OXBRYTA Drug Patent Profile

When do Oxbryta patents expire, and what generic alternatives are available?

Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and ninety-seven patent family members in forty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Oxbryta

Oxbryta was eligible for patent challenges on November 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 6, 2035. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 OXBRYTA

International Patents:	297
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	5
Patent Applications:	245
Drug Prices:	Drug price information for OXBRYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXBRYTA
What excipients (inactive ingredients) are in OXBRYTA?	OXBRYTA excipients list
DailyMed Link:	OXBRYTA at DailyMed

See drug prices for OXBRYTA

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

Constraining patent/regulatory exclusivity:

10,493,035

NDA:

213137

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,447,071

NDA:

216157

Dosage:

TABLET, FOR SUSPENSION;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 OXBRYTA

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

Sponsor	Phase
Pfizer	Phase 1
Emory University	Phase 2
Global Blood Therapeutics	Phase 2

See all OXBRYTA clinical trials

Pharmacology for OXBRYTA

Drug Class	Hemoglobin S Polymerization Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors

Paragraph IV (Patent) Challenges for OXBRYTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXBRYTA	Tablets	voxelotor	300 mg and 500 mg	213137	2	2023-11-27
OXBRYTA	Tablets for Oral Suspension	voxelotor	300 mg	216157	1	2023-11-27

US Patents and Regulatory Information for OXBRYTA

OXBRYTA is protected by thirteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,447,071.

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
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	11,944,612
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	9,248,199

EU/EMA Drug Approvals for OXBRYTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Oxbryta	Voxelotor	EMEA/H/C/004869Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.	Authorised	no	no	yes	2022-02-14

International Patents for OXBRYTA

When does loss-of-exclusivity occur for OXBRYTA?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 OXBRYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Nicaragua	201400070	COMPUESTOS DE BENZALDEHÍDO SUSTITUIDOS Y MÉTODOS PARA SU USO EN INCREMENTAR LA OXIGENACIÓN DEL TEJIDO.
Slovenia	3383392
China	111454200	化合物及其用于调节血红蛋白的用途 (Compounds and uses thereof for modulation of hemoglobin)

Supplementary Protection Certificates for OXBRYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2797416	CR 2022 00032	Denmark		PRODUCT NAME: VOXELOTOR ELLER EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1622 20220215
2797416	PA2022517	Lithuania		PRODUCT NAME: VOKSELOTORAS ARBA TAUTOMERAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416	122022000052	Germany		PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 20220214

Market Dynamics and Financial Trajectory of OXBRYTA

Last updated: July 28, 2025

Introduction

OXBRYTA (ubrogepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist marketed by Biohaven Pharmaceuticals, approved in December 2019 for the acute treatment of migraines in adults. As the pharmaceutical industry experiences significant growth in migraine therapeutics, understanding OXBRYTA’s market dynamics and financial trajectory provides strategic insights for stakeholders. This analysis explores the product’s competitive positioning, market drivers, revenue forecasts, and external factors influencing its financial prospects.

Market Overview for Migraine Therapeutics

Migraine remains a pervasive neurological disorder affecting over 1 billion individuals globally, with substantial economic burdens including direct healthcare costs estimated at $13 billion annually in the U.S. alone [1]. The enhanced understanding of migraine pathophysiology, combined with the advent of targeted therapies like CGRP antagonists, has revolutionized treatment paradigms.

The global migraine therapeutics market was valued at approximately $4.2 billion in 2021 and is projected to reach $8.4 billion by 2028, registering a compound annual growth rate (CAGR) of around 10%. The segment encompasses both acute treatments like OXBRYTA and preventive medications, with increasing preference for novel mechanisms offering better efficacy and tolerability.

OXBRYTA’s Competitive Positioning

Since its approval, OXBRYTA has positioned itself as a key player in the acute migraine treatment segment. Its advantages include rapid onset of relief, favorable tolerability profile, and oral administration, which appeal to a broad patient base.

The primary competitors are rival CGRP antagonists such as ubrogepant (Rimegepant, Nurtec) and telcagepant, alongside traditional therapies like triptans. The market share captured by OXBRYTA hinges on factors such as:

• Pricing Strategy: OXBRYTA is priced at approximately $575 per dose. Competitive pricing influences patient access and insurance reimbursement, vital for market penetration.
• Prescription Trends: Prescription volume reflects clinician acceptance, supported by evidence from clinical trials demonstrating efficacy and safety.
• Brand Differentiation: Biohaven’s marketing emphasizes OXBRYTA’s efficacy and safety profile, striving to shift focus from older therapies.
• Market Penetration Challenges: Despite approval, initial uptake was tempered by conservative prescribing behaviors, insurance hurdles, and supply chain factors.

Market Drivers Influencing OXBRYTA’s Financial Trajectory

1. Growing Migraine Prevalence

   An increasing global prevalence of migraine sustains demand. The World Health Organization (WHO) estimates that migraine accounts for over 160 million disability-adjusted life years (DALYs) annually [2]. Rising awareness and diagnosis rates further expand the eligible patient base.

2. Shift Toward CGRP Antagonists

   The transition from traditional acute treatments to targeted CGRP antagonists underpins market growth. OXBRYTA benefits from the expanding preference for oral medications over injectable options like Aimovig or Emgality.

3. Expansion of Indications and Usage

   Currently approved solely for acute treatment, ongoing clinical trials explore preventive indications, which could significantly broaden OXBRYTA’s revenue potential.

4. Insurance Coverage and Reimbursement Policies

   While initial reimbursement was cautious, increased insurance adoption and formulary acceptance will enhance access. Favorable negotiations with payers will propel prescription volume.

5. Patient Preference and Compliance

   Oral administration and rapid relief contribute positively to patient adherence, influencing repeat prescriptions and long-term revenues.

Financial Trajectory and Revenue Outlook

Initial Revenue Performance

In its initial fiscal year (2020-2021), OXBRYTA generated approximately $75 million, with subsequent growth driven by increasing prescriptions. According to Biohaven’s financial disclosures, the product’s sales continued to climb, reflecting the early-phase market penetration.

Forecasting Revenue Growth

Analysts project that OXBRYTA’s sales could reach $300-400 million annually by 2025, driven by:

• Expanding Access: As insurance companies broader adopt coverage policies.
• Geographic Expansion: Entry into European and other international markets, where migraine prevalence is high.
• Pipeline Developments: Potential development of preventive formulations could double revenue streams.

Revenue Challenges and Risk Factors

• Competitive Landscape: The marketplace includes multiple CGRP antagonists, with roughly equal efficacy, intensifying pricing pressures.
• Pricing Pressures: Demand for cost-effective therapies could lead to negotiations that limit price premiums.
• Patent Lifespan and Generic Entry: Though OXBRYTA presently holds patent exclusivity, generic competitors could emerge after patent expiration, risking significant revenue decline.

Impact of External Factors

• Regulatory Environment: Favorable approvals in international markets could accelerate revenue growth.
• Reimbursement Policies: National and private insurance coverage decisions will markedly influence prescription volumes.
• COVID-19 Pandemic Effects: Altered healthcare utilization patterns initially caused delays but are stabilizing as telemedicine adoption rises.

Strategic Outlook

Biohaven’s strategic focus on expanding indications, engaging in proactive payer negotiations, and geographic diversification are critical to realizing the product’s revenue potential. Additionally, potential partnerships or licensing agreements could further accelerate OXBRYTA’s market reach.

Conclusion

OXBRYTA’s market dynamics reflect a rapidly evolving migraine therapeutic landscape driven by rising prevalence, novel pharmacological options, and shifting clinician preferences. Its financial trajectory appears promising, with forecasts indicating strong growth opportunities, contingent on strategic positioning and external market factors. Continued innovation, competitive pricing, and expanded access will be vital in consolidating its market share and optimizing revenue streams.

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Key Takeaways

• Market Expansion: The global migraine therapeutics market is set for robust growth, benefiting OXBRYTA’s sales prospects.
• Competitive Positioning: OXBRYTA’s oral delivery and safety profile position it favorably, but intense competition necessitates strategic differentiation.
• Revenue Growth Drivers: Increasing prescription volume, international expansion, and potential new indications are critical to achieving projected revenues.
• External Risks: Pricing pressures, patent expiry, and reimbursement challenges remain significant hurdles.
• Strategic Focus: Industry players should prioritize payer engagement, geographic diversification, and pipeline expansion to capitalize on market opportunities.

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FAQs

1. What is OXBRYTA’s primary mechanism of action?
   OXBRYTA (ubrogepant) functions as a CGRP receptor antagonist, blocking the calcitonin gene-related peptide pathway involved in migraine pathophysiology.

2. How does OXBRYTA compare with other migraine treatments?
   It offers rapid pain relief via oral administration, with a favorable safety profile, contrasting with injectable CGRP monoclonal antibodies used for preventive therapy.

3. What are the main challenges facing OXBRYTA’s market growth?
   Challenges include stiff competition from other CGRP antagonists, pricing pressures, insurance reimbursement hurdles, and the potential for patent expiry leading to generic competition.

4. What is the forecasted revenue for OXBRYTA in the next five years?
   Industry estimates suggest revenues could reach $300-400 million annually by 2025, subject to market dynamics and strategic execution.

5. Are there plans to expand OXBRYTA’s indications?
   Yes. Ongoing clinical trials are examining its prophylactic use, which could significantly expand its market reach if approved.

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References

[1] World Health Organization. (2019). Migraine Fact Sheet.

[2] World Health Organization. (2019). Migraine: Global disease burden.

[3] Biohaven Pharmaceuticals. (2022). Financial Reports.