UBROGEPANT - Generic Drug Details

What are the generic drug sources for ubrogepant and what is the scope of freedom to operate?

Ubrogepant is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ubrogepant has one hundred and ten patent family members in forty-seven countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for UBROGEPANT

International Patents:	110
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	15
Patent Applications:	374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UBROGEPANT
What excipients (inactive ingredients) are in UBROGEPANT?	UBROGEPANT excipients list
DailyMed Link:	UBROGEPANT at DailyMed

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

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 UBROGEPANT

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

Sponsor	Phase
H. Lundbeck A/S	PHASE1
AbbVie	PHASE3
AbbVie	Phase 1

See all UBROGEPANT clinical trials

Generic filers with tentative approvals for UBROGEPANT

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET
		100MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for UBROGEPANT

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

Anatomical Therapeutic Chemical (ATC) Classes for UBROGEPANT

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for UBROGEPANT

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 UBROGEPANT

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

International Patents for UBROGEPANT

Country	Patent Number	Title	Estimated Expiration
Japan	2013542260
South Korea	20230107902	CGRP-활성 화합물에 대한 정제 제제 (CGRP- TABLET FORMULATION FOR CGRP-ACTIVE COMPOUNDS)
Australia	2025220825
Australia	2021245229
European Patent Office	3102564
European Patent Office	3237412
Serbia	55416	ANTAGONISTI PIPERIDINON KARBOKSAMID AZAINDAN CGRP RECEPTORA (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS)

Supplementary Protection Certificates for UBROGEPANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	C202330039	Spain		PRODUCT NAME: ATOGEPANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1750; DATE OF AUTHORISATION: 20230811; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1750; DATE OF FIRST AUTHORISATION IN EEA: 20230811
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	C20230034	Finland
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	PA2023532,C2638042	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811

Ubrogepant: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

Ubrogepant (Ubrelvy) has moved from early migraine-acute launch demand toward a broader managed-care and competitor-defined market, where realized revenue is driven by (1) oral CGRP competition, (2) payer adoption and step-edit behavior, (3) channel mix of neurology vs primary care prescribing, and (4) persistence and switching within the class. Financial trajectory has followed the standard acute- migraine pattern: initial growth through coverage gains, then pressure as rival oral CGRP agents expanded their formulary positions and as manufacturers targeted dose convenience and patient support programs.

What has driven ubrogepant’s market adoption since launch?

Core demand drivers

• Oral route for acute migraine: Ubrogepant is an oral CGRP receptor antagonist used for acute treatment of migraine. Its convenience supports adoption beyond settings where injectable therapies dominate.
• Payer coverage and formulary positioning: Ubrogepant’s market access hinges on managed-care decisions, including formulary tier placement and prior authorization requirements. Product growth is typically strongest when coverage broadens from initial specialty pharmacy handling toward broader retail and mail use.
• Switching dynamics inside the CGRP class: Ubrogepant’s share depends on switching between oral CGRP agents based on plan preferences, copay status, and prescriber experience.

Competition-driven dynamics

• Class competition from oral CGRP antagonists: Ubrogepant faces head-to-head pricing and coverage competition from Eli Lilly’s zavegepant (intranasal CGRP), and from other oral CGRP options including Nurtec ODT (rimegepant) and Reyvow (lasmiditan) in some payer landscapes. Treatment switching occurs when payers prefer certain molecules, when patient assistance changes the net cost, or when clinical workflow favors a specific administration profile.
• Intranasal CGRP and non-CGRP options: Zavegepant’s positioning can shift demand toward intranasal options during periods when payers steer patients to alternatives perceived as easier to administer.

How does the market structure shape growth and pricing?

Channel and access mechanics

• Specialty vs retail/mail distribution: Migraine acute drugs usually enter through specialty pharmacy networks, then migrate toward broader channels as plans standardize coverage.
• Utilization management: Prior authorization and step therapy can slow early uptake and create volatility in monthly demand, especially when plan formularies update mid-contract.
• Patient assistance and net pricing: Large real-world variability in net price comes from rebates, copay assistance, and contract-specific terms. Public figures can understate actual realized price shifts due to payer rebates and patient support spend.

Pricing and net revenue

• List price vs realized revenue: For branded acute migraine therapies, list price is only a starting point. Net revenue reflects rebates, manufacturer discounts, and pharmacy benefit manager (PBM) dynamics.
• Negotiated contract cadence: Realized revenue tends to track formulary renewals and annual contract renegotiations, creating step-changes around policy renewal windows.

What is the financial trajectory for ubrogepant (Ubrelvy) in the public record?

Corporate reporting: AbbVie and partner context

Ubrogepant is marketed as Ubrelvy by AbbVie. AbbVie reports revenues by product and segment in periodic filings. Ubrogepant’s financial path has been reported alongside its migraine portfolio and broader neuroscience development pipeline.

Revenue trajectory pattern (typical for oral migraine products)

In acute migraine franchise development, financial trajectories generally follow these phases:

1. Launch ramp: growth driven by early prescriber adoption and initial commercial coverage.
2. Managed-care stabilization: growth becomes more dependent on payer refresh cycles and plan-specific formulary placements.
3. Competitive share changes: oral CGRP competition and administration preferences drive incremental share shifts and can compress pricing power.
4. Portfolio optimization: promotional intensity and support programs adjust to defend retention and capture new patients.

Because the question is market dynamics and financial trajectory, the relevant investor view is realized demand and net sales behavior, not clinical differentiation. For ubrogepant, the market lens has consistently centered on access and switching among CGRP-branded therapies.

Where does ubrogepant sit in the competitive set?

Competitive adjacency in acute migraine

Ubrogepant competes with:

• Other oral CGRP receptor antagonists (notably rimegepant).
• Intranasal CGRP options (notably zavegepant) in payer landscapes that value administration convenience.
• Non-CGRP acute migraine agents (including serotonin receptor agonists), depending on plan design and formulary constraints.

How this affects unit economics

• Formulary consolidation favors fewer products: As payers finalize preferred lists, brands must either secure preferred placement or compete through coverage exceptions and patient support.
• Copay assistance changes effective affordability: When one molecule becomes the preferred option, other oral CGRP agents see utilization pressure unless they offset with net price support.

What outcomes matter most for future financial performance?

1) Persistence and repeat-use behavior

Acute migraine drugs benefit from repeated monthly use in diagnosed migraine patients. Financial performance correlates with:

• patient retention (continued use over months),
• refill behavior (pharmacy persistence),
• and switching thresholds (when a patient tries a different acute agent).

2) Dosing convenience and guideline alignment

Acute migraine real-world adoption depends on prescriber comfort with dosing schedules and patient workflow fit. Any changes that reduce perceived complexity support retention.

3) Access under Medicare Part D and employer plans

Large payer channels are where financial trajectory is set:

• preferred formulary status,
• prior authorization criteria,
• and quantity limits.

4) Competitive repositioning within AbbVie’s portfolio

AbbVie’s migraine strategy has included portfolio management and expansion. In practice, it affects ubrogepant demand through shared detailing resources, payer negotiation leverage, and combined contracting narratives for the full migraine line.

Market dynamics timeline (how competitive and coverage forces tend to play out)

The migraine acute market typically evolves through predictable policy patterns:

• Contract negotiation windows: annual and semi-annual revisions can cause short-term demand swings.
• Payer therapeutic class changes: CGRP classes often see periodic formulary re-optimization, leading to access expansion or restriction.
• Copay program adjustments: net affordability can shift when competition intensifies.

Ubrogepant’s financial trajectory should be read through these lenses: share gains or losses are most likely when coverage terms change and when competitors secure preferred access.

Key risk factors to the financial outlook

• Preferred formulary loss: even modest changes to tier placement or PA criteria can reduce new starts and continuation.
• Competitive net price compression: as PBM contracting tightens, brands often reduce realized pricing to retain share.
• Switching toward favored administration: if intranasal or alternative dosing profiles win payer preference, oral CGRP share can soften.
• Utilization management tightening: more restrictive step edits can create demand volatility.

What to watch next (investor-grade checkpoints)

Payer and channel signals

• formulary status updates in top PBMs,
• migration from specialty to broader channels,
• and PA policy changes that indicate tightening or loosening.

Competitive signals

• net price actions and increased rebate intensity across oral CGRP competitors,
• and shifts in copay assistance that affect patient uptake.

Company-specific signals

• AbbVie product-level disclosure on migraine franchise performance in periodic reporting,
• and commentary on growth drivers and market access.

Key Takeaways

• Ubrogepant’s market dynamics are dominated by payer access and competitive switching within the acute migraine CGRP landscape, not by a single clinical lever.
• Financial trajectory follows a coverage-driven ramp, then managed-care stabilization, and then share and net revenue pressure as oral and non-oral CGRP competitors negotiate preferred positions.
• Near-term outcomes depend on formulary placement, utilization management (PA/step edits), patient persistence, and net price vs copay support economics.
• The central investor KPI is realized demand and net sales performance through contract cycles in major employer and Medicare Part D channels.

FAQs

1) What is ubrogepant’s branded product name?

Ubrogepant is marketed as Ubrelvy by AbbVie.

2) What class does ubrogepant belong to in migraine?

Ubrogepant is a CGRP receptor antagonist used for acute migraine treatment.

3) What drives ubrogepant’s share changes most often?

Most share shifts occur from formulary status changes, prior authorization policies, and switching within oral CGRP competitors.

4) How do PBMs affect ubrogepant financial results?

PBMs influence net pricing through contracting terms, rebates, and preferred formulary placement that shape realized revenue.

5) What is the most important near-term metric for financial trajectory?

The most important metric is product-level net sales (or realized revenue) trend, tracked across payer and channel access changes over contract cycles.

References

[1] AbbVie Inc. Annual Report on Form 10-K (latest available period).
[2] AbbVie Inc. Quarterly Report on Form 10-Q (most recent available period).
[3] FDA Prescribing Information: Ubrelvy (ubrogepant).