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NURTEC ODT Drug Patent Profile

Which patents cover Nurtec Odt, and what generic alternatives are available?

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 six patent family members in thirty-six countries.

The generic ingredient in NURTEC ODT is rimegepant sulfate. One supplier is 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 25, 2033. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for NURTEC ODT

International Patents:	106
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Drug Prices:	Drug price information 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	Phase 4
Weill Medical College of Cornell University	Phase 2
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 and two FDA Regulatory Exclusivities.

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
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
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:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

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
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

Supplementary Protection Certificates for NURTEC ODT

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

NURTEC ODT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NURTEC ODT

Introduction

NURTEC ODT, developed by Biohaven Pharmaceuticals, has been a significant player in the migraine treatment market since its approval by the FDA in 2020. This article delves into the market dynamics and financial trajectory of NURTEC ODT, highlighting its performance, competitive landscape, and future prospects.

Approval and Indications

NURTEC ODT, also known as rimegepant, received FDA approval for the acute treatment of migraine in February 2020. Later, in May 2021, it was approved for the preventive treatment of episodic migraines, making it the first oral medication to receive dual approvals for both treatment and prevention of migraines[4].

Market Performance

Prescription Volume and Revenue

By the end of June 2022, NURTEC ODT had achieved over 2.2 million prescriptions and was prescribed by over 79,000 unique prescribers, marking a significant increase of 11,500 prescribers from the first quarter of 2022. This growth reflects strong product demand and continued traction in the prescribing community[1].

In the second quarter of 2022, net product revenue from NURTEC ODT sales totaled $194 million, a 57% sequential increase from the first quarter of 2022 and a 109% increase from the second quarter of 2021. This revenue growth was driven by increased prescription sales volume and a favorable pack mix per prescription[1].

Quarterly Financial Highlights

• Q1 2022: Net product revenue was $123.6 million, with a significant increase in sales volume and improvements in net price realization due to decreases in sales allowances[2].
• Q2 2022: Net product revenue was $194 million, up sequentially by 57% and by 109% compared to the same period in 2021[1].
• Q4 2020: Net product revenues were $35.1 million, representing a 98% increase from the third quarter of 2020[5].

Competitive Landscape

Market Share and Competitors

NURTEC ODT has maintained a strong market position, capturing 56% of new-to-brand prescriptions in the migraine treatment market, outperforming competitors like Ubrelvy from AbbVie, which held 44.1% of the market share[3].

The migraine prevention market is crowded with injectable CGRP drugs such as Amgen’s Aimovig, Eli Lilly’s Emgality, and Teva’s Ajovy. However, NURTEC ODT’s oral formulation provides a convenience edge, making it a preferred option for many patients[4].

Recent Developments

AbbVie’s Qulipta, an oral migraine preventative, has been seen as a potential competitor, but analysts suggest it may erode share from injectable CGRPs rather than directly impacting NURTEC ODT’s market share[4].

Financial Projections and Milestones

Revenue Projections

Consensus estimates predict NURTEC ODT sales to reach $1.28 billion in 2023 and $1.78 billion in 2024. Piper Sandler analysts expect the drug to achieve $845 million in full-year 2022 revenue, slightly above the consensus forecast[4].

Funding and Partnerships

Biohaven has secured significant funding, including $425 million in committed capital from Sixth Street and Royalty Pharma agreements as of March 2021. Additional funding of $100 million is anticipated from the Royalty Pharma agreement upon the start of the oral zavegepant Phase 3 trial[5].

Merger and Acquisition

The acquisition of Biohaven by Pfizer, which includes antitrust approvals from the FTC, is expected to enhance the global reach and commercialization of NURTEC ODT. This deal is valued up to $1.24 billion[1].

Patient Affordability and Support Programs

Copay Programs and Rebates

Biohaven has invested in copay programs and patient affordability support, which have driven volume and net revenue growth. These programs have helped improve patient affordability, especially as patients satisfy their annual deductible obligations[1].

Future Prospects and Pipeline

Clinical and Preclinical Programs

Biohaven is continuing to support the commercialization of NURTEC ODT while developing its product candidates through clinical and preclinical programs in various common and rare disorders. The company expects to reach significant pipeline milestones in the coming quarters[1].

Market Expansion

The dual approvals for NURTEC ODT have positioned it for continued growth in both the acute and preventive migraine treatment markets. The convenience of an oral formulation and the drug’s efficacy are expected to maintain its market dominance[4].

"Nurtec Juggernaut Continues Unabated," Piper Sandler analyst Christopher Raymond wrote in a note to clients, highlighting the significant growing trajectory for Nurtec in both treatment and prevention[4].

Key Takeaways

• Strong Revenue Growth: NURTEC ODT has shown significant revenue growth, with a 57% sequential increase in Q2 2022 and a 109% increase from the same period in 2021.
• Market Dominance: The drug has maintained a strong market position, capturing a majority of new-to-brand prescriptions in the migraine treatment market.
• Competitive Edge: The oral formulation of NURTEC ODT provides a convenience edge over injectable competitors.
• Financial Projections: Consensus estimates predict substantial revenue growth for NURTEC ODT in the coming years.
• Patient Support: Biohaven’s investments in copay programs and patient affordability support have been crucial in driving revenue growth.

FAQs

1. What are the dual approvals for NURTEC ODT? NURTEC ODT is approved for both the acute treatment and preventive treatment of episodic migraines.

2. How has NURTEC ODT performed in terms of prescriptions and revenue? By June 2022, NURTEC ODT had achieved over 2.2 million prescriptions and generated $194 million in net product revenue for Q2 2022, a 57% increase from Q1 2022.

3. Who are the main competitors of NURTEC ODT in the migraine market? The main competitors include injectable CGRP drugs like Amgen’s Aimovig, Eli Lilly’s Emgality, and Teva’s Ajovy, as well as oral competitors like AbbVie’s Qulipta.

4. What is the significance of the Pfizer acquisition of Biohaven? The acquisition, valued up to $1.24 billion, is expected to enhance the global reach and commercialization of NURTEC ODT.

5. What are the financial projections for NURTEC ODT in the coming years? Consensus estimates predict NURTEC ODT sales to reach $1.28 billion in 2023 and $1.78 billion in 2024.

Sources

1. Biohaven Reports Second Quarter 2022 Financial Results and Reports Recent Business Developments. PR Newswire.
2. Biohaven Reports First Quarter 2022 Financial Results and Reports Recent Business Developments. BioSpace.
3. No Small Feat: Nurtec ODT. Pharmaceutical Executive.
4. Biohaven's migraine blockbuster-in-waiting snags nearly $500M for year after nabbing lucrative dual approvals. FiercePharma.
5. Biohaven Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Developments. PR Newswire.