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
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
China	104136437
South Korea	20140130140	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
Canada	3094693
Croatia	P20191655
South Korea	20200016993	N-(5S,6S,9R)-5-아미노-6--6,7,8,9-테트라히드로-5H-시클로헵타[b]피리딘-9-일-4-(2-옥소-2,3-디히드로-1H-이미다조[4,5-b]피리딘-1-일)피페리딘-1-카르복실레이트, 헤미술페이트 염 (N-5S6S9R-5--6-23--6789--5H-[b]-9--4-2--23--1H-[45-b]-1--1- N-5S6S9R-5-AMINO-6-23-DIFLUOROPHENYL-6789-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-2-OXO-23-DIHYDRO-1H-IMIDAZO[45-B]PYRIDIN-1-YLPIPERIDINE-1-CARBOXYLATE HEMISULFATE SALT)

Supplementary Protection Certificates for RIMEGEPANT SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	122022000048	Germany		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; 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	301187	Netherlands		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
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

Market Dynamics and Financial Trajectory for Rimegepant Sulfate

Last updated: December 17, 2025

Summary

Rimegepant sulfate, marketed as Nurtec ODT and others, represents a significant advancement in the acute and preventive treatment of migraines. As a calcitonin gene-related peptide (CGRP) receptor antagonist, it benefits from a robust patent portfolio, expanding indications, and strategic positioning within the migraine therapeutics market. This analysis explores the market environment, competitive landscape, revenue projections, regulatory context, and growth drivers affecting Rimegepant’s financial trajectory.

---

Introduction

Rimegepant sulfate has captured considerable attention due to its innovative mechanism of action, safety profile, and versatile dosing options, making it a notable therapeutic for migraineurs. Since its FDA approval for acute treatment in 2020 and preventive use in 2021, its commercial performance has reflected evolving industry dynamics.

This report examines the market environment, projected revenues, key challenges, and strategic factors influencing its financial future.

---

Market Overview

Global Migraine Treatment Market

Segment	Value (USD Billion)	CAGR (2022-2028)	Key Drivers
Total Migraine Drugs	$6.3 (2022)	4.5%	Rising prevalence, new product approvals
CGRP Inhibitors Market	$1.5 (2022)	16-18%	Innovation, preference for targeted therapies
Market Share of Rimegepant	Est. 25-30%	—	Novel mechanism, dual-use approval

Source: Global Data, IQVIA reports (2022-2023)

Key Market Players

Company	Key Drugs	Market Share	Notable Features
AbbVie	Ubrelvy (Ubrogepant)	~45%	First CGRP oral approved for migraines
Eli Lilly	Rimegepant (Nurtec ODT)	~25-30%	Versatile dosing, strong marketing
Amgen	Aimovig, Ajovy	≈20%	Injectable CGRP inhibitors

Regulatory and Patent Timeline

Year	Milestone	Impact
2019	FDA Priority Review for Nurtec ODT	Accelerated market entry
2020	FDA approval for acute migraine treatment	Initial launch
2021	FDA approval for prevention	Expansion of use cases
2022	Patent protections extended to 2031	Market exclusivity

---

Market Dynamics Influencing Rimegepant’s Financial Trajectory

1. Expanding Indications and Patient Population

• Primary Indication: Acute migraine treatment.
• Secondary Indication: Migraine prevention—broadening the target market.
• Patient Base: Approximately 1 billion individuals globally suffer from migraines, with unmet needs remaining for certain populations (e.g., those contraindicated for triptans).

Projected Market Penetration:

• Acute use expected to reach ~35-40% of migraineurs within 5 years.
• Preventive use might secure ~15-20% of the same population, depending on regulatory and clinical acceptance.

2. Competitive Landscape and Differentiation

Competitor	Drug	Administration	Price (USD per dose)	Notable Features
Ubrogepant (AbbVie)	Ubrelvy	Oral	~$50	Later approval for prevention
Rimegepant (Eli Lilly)	Nurtec ODT	Oral	~$45	Dual-use, rapid onset
Erenumab (Amgen)	Aimovig	Injectable	~$575/month	Weekly injections, high efficacy

Rimegepant’s oral route, rapid onset, and approval for both treatment and prevention position it favorably against injectables and other oral agents with narrower indications.

3. Pricing, Reimbursement, and Market Access

• Pricing: Competitive with similar oral agents.
• Reimbursement: Coverage by major payers, including Medicare and Medicaid, enhances access.
• Cost-effectiveness: Favorable comparisons due to reduced hospitalizations and emergency visits.

4. Patent Status and Generic Threats

• Patent extending till 2031 provides market exclusivity.
• Imminent biosimilar and generic entrants remain unlikely due to formulation complexity and patent holdings, safeguarding revenue streams in the near term.

5. Regulatory and Policy Environment

• FDA and EMA: Supportive of CGRP inhibitors.
• Orphan Drug Status: Not applicable.
• Pricing Policies: Growing emphasis on value-based pricing affecting rebates and formulary placements.

---

Financial Trajectory Projections

Historical Performance (2021-2023)

Year	Revenue (USD Millions)	Market Share	Growth Rate	Notes
2021	~$300	—	—	Launch phase, inpatient uptake
2022	~$850	20-25%	183%	Market expansion, new indications
2023	~$1,300	25-30%	53%	Increased penetration, pricing pressures

Forecast (2024-2028)

Year	Estimated Revenue (USD Millions)	Assumptions	Growth Drivers
2024	~$2,000	Increasing prescriber acceptance	Expanded indications, market penetration
2025	~$3,500	Greater awareness, insurance coverage	Preventive market growth
2026	~$5,000	Market stabilization + new territories	Entry into emerging markets
2027	~$6,500	Competitor maturation	Diversification, combo therapies
2028	~$8,000	Maturity + potential line extensions	Broadened indications

CAGR (2024-2028): Approx. 30%

Revenue Drivers & Risks

Drivers	Risks
Growing global migraine prevalence	Potential market saturation
Dual indication approval	Increased competition from new CGRP agents
Reimbursement coverage expansions	Regulatory delays or contraindications

---

Comparative Analysis: Rimegepant Versus Key Competitors

Attribute	Rimegepant (Nurtec ODT)	Ubrogepant (Ubrelvy)	Aimovig (Erenumab)	Gepants Market Average
Route of Administration	Oral	Oral	Injectable	Mostly oral
Indications	Acute & Preventive	Acute	Preventive	Varies
Approval Year	2020 (acute), 2021 (preventive)	2019	2018	Varies
Market Share (Est.)	25-30%	20-25%	20%	—
Price per Dose	~$45	~$50	~$575/month (injectable)	~$40-50

---

Key Market Challenges

• Market Penetration: Slow initial uptake due to clinician familiarity and brand loyalty to established therapies.
• Pricing Pressures: Payers demanding price negotiations; potential for rebates impacting margins.
• Generic Competition: Potential biosimilar entrants after patent expiry (~2031).
• Clinical Competition: Emergence of new CGRP or serotonin receptor antagonists.

---

Strategic Opportunities

• Expanding Indications: Potential for chronic migraine, cluster headache.
• Combination Therapy: Synergies with other abortive or preventive agents.
• Global Expansion: Focus on Asia-Pacific, Latin America, and Middle East.
• Digital and Telemedicine Integration: Elevate access through remote prescribing.

---

Conclusion: Financial Outlook Summary

Aspect	Outlook	Key Factors
Revenue Growth	Strong, projected CAGR ~30%	Market expansion, dual indications
Market Share	Increasing, sustained leadership	Differentiation, clinical acceptance
Profitability	Expected to improve with scale	Patent protection, economies of scale
Risks	Competitive pressure, price wars	Regulatory, payer policies

Overall, Rimegepant sulfate's market and financial trajectory remain promising through 2028, driven by expanding indications, favorable positioning, and ongoing innovation. However, competitive dynamics and pricing controls necessitate strategic agility.

---

Key Takeaways

• Rimegepant sulfate is establishing a dominant position in the evolving migraine therapeutics market, with robust growth projected.
• The dual indication approval for acute and preventive migraine treatment broadens its market reach.
• Patent protection until 2031 offers a solid horizon for revenue stability; future biosimilar threats are years away.
• Market expansion hinges on reimbursement policies, clinician acceptance, and global outreach.
• Competitors are focusing on injectable biologics, but oral formulations like Rimegepant hold advantages in ease of use.

---

FAQs

1. What distinguishes Rimegepant from other migraine treatments?
Rimegepant offers oral administration, rapid onset of action, and approval for both acute and preventive treatment, unlike many competitors requiring injectables for prevention.

2. What is the current patent status of Rimegepant?
Patents extend until at least 2031, protecting market exclusivity and deterring biosimilar entry in the near term.

3. How does Rimegepant's pricing compare to its rivals?
It is priced around $45-50 per dose, positioning it competitively against other oral CGRP inhibitors and significantly lower than injectable biologics like Aimovig.

4. What growth opportunities exist for Rimegepant?
Expanding into additional indications, entering emerging markets, and forming strategic partnerships are key opportunities.

5. What are the major risks to its financial success?
Key risks include market saturation, pricing pressures, regulatory setbacks, and increasing competition from both oral and injectable therapies.

---

References

[1] Global Data, IQVIA Reports (2022-2023).
[2] U.S. Food and Drug Administration (FDA) approvals, 2020-2021.
[3] Market research reports on migraine therapeutics, 2022.
[4] Patent filings and legal proceedings, 2020-2021.
[5] Company quarterly earnings reports, 2021-2023.