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Last Updated: December 23, 2024

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UBRELVY Drug Patent Profile


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

Ubrelvy is a drug marketed by Abbvie and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and three patent family members in forty-five countries.

The generic ingredient in UBRELVY is ubrogepant. One supplier is listed for this compound. Additional details are available on the ubrogepant profile page.

DrugPatentWatch® Generic Entry Outlook for Ubrelvy

Ubrelvy was eligible for patent challenges on December 23, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2035. This may change due to patent challenges or generic licensing.

There have been two 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

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Drug patent expirations by year for UBRELVY
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for UBRELVY
Generic Entry Date for UBRELVY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 UBRELVY

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

SponsorPhase
AbbViePhase 1
Chicago Headache Center & Research InstitutePhase 4
AbbViePhase 4

See all UBRELVY clinical trials

Paragraph IV (Patent) Challenges for UBRELVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UBRELVY Tablets ubrogepant 50 mg and 100 mg 211765 4 2023-12-26

US Patents and Regulatory Information for UBRELVY

UBRELVY is protected by nine US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UBRELVY is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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
Abbvie UBRELVY ubrogepant TABLET;ORAL 211765-001 Dec 23, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Abbvie UBRELVY ubrogepant TABLET;ORAL 211765-001 Dec 23, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Abbvie UBRELVY ubrogepant TABLET;ORAL 211765-001 Dec 23, 2019 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie UBRELVY ubrogepant TABLET;ORAL 211765-002 Dec 23, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>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 UBRELVY

When does loss-of-exclusivity occur for UBRELVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15214502
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷  Subscribe

Patent: 19226239
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷  Subscribe

Patent: 21245229
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷  Subscribe

Patent: 21409718
Patent: TREATMENT OF MIGRAINE
Estimated Expiration: ⤷  Subscribe

Patent: 23258317
Patent: Tablet formulation for CGRP-active compounds
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2016017999
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 37315
Patent: FORMULATION DE COMPRIME POUR COMPOSES ACTIFS VIS-A-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 37942
Patent: COMBINAISONS A DOSE FIXE DE COMPOSES ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 06184
Patent: TRAITEMENT DE LA MIGRAINE (TREATMENT OF MIGRAINE)
Estimated Expiration: ⤷  Subscribe

China

Patent: 5939715
Patent: 抗病毒化合物的固定剂量组合 (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 5960397
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷  Subscribe

Patent: 2022818
Patent: CGRP-活性化合物的片剂制剂 (Tablet formulation for CGRP-active compounds)
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 02188
Patent: NOUVEAUX SYSTÈMES DE DÉSINTÉGRATION DE FORMES DOSIFIÉES PHARMACEUTIQUES (NOVEL DISINTEGRATION SYSTEMS FOR PHARMACEUTICAL DOSAGE FORMS)
Estimated Expiration: ⤷  Subscribe

Patent: 02210
Patent: COMPOSITION PHARMACEUTIQUE D'INHIBITEURS SÉLECTIFS DE LA NS3/4A DU HCV (PHARMACEUTICAL COMPOSITION OF SELECTIVE HCV NS3/4A INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 02211
Patent: COMBINAISONS À DOSE FIXE DE COMPOSÉS ANTIVIRAUX (FIXED-DOSE COMBINATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 02564
Patent: FORMULATION DE COMPRIMÉ POUR COMPOSÉS ACTIFS VIS-À-VIS DU CGRP (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 37412
Patent: FORMULATIONS À DISPERSION SOLIDE DE COMPOSÉS ANTIVIRAUX (SOLID DISPERSION FORMULATIONS OF ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 32218
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6828
Patent: פורמולציית טבליה לחומרים הפועלים על cgrp (Tablet formulation for cgrp-active compounds)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 91669
Estimated Expiration: ⤷  Subscribe

Patent: 66490
Estimated Expiration: ⤷  Subscribe

Patent: 17505306
Patent: CGRP活性化合物の錠剤製剤
Estimated Expiration: ⤷  Subscribe

Patent: 19108366
Patent: CGRP活性化合物の錠剤製剤 (TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 16010169
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷  Subscribe

Patent: 21006790
Patent: FORMULACION DE TABLETA PARA COMPUESTOS ACTIVOS DE PEPTIDO RELACIONADO CON EL GEN DE CALCITONINA. (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS.)
Estimated Expiration: ⤷  Subscribe

Patent: 23007575
Patent: TRATAMIENTO DE LA MIGRAÑA. (TREATMENT OF MIGRAINE.)
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 96578
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ (TABLETS PREPARATION TECHNOLOGY FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 19123406
Patent: ТЕХНОЛОГИЯ ПРИГОТОВЛЕНИЯ ТАБЛЕТОК ДЛЯ CGRP-АКТИВНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 6371613
Patent: CGRP صيغة قرص لمركبات نشطة تجاه (Tablet Formulation for CGRP-Active Compounds)
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2448369
Estimated Expiration: ⤷  Subscribe

Patent: 160113296
Patent: CGRP-활성 화합물에 대한 정제 제제 (TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 220136460
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 230107902
Patent: CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

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 UBRELVY around the world.

Country Patent Number Title Estimated Expiration
Australia 2021409718 ⤷  Subscribe
Taiwan I487706 ⤷  Subscribe
Croatia P20161641 ⤷  Subscribe
Australia 2011326454 Piperidinone carboxamide azaindane CGRP receptor antagonists ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UBRELVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2638042 122023000058 Germany ⤷  Subscribe PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042 PA2023532 Lithuania ⤷  Subscribe PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042 CR 2023 00033 Denmark ⤷  Subscribe PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042 301248 Netherlands ⤷  Subscribe PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

UBRELVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ubrelvy

Introduction to Ubrelvy

Ubrelvy, developed by AbbVie, is a significant player in the calcitonin gene-related peptide (CGRP) class of migraine treatments. It is specifically designed for the acute relief of migraine attacks and has been gaining traction in the market since its approval.

Market Growth and Projections

The migraine market is poised for substantial growth, driven largely by the increased prescription of CGRP antagonists. According to GlobalData, the migraine market across seven major markets (7MM) is expected to grow from $9.2 billion in 2023 to $16.4 billion by 2033, with a compound annual growth rate (CAGR) of 6.0%[4].

Competitive Landscape

Ubrelvy operates in a competitive landscape dominated by other CGRP antagonists. Biohaven’s Nurtec ODT, for instance, is a formidable competitor, approved for both acute and preventive therapy. Despite this, analysts from Evercore ISI suggest that Ubrelvy’s market share, although expected to decrease slightly due to Nurtec’s gains, will still remain significant. Evercore projects that Ubrelvy’s share of the CGRP acute market will fall from 38% to 31%, but the overall growth of the CGRP class will benefit both Ubrelvy and Nurtec[1].

Financial Performance

Recent Financial Results

In the third quarter of 2024, Ubrelvy reported net revenues of $269 million, representing a 15.3% increase from the previous year. This growth is part of a broader trend where AbbVie’s neuroscience portfolio, which includes Ubrelvy, saw a 15.6% increase in net revenues on a reported basis[2].

For the full year 2023, Ubrelvy’s net revenues were $234 million, an increase of 18.9% from the previous year. This indicates a consistent upward trajectory for the drug[5].

Peak Sales Projections

Analysts are optimistic about Ubrelvy’s long-term potential. Evercore ISI suggests that Ubrelvy could achieve peak sales of over $2 billion, surpassing AbbVie’s initial estimates of $1 billion. This optimism is fueled by the robust growth outlook for the CGRP class, with projected growth of 200% in the acute setting and 150% in the preventive setting over the next five years[1].

Market Drivers

Increasing Adoption of CGRP Antagonists

The CGRP class is gaining traction due to its efficacy and the growing awareness among healthcare providers. The survey of 25 neurologists by Evercore ISI indicates a strong preference for CGRP antagonists, which is expected to drive the market forward[1].

Comparative Advantage

Ubrelvy, as an oral gepant, offers a more convenient and potentially more effective treatment option compared to injectable CGRP treatments. This convenience factor is likely to contribute to its market share and growth[1].

Challenges and Limitations

Reimbursement Restrictions

One of the significant challenges facing CGRP antagonists, including Ubrelvy, is reimbursement restrictions. These drugs have higher annual costs compared to traditional treatments, which can limit their adoption due to reimbursement constraints[4].

Patent Expiries

The patent expiry dates for these drugs are a critical factor in their long-term financial trajectory. Ubrelvy, with one of the later patent expiry dates, is expected to remain a top-selling drug in the migraine market in 2033, with projected sales of $1.07 billion[4].

Impact of the Pandemic

The COVID-19 pandemic has had a mixed impact on pharmaceutical launches, including those in the migraine market. While some launches, like Wegovy and Nurtec, have performed exceptionally well, others have underperformed. However, Ubrelvy has been one of the exceptions, showing significant growth despite the pandemic challenges[3].

Expert Insights and Market Analysis

Analysts from Piper Sandler and Evercore ISI have been bullish on Ubrelvy’s prospects. Evercore’s Josh Schimmer noted that the peak sales potential for Ubrelvy could be closer to $2 billion-plus, indicating strong market confidence in the drug[1].

Key Takeaways

  • Market Growth: The migraine market is expected to grow significantly, driven by CGRP antagonists.
  • Financial Performance: Ubrelvy has shown consistent revenue growth, with a 15.3% increase in the third quarter of 2024.
  • Peak Sales Projections: Analysts estimate peak sales of over $2 billion for Ubrelvy.
  • Market Drivers: Increasing adoption of CGRP antagonists and the comparative advantage of oral gepants.
  • Challenges: Reimbursement restrictions and patent expiries.

FAQs

Q: What is Ubrelvy used for? A: Ubrelvy is used for the acute relief of migraine attacks.

Q: How is the market for CGRP antagonists expected to grow? A: The market is expected to grow at a CAGR of 6.0% from $9.2 billion in 2023 to $16.4 billion by 2033.

Q: What are the peak sales projections for Ubrelvy? A: Analysts estimate peak sales of over $2 billion for Ubrelvy.

Q: What are the main challenges facing Ubrelvy in the market? A: Reimbursement restrictions and patent expiries are significant challenges.

Q: How has the COVID-19 pandemic affected the launch of Ubrelvy? A: Despite pandemic challenges, Ubrelvy has shown significant growth, unlike many other pharmaceutical launches.

Sources

  1. FiercePharma: AbbVie's new migraine meds could each pull in $2B at peak thanks to growth in CGRP class, analysts say[1].
  2. PR Newswire: AbbVie Reports Third-Quarter 2024 Financial Results[2].
  3. IQVIA: Overcoming Pharma's Launch Performance Problem[3].
  4. Clinical Trials Arena: Migraine market expected to reach $16.4bn across 7MM by 2033[4].
  5. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[5].

More… ↓

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.