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 fifteen patent family members in thirty-eight countries.

Two suppliers are listed for this compound.

Summary for rimegepant sulfate

International Patents:	115
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rimegepant sulfate
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	11,083,724		Y
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	8,759,372		Y	Y

International Patents for rimegepant sulfate

Country	Patent Number	Title	Estimated Expiration
South Korea	101875353
Japan	6109874
Mexico	352171	SAL DE HEMISULFATO DE N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROFENIL)-6 ,7,8,9-TETRAHIDRO-5H-CICLOHEPTA[B]PIRIDIN-9-IL-4-(2-OXO-2,3-DIHID RO-1H-IMIDAZO[4,5-B]PIRIDIN-1-IL)PIPERIDINA-1-CARBOXILATO. (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT.)

Supplementary Protection Certificates for rimegepant sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	SPC/GB22/032	United Kingdom		PRODUCT NAME: RIMEGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/22/1645(FOR NI) 20220426; UK FURTHER MA ON IPSUM 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512	C202230042	Spain		PRODUCT NAME: RIMEGEPANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1645; DATE OF AUTHORISATION: 20220425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1645; DATE OF FIRST AUTHORISATION IN EEA: 20220425

Market Dynamics and Financial Trajectory for Rimegepant Sulfate

Last updated: July 28, 2025

Introduction

Rimegepant sulfate, marketed under brand names such as Nurtec ODT, represents a significant advancement in the treatment of migraine. Approved by the U.S. Food and Drug Administration (FDA) in 2020 for episodic migraines and later for preventive therapy, rimegepant belongs to the class of calcitonin gene-related peptide (CGRP) receptor antagonists. Its emergence has shifted the landscape of acute and preventive migraine management, impacting market dynamics and future financial trajectories within the global pharmaceutical sector.

Market Landscape and Competitive Positioning

The migraine therapeutics market, valued at approximately $4 billion in 2022, is characterized by rapid growth driven by increasing migraine prevalence, unmet therapeutic needs, and rising awareness. Rimegepant’s unique positioning as both an acute and preventive treatment offers a dual market opportunity, distinguishing it from competitors such as gepants like ubrogepant (Ubrelvy) and monoclonal antibodies targeting CGRP pathways (e.g., erenumab, fremanezumab).

Key competitors include:

• Ubrogepant: Approved for acute migraine, sharing a similar mechanism, but lacking preventive indications.
• CGRP monoclonal antibodies (mAbs): Offer preventive therapy but are typically administered via injection, which may affect patient adherence.
• Traditional therapies: Triptans and NSAIDs remain mainstays but have limitations concerning efficacy and safety.

This competitive landscape influences market share distribution, with early adoption favoring formulations offering flexibility, safety, and dual utility—traits inherent in rimegepant.

Market Dynamics

Growing Prevalence and Unmet Needs

Migraine affects over 1 billion worldwide, with significant socio-economic burdens, including productivity loss and healthcare costs. The rising prevalence is compounded by increased diagnosis rates and awareness campaigns. The World Health Organization classifies migraine as a leading cause of disability, underscoring the urgent need for effective therapies.

Regulatory Approvals and Reimbursement Landscape

Rimegepant's FDA approval for both acute and preventive treatment catalyzed broadened clinical usage, attracting significant interest from payers seeking versatile therapies that may reduce overall healthcare utilization. Reimbursement policies favor novel oral agents, enhancing market access and fueling sales growth.

Pharmaceutical Investment and R&D Trends

Major pharmaceutical companies, including Pfizer—owner of Nurtec ODT—continue investing in CGRP pathway research, signaling sustained interest and potential pipeline expansion. The dual indication approval has stimulated competitive innovation and incentivized development of next-generation gepants and combination therapeutics.

Pricing Strategies and Market Penetration

Rimegepant’s pricing, aligned with or slightly premium to other gepants, reflects its dual-use benefits. High efficacy, safety profile, and convenience of oral administration facilitate market penetration. Strategic pricing coupled with patient assistance programs encourages prescribing from healthcare providers.

Financial Trajectory

Sales Performance and Revenue Outlook

Pfizer reported that Nurtec ODT generated approximately $760 million globally in 2022, a substantial rise from its launch figures (~$211 million in 2021). Projected compound annual growth rate (CAGR) estimates for the next five years range between 8-12%, driven by expanding indications, geographic penetration, and increasing awareness.

Market Expansion Opportunities

• Global Market Penetration: While North America dominates, emerging markets in Europe, Asia-Pacific, and Latin America offer substantial growth potential due to rising migraine prevalence and improving healthcare infrastructure.
• Broader Indication Approvals: Future label expansions—for example, treating chronic migraine or other neurovascular disorders—could further augment revenue streams.
• Combination Therapies: Developing fixed-dose combinations with other migraine agents or analgesics offers another route for growth, optimizing patient compliance and market share.

Challenges Impacting Financial Outlook

• Patent Expiry Risks: Patent protections extending through 2031—though promising—may be challenged by generic entrants, risking revenue erosion.
• Pricing Pressures: Payers' push for cost-effective therapies may limit price increases and compress margins.
• Competitive Innovation: Advancements in mAbs and alternative therapies could diminish rimegepant's market share if they demonstrate superior efficacy or convenience.

Regulatory and Patent Landscape

Pfizer holds exclusive rights for Nurtec ODT until at least 2031. Patent litigations and biosimilar development could influence future market exclusivity. Continued clinical trials and regulatory submissions remain crucial to extending prospects.

Emerging Market Drivers

Technological innovations, such as digital health monitoring, personalizing migraine treatment, and remote prescribing, support market expansion. Moreover, reimbursement reforms favoring oral medications and outpatient management bolster rimegepant’s financial trajectory.

Concluding Market Perspective

The trajectory of rimegepant sulfate is poised for continued growth, driven by increasing migraine burden, expanding indications, and its favorable pharmacological profile. Strategic positioning, ongoing innovation, and favorable regulatory environments will shape its financial outlook over the next decade.

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Key Takeaways

• Rimegepant’s dual indication in acute and preventive migraine therapy uniquely positions it for sustained revenue growth amid intensifying competition.
• The global migraine treatment market is projected to grow at a CAGR of 8-12% over the next five years, with rimegepant benefiting from emerging markets and label expansions.
• Patent protections through 2031 provide a revenue shield, but generic competition remains a critical consideration for future earnings.
• Adoption will depend on reimbursement policies, competitive innovations, and the development of combination therapies.
• Continuous clinical trials and regulatory pursuits are essential for maintaining market relevance and financial growth.

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FAQs

1. How does rimegepant sulfate compare to other CGRP antagonists in terms of effectiveness?
Rimegepant demonstrates comparable efficacy to other gepants like ubrogepant, with advantages including dual indication for both acute and preventive migraine and oral administration, enhancing patient convenience.

2. What are the key factors influencing rimegepant’s market penetration in emerging economies?
Factors include local healthcare infrastructure, reimbursement policies, physician awareness, affordability, and regulatory approvals. Adoption is bolstered by increasing migraine prevalence and shifting preferences toward oral, outpatient therapies.

3. Will patent expiration significantly impact rimegepant’s revenue streams?
Potential patent expiration around 2031 could invite biosimilar and generic entrants, risking revenue decline. However, patent protections and ongoing innovation may extend exclusivity and sustain profitability.

4. What future indications could expand rimegepant’s market?
Potential extensions include chronic migraine, cluster headaches, or other neurovascular conditions. Regulatory approvals for these indications would further diversify revenue sources.

5. How do reimbursement policies influence the financial trajectory of rimegepant?
Reimbursement favoring oral therapies and out-of-pocket affordability directly impacts prescribing habits and sales volume. Favorable coverage accelerates market penetration and revenue growth.

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Sources

1. Pfizer. Nurtec ODT prescribing information. 2022.
2. GlobalData. Migraine therapeutics market analysis. 2022.
3. World Health Organization. Migraine prevalence statistics. 2021.
4. ClinicalTrials.gov. Rimegepant studies and pipeline developments.