ubrelvy Drug Patent Profile

Which patents cover Ubrelvy, and what generic alternatives are available?

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

The generic ingredient in UBRELVY is ubrogepant. There is one drug master file entry for this compound. Two suppliers are 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 fourteen 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.

There are three tentative approvals for the generic drug (ubrogepant), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ubrelvy

US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for ubrelvy
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ubrelvy
What excipients (inactive ingredients) are in ubrelvy?	ubrelvy excipients list
DailyMed Link:	ubrelvy at DailyMed

See drug prices for ubrelvy

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

NDA:

211765

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

Sponsor	Phase
AbbVie	Phase 1
Chicago Headache Center & Research Institute	Phase 4
AbbVie	Phase 4

See all ubrelvy clinical trials

Pharmacology for ubrelvy

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

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

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

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

Saudi Arabia

South Korea

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	2015214502
Australia	2019226239
Australia	2021245229
Australia	2021409718
Australia	2023258317
Australia	2025220825
Brazil	112016017999

Supplementary Protection Certificates for ubrelvy

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	PA2023532	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814

Ubrelvy (ubrogepant) Market Dynamics and Financial Trajectory: Competitive Landscape, Pricing/Access, Revenue Drivers, and Patent/Generic Risk

Last updated: July 23, 2026

Ubrelvy (ubrogepant) generated meaningful migraine-acute-care revenue traction in the US after launch, with growth tied to expansion of treated patients, formulary inclusion, and branded-only dynamics in CGRP receptor antagonist acute migraine. Financial trajectory is shaped by (1) class competition from Nurtec ODT (rimegepant), (2) payer movement toward lower-cost mix, rebates, and step edits for acute CGRP products, (3) dosing and use-pattern shifts driven by 2021-2024 clinical adoption, and (4) loss-of-exclusivity risk timing for additional ubrogepant SKUs and follow-on exclusivities.

What market dynamics drive Ubrelvy (ubrogepant) revenue in acute migraine?

Ubrelvy is an oral small-molecule CGRP receptor antagonist indicated for acute treatment of migraine with or without aura in adults. Revenue dynamics are driven by: patient adoption, payer coverage (formularies and prior authorization), competitive positioning versus CGRP alternatives, and share of total migraine acute therapy spend.

How does payer coverage affect Ubrelvy demand?

Payer management has typically targeted high-cost branded acute migraine therapies through a mix of:

• formulary tier placement (preferred vs non-preferred),
• prior authorization and step therapy,
• quantity limits aligned with monthly dosing,
• network contracting rebates that change net pricing.

For Ubrelvy, payer coverage strategy tends to track migraine prevalence and the size of the acute-therapy patient pool, not just specialty segmentation. The key commercial issue is whether payers treat ubrogepant as “incremental” versus “substitutable” within the CGRP acute class.

What competitive forces matter most: Nurtec ODT, triptans, and other migraine options?

Ubrelvy’s competitive set in acute migraine includes:

• CGRP antagonists: rimegepant (Nurtec ODT) as the closest branded alternative.
• Triptans: a legacy cheaper class with entrenched prescriber familiarity and broad formularies.
• NSAIDs/other acute agents: clinically used in milder or earlier-step settings.
• Newer pipeline and combination strategies: typically influence long-term uptake even when not immediately replacing current standard-of-care.

Revenue pressure comes from payer and PBM incentives that favor the lowest net-cost CGRP option while maintaining class access.

How does Ubrelvy financial trajectory compare with rimegepant (Nurtec ODT) and other migraine brands?

Ubrelvy and rimegepant are “same-class” acute CGRP products that compete for the same formulary slots and prescriber mindshare. The financial comparison is largely a function of:

• initial share of new-to-class initiations,
• persistency and repeat use patterns,
• payer contracting outcomes and patient mix,
• label expansions that broaden addressable use.

What role does Qulipta (atogepant) play in the acute market mix?

Qulipta (atogepant) is a preventive CGRP pathway product. Its growth can indirectly affect acute spend by reducing attack frequency for some patients, thereby shifting utilization from acute rescue to preventive management. The magnitude depends on patient segmentation: high-frequency episodic and chronic migraine patients will allocate more budget to prevention as access expands.

When did Ubrelvy reach key commercial milestones, and what does that imply for financial growth?

For a drug like Ubrelvy, milestones usually cluster around:

• US launch and early uptake,
• formulary expansion waves and payer coverage normalization,
• label expansion milestones that increase eligible populations,
• competition dynamics that compress or reallocate share within the CGRP acute segment.

A financial trajectory reading depends on when net-to-gross stabilizes and when payer breadth broadens from initial restricted access to broader commercial coverage.

How do label changes influence addressed patient populations?

Each incremental label expansion expands the “addressable” migraine population for prescribers and payers. In migraine acute therapy, label breadth tends to drive:

• earlier treatment selection (vs resorting after triptan failure),
• broader eligibility for patients with contraindications to triptans,
• more consistent monthly utilization, improving revenue durability.

What is the pricing and reimbursement profile for Ubrelvy?

Ubrelvy is a branded product with net pricing meaningfully influenced by:

• PBM rebate structures,
• Medicare Part D formularies and plan designs,
• commercial plan-specific contracting,
• specialty pharmacy and distribution channel management.

How does the acute CGRP class affect net pricing stability?

Within the CGRP acute class, PBMs typically use tier placement and contract terms to drive cost minimization. This means net price can fluctuate even when list price is stable. For Ubrelvy, the key financial question is how often payers switch preference between ubrogepant and rimegepant based on rebate dynamics, patient copay thresholds, and prior authorization criteria.

What does the financial trajectory depend on in channel and volume?

Ubrelvy’s revenue path depends on:

• number of treated patients,
• average prescriptions per treated patient (scripts and refills),
• percent uptake among eligible migraine patients,
• persistence after switching patterns.

Because CGRP acute therapies are high-frequency rescue options for many patients, modest changes in persistence or repeat dosing can move revenue meaningfully.

How many patents protect Ubrelvy (ubrogepant), and when do exclusivities end?

Ubrelvy’s competitive future is shaped by its patent estate, plus any regulatory exclusivities for specific forms, uses, and manufacturing processes. The practical revenue risk is not only “first generic entry,” but also “carve-out” entry via authorized generics, at-risk launches, or challengers targeting narrower claims.

What are the typical patent estate components for small-molecule branded migraine drugs?

For ubrogepant, the relevant protection buckets generally include:

• composition of matter claims covering the active ingredient or key chemical entities,
• formulation claims covering specific solid state or dosage form characteristics,
• method-of-use claims tied to acute migraine treatment regimens,
• manufacturing/process claims covering synthetic routes or intermediates,
• regulatory exclusivities tied to new chemical entity status and labeling.

The market implication is that even when one layer expires, other layers can extend “practical exclusivity,” delaying full generic penetration.

What generic entry risks exist for Ubrelvy?

Generic entry risk typically follows two pathways:

1. Paragraph IV ANDA challenges that force litigation and settlement-based “at-risk” timing.
2. Non-challenged ANDAs that wait for expiration of listed Orange Book patents and/or end of exclusivity.

How does litigation and settlement affect launch timing?

If ANDA challenges settle, the generic launch can be deferred until agreed design-around or “entry carve-out” dates. Alternatively, if litigation results in invalidation or non-infringement findings, entry can occur earlier than statutory expiration.

For investors and commercial planners, the critical question is whether any settlement creates a defined “switch-over date” that payers can plan around for contracting.

What is the Orange Book status of Ubrelvy, and which patents are most relevant to generic competition?

Orange Book listings determine which patents can be challenged and which control ANDA approval timing. The practical impact for Ubrelvy is:

• patents with the highest likelihood of being “but-for” barriers to approval (core composition/use claims),
• patents with narrower claims that may not block approval if found not infringed or invalid.

Which patents typically drive the biggest commercial risk?

For branded migraine products, the strongest revenue protection usually comes from:

• active ingredient composition claims,
• key method-of-use claims,
• critical formulation/manufacturing claims.

In contrast, weaker or easily designed-around patents may reduce generic protection even if they remain listed.

What patent litigation affects Ubrelvy, and how does it map to commercialization risk?

Patent litigation impacts:

• whether generics can launch at-risk,
• whether settlements establish entry dates,
• whether carve-outs preserve branded-only periods for specific dosage forms or indications.

What is the typical settlement structure in acute CGRP challenges?

Common outcomes include:

• delayed entry until a defined date,
• “carve-out” settlements where entry is permitted for certain strengths, packs, or formulations while other claims remain in force,
• royalty structures if generics enter earlier under specific constraints.

The commercialization impact is direct: payer switches to lower-cost alternatives only when supply certainty and claim clearance are established.

How does Ubrelvy compare with competitor CGRP options on access and formulary positioning?

Competitor dynamics in acute CGRP therapy are shaped by:

• formulary breadth across commercial payers,
• Medicare Part D uptake,
• manufacturer contracting strategies,
• patient affordability programs and copay assistance impacts.

What does “preferred” status mean for branded revenue?

Preferred positioning usually increases:

• persistence,
• lower rejection rates at the pharmacy,
• higher prescribing volume from PCPs and specialists.

In migraine, this can reduce underuse due to prior authorization delays.

What manufacturing and IP barriers affect generic switching for Ubrelvy?

Even when patents expire or are cleared, market entry can be slowed by:

• validated manufacturing capabilities at scale,
• stability and bioequivalence requirements for any formulation variants,
• supply chain readiness and specialty distribution contracts.

For oral small molecules, these hurdles are typically manageable, but the timing still influences how quickly payer formularies can implement switching.

What revenue exposure does Ubrelvy face from competition and loss of exclusivity?

Revenue exposure comes from two fronts:

• competitive substitution within the acute CGRP class (uborogepant vs rimegepant),
• broader generic/at-risk penetration when key Orange Book barriers fall.

How do competition and exclusivity changes interact?

If rimegepant holds preferred status during the approach to ubrogepant exclusivity expiry, Ubrelvy can see:

• share dilution earlier than expected,
• net pricing compression before generic entry.

If generic threats are credible, payers may also tighten utilization controls in anticipation of switching.

Key Takeaways

• Ubrelvy’s market dynamics are dominated by payer coverage management, within-class substitution against Nurtec ODT, and CGRP acute usage patterns that drive repeat dosing and persistence.
• Financial trajectory depends on treated patient growth and net pricing stability under PBM rebate contracting, not list price.
• Generic and exclusivity risk is determined by Orange Book patents and litigation/settlement timing, which can delay or enable launch even after one exclusivity layer ends.
• Competitive substitution in the CGRP acute class can compress Ubrelvy share before loss of exclusivity, changing both volume and net price.

FAQs

How does Ubrelvy use pattern (dose frequency and persistence) influence revenue?

Revenue is highly sensitive to repeat prescriptions per treated patient because acute CGRP use is recurrent for a subset of migraine patients and drives monthly script volume.

What payer mechanisms most often limit Ubrelvy uptake?

Prior authorization, step edits, formulary tier placement, and quantity limits commonly shape initial and ongoing demand.

What is the main revenue threat to Ubrelvy: rimegepant competition or generic entry?

For many periods, class competition and payer preference shifts drive faster share changes than generic entry, with generic risk becoming the dominant factor when Orange Book barriers and litigation timelines converge.

How do label expansions alter Ubrelvy’s addressable market?

Each label expansion broadens the eligible migraine population, which typically increases prescribing eligibility and can improve average persistence by allowing broader patient segments to remain on the therapy.

What commercial strategy tends to matter most near exclusivity loss?

Contracting readiness, payer switching plans, and supply and distribution certainty are the key drivers of how quickly branded revenue declines once barriers loosen.

References

1. FDA. Drugs@FDA: Product Information for Ubrelvy (ubrogepant). US Food and Drug Administration.
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. FDA. Labeling for Ubrelvy (ubrogepant). US Food and Drug Administration.
4. SEC. Quarterly and annual reports of AbbVie Inc. and Allergan (if applicable) discussing Ubrelvy performance and pipeline/competitive updates.
5. SEC. Quarterly and annual reports of Biohaven Pharmaceutical Holding Co. discussing Nurtec ODT and CGRP competitive context.

DrugChatter Q&A for UBRELVY

Cost of ubrelvy in canada?
Ubrelvy out of pocket cost?
How much does ubrelvy cost in canada?
Ubrelvy price canada?
Ubrelvy generic availability 2026?