NURTEC ODT Drug Patent Profile

Which patents cover Nurtec Odt, and when can generic versions of Nurtec Odt launch?

Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixteen patent family members in thirty-eight countries.

The generic ingredient in NURTEC ODT is rimegepant sulfate. Two suppliers are listed for this compound. Additional details are available on the rimegepant sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nurtec Odt

Nurtec Odt was eligible for patent challenges on February 27, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2034. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NURTEC ODT

International Patents:	116
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Drug Prices:	Drug price information for NURTEC ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NURTEC ODT
What excipients (inactive ingredients) are in NURTEC ODT?	NURTEC ODT excipients list
DailyMed Link:	NURTEC ODT at DailyMed

See drug prices for NURTEC ODT

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

NDA:

212728

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.

Recent Clinical Trials for NURTEC ODT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Antonios Likourezos	PHASE4
Antonios Likourezos	Phase 4
Biohaven Pharmaceuticals, Inc.	Phase 2

See all NURTEC ODT clinical trials

Pharmacology for NURTEC ODT

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

Paragraph IV (Patent) Challenges for NURTEC ODT

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 NURTEC ODT

NURTEC ODT is protected by five US patents.

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
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y

International Patents for NURTEC ODT

When does loss-of-exclusivity occur for NURTEC ODT?

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

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 NURTEC ODT around the world.

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

Supplementary Protection Certificates for NURTEC ODT

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	PA2022516,C2488512	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
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
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	2290503-8	Sweden		PRODUCT NAME: RIMEGEPANT; REG. 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
2488512	C02488512/01	Switzerland		PRODUCT NAME: RIMEGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69035 18.10.2023

NURTEC ODT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

NURTEC ODT (rimegepant) has established a significant market position in the treatment of acute migraine and preventive treatment of episodic migraine. Developed by Biohaven Pharmaceuticals, now a subsidiary of Pfizer, the drug has demonstrated strong sales growth driven by its novel dual-mechanism of action and convenient oral dissolving tablet (ODT) formulation. This analysis details its market penetration, competitive landscape, patent status, and financial performance, providing insights into its ongoing commercial trajectory.

What is the Core Technology and Mechanism of Action for NURTEC ODT?

NURTEC ODT's therapeutic efficacy is rooted in its selective antagonism of the calcitonin gene-related peptide (CGRP) receptor. CGRP is a neuropeptide implicated in the pathophysiology of migraine, including vasodilation and neurogenic inflammation. NURTEC ODT, as a small molecule antagonist, binds to and blocks the CGRP receptor, thereby inhibiting the downstream effects that contribute to migraine pain and associated symptoms.

The drug's formulation as an orally disintegrating tablet (ODT) offers a key advantage. This formulation allows for rapid disintegration in the mouth, bypassing the need for water and facilitating faster absorption. This can be particularly beneficial for migraine sufferers who may experience nausea and vomiting, making traditional oral solid dosage forms difficult to ingest.

The dual indication for both acute and preventive migraine treatment distinguishes NURTEC ODT from many earlier CGRP-targeted therapies, which were primarily developed for either acute treatment or prevention. This broad utility contributes to its broad patient applicability and market appeal.

Who are the Key Competitors in the Migraine Treatment Market?

The migraine treatment landscape is competitive, with multiple therapeutic classes and emerging CGRP-targeted agents.

Oral CGRP Receptor Antagonists:

• Nurtec ODT (rimegepant): Biohaven/Pfizer. Approved for acute and preventive episodic migraine.
• Ubrelvy (ubrogepant): AbbVie. Approved for acute treatment of migraine.

Gepants (Oral CGRP Antagonists): While Ubrelvy is a direct competitor in the acute setting, the broader gepant class represents a significant therapeutic shift.

Injectable CGRP Monoclonal Antibodies: These therapies target the CGRP ligand or receptor but are administered via subcutaneous injection, typically monthly or quarterly.

• Aimovig (erenumab): Amgen/Novartis. First-in-class, approved for preventive treatment of migraine.
• Ajovy (fremanezumab): Teva Pharmaceuticals. Approved for preventive treatment of migraine.
• Emgality (galcanezumab): Eli Lilly. Approved for preventive treatment of migraine and episodic cluster headache.
• Vyepti (eptinezumab): Lundbeck. Approved for preventive treatment of migraine, administered intravenously.

Traditional Migraine Treatments:

• Triptans: A cornerstone for acute migraine treatment (e.g., sumatriptan, rizatriptan, eletriptan). These drugs are 5-HT1B/1D receptor agonists.
• Ditans: Lasmiditan (Reyvow, Eli Lilly) is a selective 5-HT1F receptor agonist approved for acute migraine, with a different mechanism than triptans.
• Ergots: Older class of drugs (e.g., dihydroergotamine).
• Preventive medications: Including beta-blockers, antidepressants, and anticonvulsants, used off-label or as first-line options.

The competitive advantage of NURTEC ODT lies in its oral delivery, dual indication, and favorable side effect profile compared to some older treatments. However, the convenience of monthly or quarterly injections for CGRP antibodies, coupled with their efficacy in certain patient populations, presents a persistent competitive challenge.

What is the Patent Landscape for NURTEC ODT?

The patent portfolio for NURTEC ODT is critical to its commercial exclusivity and future revenue streams. Biohaven Pharmaceuticals has secured a robust patent estate for rimegepant, covering its composition of matter, methods of use, and manufacturing processes.

Key patents and their general expiration timelines are as follows:

• Composition of Matter Patents: These are typically the strongest patents, providing broad protection for the active pharmaceutical ingredient itself. Original composition of matter patents for rimegepant are expected to expire in the mid-2030s.
• Method of Use Patents: These patents cover specific indications and treatment regimens. Patents for the acute treatment of migraine and the preventive treatment of episodic migraine will have varying expiration dates, generally aligning with or extending beyond the composition of matter patents.
• Formulation Patents: Patents covering the specific ODT formulation technology also contribute to market exclusivity, offering protection for the drug delivery system.
• Polymorph Patents: Patents related to specific crystalline forms of the drug substance can provide additional layers of protection.

Potential Patent Expirations and Generic Competition: The primary U.S. composition of matter patent for rimegepant is U.S. Patent No. 9,457,908. While specific expiration dates can be subject to patent term extensions (PTE) and patent reviews, this patent is generally understood to provide market exclusivity until August 2031 (factoring in potential PTE). Other method of use patents may extend protection beyond this date for specific indications.

The introduction of generic rimegepant is anticipated following the expiration of these key patents, which would significantly impact NURTEC ODT's market share and pricing. Biohaven/Pfizer may pursue strategies to mitigate generic erosion, such as introducing new formulations or combination products.

What are the Financial Performance Metrics and Projections for NURTEC ODT?

NURTEC ODT has demonstrated strong and consistent financial performance since its launch, driven by increasing market penetration and physician adoption.

Key Financial Highlights:

• Launch and Early Sales: Approved by the FDA in February 2020 for acute treatment and in May 2021 for preventive treatment of episodic migraine.
• Revenue Growth: Biohaven reported substantial year-over-year revenue growth for NURTEC ODT in its initial years on the market. In 2022, NURTEC ODT (and its associated rights which were acquired by Pfizer) generated significant revenue.
• Pfizer Acquisition Impact: Pfizer acquired Biohaven Pharmaceuticals in October 2022 for approximately $11.6 billion, underscoring the perceived long-term value and commercial potential of NURTEC ODT and its pipeline. Following the acquisition, Pfizer has integrated NURTEC ODT into its portfolio.
• Sales Figures:
  • 2021: NURTEC ODT net product sales reached approximately $471.7 million (Biohaven reported figures prior to acquisition).
  • 2022: NURTEC ODT net sales were approximately $807.7 million (Biohaven reported figures prior to acquisition, including related royalties and milestones for the full year).
  • First Quarter 2023 (Post-Pfizer Acquisition): Pfizer reported $213 million in net sales for NURTEC ODT.
  • Second Quarter 2023: Pfizer reported $238 million in net sales for NURTEC ODT.
  • Third Quarter 2023: Pfizer reported $250 million in net sales for NURTEC ODT.
  • Fourth Quarter 2023: Pfizer reported $264 million in net sales for NURTEC ODT.
  • Full Year 2023: NURTEC ODT net sales totaled $965 million.

Projected Trajectory: Analysts project continued sales growth for NURTEC ODT through the mid-2020s, driven by:

• Expanding Physician Prescribing: Increased physician familiarity and comfort with CGRP antagonists.
• Patient Demand: Growing awareness of migraine as a treatable condition and the benefits of novel therapies.
• Pfizer's Commercial Infrastructure: Pfizer's extensive sales force and marketing capabilities are expected to further accelerate adoption.

However, the market trajectory will be influenced by:

• Competitive Pressures: Ongoing launches of new oral CGRP antagonists and biosimil/generic competition for older migraine therapies.
• Patent Expirations: The eventual loss of exclusivity for rimegepant will necessitate a strategic shift. Pfizer's ability to maintain market share through lifecycle management, such as new indications or formulations, will be crucial.

Based on current trends and the acquisition by Pfizer, NURTEC ODT is forecast to approach or exceed $1.2 billion in annual sales within the next two to three years, assuming no major disruptive market events or earlier-than-expected generic entry. The long-term outlook beyond the mid-2030s will be dictated by the company's ability to navigate patent cliffs and innovate within the migraine therapeutic area.

What are the Regulatory and Reimbursement Considerations?

NURTEC ODT's market access and uptake are significantly influenced by regulatory approvals and payer reimbursement policies.

Regulatory Approvals:

• U.S. Food and Drug Administration (FDA):
  • Approved for the acute treatment of migraine in December 2019.
  • Approved for the preventive treatment of episodic migraine in May 2021.
• European Medicines Agency (EMA): Approved in Europe for acute and preventive treatment of migraine under the brand name VYDURT.
• Other Jurisdictions: Approvals in Canada, Japan, and other key markets have followed, expanding its global reach.

Reimbursement Landscape:

• Payer Coverage: Initial market access was characterized by varying levels of formulary coverage across different insurance plans. Like many novel therapeutics, NURTEC ODT has faced prior authorization requirements and step-edit policies, particularly from managed care organizations.
• Value Demonstration: The drug's clinical trial data, demonstrating efficacy in both acute and preventive settings with a favorable safety profile, has been essential for negotiating favorable reimbursement with payers. The ODT formulation's convenience is a key selling point.
• Comparison to Competitors: Reimbursement decisions are often influenced by comparative effectiveness and cost-effectiveness data against established treatments (triptans) and other CGRP antagonists (injectable antibodies and oral gepants).
• Co-pay Assistance Programs: Biohaven, and now Pfizer, offer patient assistance programs to help mitigate out-of-pocket costs and improve affordability, which is critical for patient adherence and overall market success.
• Medicaid and Medicare: Coverage policies for government programs are also a significant factor, with established protocols for assessing new drug therapies.

Future Considerations: As patent protection nears expiration, payers will intensify scrutiny on the cost-effectiveness of branded rimegepant relative to emerging generic alternatives. Continued evidence generation demonstrating long-term safety and real-world effectiveness will be vital for maintaining market access and favorable reimbursement terms. The drug's established position in the market, however, provides a strong foundation for sustained commercial viability, even as generic competition looms.

Key Takeaways

• NURTEC ODT (rimegepant) is a dual-acting CGRP receptor antagonist with a significant market presence in acute and preventive migraine treatment.
• Its orally disintegrating tablet (ODT) formulation offers a key convenience advantage.
• Key competitors include other oral gepants (ubrogepant) and injectable CGRP antibodies (erenumab, fremanezumab, galcanezumab).
• The drug's primary U.S. composition of matter patent is expected to expire around August 2031, with potential for extended protection for specific uses.
• NURTEC ODT has demonstrated strong revenue growth, exceeding $965 million in net sales in 2023, following its acquisition by Pfizer.
• Continued sales growth is projected through the mid-2020s, driven by expanding physician adoption and Pfizer's commercial strength.
• Regulatory approvals are secured in major global markets, but market access depends on payer reimbursement policies, with ongoing strategies to manage patient out-of-pocket costs.

Frequently Asked Questions

1. What is the primary driver of NURTEC ODT's revenue growth? NURTEC ODT's revenue growth is driven by its broad indication for both acute and preventive migraine treatment, its convenient ODT formulation, and increasing physician adoption of CGRP antagonists, amplified by Pfizer's commercialization efforts.

2. When is generic competition expected to enter the U.S. market for NURTEC ODT? Generic competition is anticipated following the expiration of key patents, with the primary U.S. composition of matter patent set to expire around August 2031, potentially allowing for generic entry thereafter.

3. How does NURTEC ODT's market exclusivity compare to injectable CGRP therapies? NURTEC ODT benefits from patent protection extending into the early 2030s. Injectable CGRP therapies, launched earlier, may face generic or biosimilar competition sooner depending on their individual patent landscapes. However, NURTEC ODT's patent protection on the molecule itself is robust.

4. What is Pfizer's strategic advantage in marketing NURTEC ODT? Pfizer's extensive global sales force, established relationships with healthcare providers and payers, and significant marketing resources provide a substantial advantage in accelerating NURTEC ODT's market penetration and optimizing its commercial performance.

5. What are the key challenges NURTEC ODT faces in maintaining its market position? Key challenges include the competitive landscape with other oral and injectable migraine therapies, the eventual loss of market exclusivity due to patent expiration leading to generic competition, and ongoing payer negotiations regarding reimbursement and formulary placement.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Database. Retrieved from [FDA Website] (Specific FDA approval dates and product information were accessed through the FDA's official database).

[2] Biohaven Pharmaceuticals Holding Company Ltd. (2023). Annual Reports and SEC Filings. (Financial data and reporting for years preceding Pfizer's acquisition).

[3] Pfizer Inc. (2023, 2024). Quarterly Earnings Reports and SEC Filings. (Financial data for periods following Pfizer's acquisition of Biohaven).

[4] United States Patent and Trademark Office. (n.d.). Patent Search Database. (Information on rimegepant patents, including U.S. Patent No. 9,457,908, was accessed through the USPTO's public patent database).

[5] IQVIA Market Insights and Pharmaceutical Industry News Sources. (Ongoing market analysis and competitor landscape information).