the U.S.?

Rimegepant is approved for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults.

What is the financial arrangement between Biohaven and Pfizer for rimegepant?

Biohaven will receive an upfront payment of $500 million, up to $740 million in milestones, and tiered double-digit royalties on ex-U.S. net sales.

Is rimegepant cost-effective for migraine treatment?

Yes, studies have shown that rimegepant is cost-effective for the acute treatment of migraine in adults, particularly those who have inadequate symptom relief after taking triptans.

What other indications is rimegepant being developed for?

Rimegepant is under development for psoriasis, cluster headache, chronic rhinosinusitis, Huntington disease, and other conditions.

What is the projected growth rate of the global migraine drugs market?

The global migraine drugs market is projected to grow at a CAGR of 11.9% from 2024 to 2030.

Sources

1. Biohaven and Pfizer Enter Strategic Collaboration for the Commercialization of Rimegepant Outside the United States. Pfizer.
2. Cost-effectiveness of rimegepant oral lyophilisate compared to best supportive care for the acute treatment of migraine in adults. PubMed.
3. Rimegepant sulfate (Nurtec, Vydura). GlobalData.
4. Rimegepant sulfate ODT by Pfizer for Rhinosinusitis: Likelihood of Approval. Pharmaceutical Technology.
5. Migraine Drugs Market Size, Share & Trends Report, 2030. Grand View Research.