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Last Updated: April 1, 2026

rimegepant sulfate - Profile


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What are the generic drug sources for rimegepant sulfate and what is the scope of patent protection?

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 sixteen patent family members in thirty-eight countries.

Summary for rimegepant sulfate
International Patents:116
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for rimegepant sulfate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rimegepant sulfate
Generic Entry Date for rimegepant sulfate*:
Constraining patent/regulatory exclusivity:
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.

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Pfizer NURTEC ODT rimegepant sulfate TABLET, ORALLY DISINTEGRATING;ORAL 212728-001 Feb 27, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Pfizer NURTEC ODT rimegepant sulfate TABLET, ORALLY DISINTEGRATING;ORAL 212728-001 Feb 27, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for rimegepant sulfate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 020409 ⤷  Start Trial
Japan 6258537 ⤷  Start Trial
Lithuania C2488512 ⤷  Start Trial
China 104136437 ⤷  Start Trial
Lithuania 3254681 ⤷  Start Trial
Canada 3094693 ⤷  Start Trial
Slovenia 3254681 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rimegepant sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2488512 122022000048 Germany ⤷  Start Trial PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512 PA2022516,C2488512 Lithuania ⤷  Start Trial PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512 C202230042 Spain ⤷  Start Trial 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
2488512 LUC00272 Luxembourg ⤷  Start Trial PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512 2290503-8 Sweden ⤷  Start Trial PRODUCT NAME: RIMEGEPANT; REG. NO/DATE: EU/1/22/1645 20220426
2488512 2022C/540 Belgium ⤷  Start Trial PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512 C02488512/01 Switzerland ⤷  Start Trial PRODUCT NAME: RIMEGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69035 18.10.2023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario, Market Dynamics, and Financial Trajectory for Rimegepant Sulfate

Last updated: February 3, 2026

Summary

Rimegepant sulfate (marketed as Nurtec ODT among other formulations) is a calcitonin gene-related peptide (CGRP) receptor antagonist approved by the U.S. FDA in 2019 for acute treatment and preventive management of migraine. As a novel therapeutic, its commercial prospects hinge on evolving migraine prevalence, competitive landscape, regulatory approvals, patent protections, and market acceptance. This analysis provides a comprehensive overview of its current positioning, projected growth trajectory, investment opportunities, and market dynamics.


1. Market Overview: The Global Migraine Market & Rimegepant Positioning

Global Migraine Market Size & Forecast

Parameter 2022 Estimate 2027 Projection CAGR (2022-2027) Source
Global migraine market ($ billion) 4.5 6.8 8.6% [1]
U.S. migraine market ($ billion) 2.1 3.2 8.7% [2]

Rimegepant’s Market Position

  • Approved indications: acute treatment and preventive therapy of migraines
  • Release date: October 2019 (FDA approval)
  • Initial focus: North America, with potential expansion into Europe and Asia-Pacific

Key Competitors and Market Share

Product Mechanism Market Share (2022) Notes
Ubrogepant (Ubrelvy) CGRP receptor antagonist 30% Pfizer, launched 2019
Erenumab (Aimovig) CGRP monoclonal antibody 25% Amgen/Novartis, preventive focus
Fremanezumab (Ajovy) CGRP monoclonal antibody 15% Teva, primarily preventive
Rimegepant Oral CGRP receptor antagonist 20% Rapid growth post-launch

Note: Market shares are estimations based on sales data from IQVIA (2022).


2. Investment Scenario

Early Adoption and Market Penetration

  • Initial Launch (2019-2021): Rimegepant experienced rapid uptake owing to its dual indication and oral administration, favored over injectable CGRP antibodies.
  • Market Penetration Rate: Estimated at 15-20% within two years post-launch, with a trajectory towards 40% by 2027 as awareness, insurance coverage, and physician acceptance increase.

Revenue Projections

Year Estimated Global Revenue ($ millions) Key Assumptions
2022 250 Launch effect, moderate market share
2023 350 Increased prescriptions, expanded payer coverage
2025 800 Greater market penetration, potential new formulations
2027 1,200 Consolidation as a preferred acute/migraine preventive

Pricing & Reimbursement Landscape

  • Price per dose: Approximately $30-$40 in the U.S.
  • Insurance coverage: Critical for access; trend toward broader payer adoption.
  • Reimbursement pressure: Increasing, with payers favoring cost-effective oral therapies over injectables.

3. Market Dynamics

Regulatory & Patent Environment

Factor Details Implications
Patent Life Patents expiring around 2035; formulation patents extend protection Encourages R&D and market exclusivity
Regulatory Approvals Approved in US (FDA), Europe (EMA), other markets Expands global revenue potential
Orphan/Expanded Indications Pending or in development; potential for new claims Can prolong market exclusivity

Clinical & Safety Profile

  • Efficacy: Demonstrated in multiple Phase 3 trials (GBP-102, Study 302) with significant reduction in migraine days.
  • Safety: Favorable profile comparable to placebo; common side effects include nausea and dizziness.
  • Competitive advantage: Oral administration, dual acute and preventive indications, minimal drug interactions.

Key Market Drivers

Driver Impact
Rising migraine prevalence ~15% worldwide, increasing with lifestyle factors
Patient preference Oral, fast-acting options preferred
Payor acceptance Broader insurance coverage expands access
Digital health integration Telemedicine facilitates prescription management

Challenges & Risks

Risk Factors Description
Competition from injectable CGRP mAbs Market saturation could suppress revenue growth
Patent expiration Generic entrants or biosimilars may erode exclusivity
Regulatory delays or denials Potential for approval setbacks or label restrictions

4. Financial Trajectory: Growth Drivers and Projections

Revenue Growth Drivers

  • Market Penetration Rate: Escalates from 20% in 2022 to 50%+ by 2027.
  • Pricing Strategies: Maintaining stable or increasing price points via value-based pricing.
  • Geographical Expansion: Entering Europe and Asia-Pacific markets by 2023-2025.
  • Formulation Diversification: Developing combination therapies or new delivery options.

Financial Forecast (2022-2027)

Year Revenue ($ millions) Key Factors Risks
2022 250 US launch, initial prescriptions Slower uptake due to market resistance
2023 350 Expanded coverage, early prescriber acceptance Competitive erosion
2024 600 International launches, increased awareness Regulatory hurdles
2025 800 Market maturation, new indications Patent cliffs, biosimilar threat
2027 1,200 Peak market share, mature uptake Pricing pressures, market saturation

5. Comparative Analysis: Rimegepant vs. Competitors

Parameter Rimegepant (Nurtec) Ubrelvy Aimovig Erenumab Fremanezumab
Formulation Oral (ODT) Oral Subcutaneous injection Subcutaneous injection Subcutaneous
Indications Acute & preventive Acute Preventive Preventive Preventive
Time to Market 2019 2019 2018 2018 2018
Revenue (2022 est.) $250 million $150 million $2 billion (globally) $2 billion (globally) $1.8 billion
Market Share 20% (estimated) 15% 25% 15% 10%

6. Opportunities & Outlook

  • Expansion into emerging markets: Countries like China, India, and Brazil present high growth potential due to rising migraine prevalence and improving healthcare infrastructure.
  • Development of fixed-dose combinations: Combining rimegepant with NSAIDs or other analgesics could enhance utility.
  • Digital health integration: Telemedicine platforms could facilitate prescriptions, especially in markets with limited specialist access.
  • Biomarker-driven patient stratification: Personalized medicine approaches may optimize treatment efficacy and adoption.

7. Challenges & Mitigation Strategies

Challenge Strategic Response
Market saturation Diversify indications, develop next-generation formulations
Patent expiries File additional patents, focus on formulation/IP extension
Competitive market entry Accelerate approval of pipeline assets, increase marketing investments
Pricing & reimbursement risks Engage payers early, demonstrate value via real-world evidence

8. Conclusions and Actionable Insights

Insight Strategic Implication
Rimegepant’s rapid growth trajectory Favorable investment with monitoring of market share and reimbursement trends
Competition from injectable mAbs Diversify portfolio, invest in formulations, and pipeline expansion
Patent horizon until 2035 Long-term exclusivity potential, warrants sustained R&D funding
Geographic expansion opportunities Focus on emerging economies for growth, requiring tailored strategies
Digital health and personalized medicine Key avenues for enhancing market penetration and patient retention

Key Takeaways

  • Rimegepant sulfate shows promising growth prospects driven by its oral formulation, dual treatment indications, and favorable safety profile.
  • The global migraine market is expanding at a CAGR of 8.6%, with revenues forecasted to exceed $6.8 billion by 2027.
  • Competition remains intense, with injectable CGRP monoclonal antibodies capturing significant market share.
  • Strategic initiatives should focus on advancing pipeline assets, expanding geographies, and engaging payers for favorable reimbursement.
  • Patents extending to 2035 and continued innovation position Rimegepant as a compelling long-term investment candidate.

FAQs

Q1: What is the current patent status of Rimegepant sulfate?

A: Patent protections in the U.S. extend through approximately 2035, covering formulation and method of use, providing a window for market exclusivity.

Q2: How does Rimegepant compare cost-effectively with CGRP monoclonal antibodies?

A: Rimegepant’s oral route and lower per-dose cost (~$30–$40) offer advantages over injectable mAbs, which can cost $600–$700 monthly, potentially impacting payer and patient preferences.

Q3: Are there significant safety concerns associated with Rimegepant?

A: Clinical trials indicate a favorable safety profile, with common adverse events including nausea and dizziness; serious adverse events are rare.

Q4: Which markets represent the highest growth potential?

A: North America remains primary; however, Europe and Asia-Pacific markets are poised for rapid expansion due to increasing migraine prevalence and improving healthcare access.

Q5: What are the key risks to Rimegepant’s market growth?

A: Patent expirations, aggressive competition, pricing pressures, and regulatory hurdles represent primary risks requiring strategic mitigation.


References

  1. MarketWatch, "Global Migraine Market Analysis," 2022.
  2. IQVIA, "Pharmaceutical Sales Data," 2022.
  3. FDA, "Nurtec ODT (Rimegepant) Approval Letter," 2019.
  4. EvaluatePharma, "Top Selling Brands," 2022.
  5. GlobalData, "Migraine Market Forecast," 2022.

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