CLINICAL TRIALS PROFILE FOR UBRELVY

All Clinical Trials for ubrelvy

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04818515 ↗	Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine	Completed	Allergan	Phase 1	2021-03-17	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
NCT05125302 ↗	Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)	Not yet recruiting	Allergan	Phase 3	2021-11-09	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT05127954 ↗	Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)	Not yet recruiting	Allergan	Phase 3	2021-11-12	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 103 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
NCT05214001 ↗	Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine	Not yet recruiting	Messoud Ashina, MD	Phase 4	2022-02-01	In a real-world population of adults with migraine, the investigators would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake.
NCT05264129 ↗	Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine	Not yet recruiting	Allergan	Phase 4	2022-04-01	Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT05503082 ↗	Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies	Not yet recruiting	AbbVie	Phase 4	2022-08-01	This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.
NCT05503082 ↗	Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies	Not yet recruiting	Chicago Headache Center & Research Institute	Phase 4	2022-08-01	This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Clinical Trial Conditions for ubrelvy

Condition Name

Condition Name for ubrelvy
Intervention	Trials
Migraine	3
Episodic Migraine	1
Headache, Migraine	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for ubrelvy
Intervention	Trials
Migraine Disorders	6
Migraine with Aura	1
Headache	1
Migraine without Aura	1

Clinical Trial Locations for ubrelvy

Trials by Country

Trials by Country for ubrelvy
Location	Trials
United States	87
Denmark	1

Trials by US State

Trials by US State for ubrelvy
Location	Trials
Missouri	4
Florida	4
California	3
Utah	3
Texas	3

Clinical Trial Progress for ubrelvy

Clinical Trial Phase

Clinical Trial Phase for ubrelvy
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for ubrelvy
Clinical Trial Phase	Trials
Not yet recruiting	6
Completed	1

Clinical Trial Sponsors for ubrelvy

Sponsor Name

Sponsor Name for ubrelvy
Sponsor	Trials
Allergan	4
AbbVie	2
Messoud Ashina, MD	1

Sponsor Type

Sponsor Type for ubrelvy
Sponsor	Trials
Industry	6
Other	2

UBRELVY (ubrogepant) clinical trials update, market analysis, and launch-year projection through LOE

Last updated: July 26, 2026

UBRELVY (ubrogepant) is an oral calcitonin gene-related peptide (CGRP) receptor antagonist marketed by AbbVie and Allergan for acute treatment of migraine and prevention of recurrent migraine disability episodes. The brand has a defined regulatory and competitive footprint centered on U.S. oral gepants, with ongoing research focused on additional populations, dosing regimens, and combination strategies. Commercially, UBRELVY’s near- to mid-term trajectory is driven by CGRP class penetration, payer coverage, seasonality in migraine headwinds, and the share contest with Eli Lilly’s rimegepant (Nurtec ODT) and other oral CGRP agents, while longer-term risk is tied to patent expiration and biologic-free small-molecule competition.

---

What is UBRELVY (ubrogepant) FDA status and Orange Book exclusivity timeline?

Orange Book listing and protected product scope

UBRELVY is listed as a drug product in the FDA’s Orange Book (approved NDA), with exclusivity and patents tied to:

• Drug substance (ubrogepant)
• Drug product formulations and/or solid-state properties
• Method(s) of use (migraine-related indications, where applicable)
• Manufacturing/process claims, if listed

Regulatory exclusivity and patent term risk

Commercial exclusivity exposure in migraine small molecules typically clusters around:

• 3-year new clinical investigation exclusivity tied to specific supplemental claims
• 5-year data exclusivity tied to original approval or major line extensions
• Patent expiration and potential “skinny label” design-arounds under Paragraph IV settlements (if any)

Market implication of exclusivity structure

For UBRELVY, exclusivity and patent protection shape:

• Timing of first ANDA/generic entry for tablets
• Potential switch to “authorized generic” pathways
• Incentives for payer formulary placement of competing gepants before UBRELVY’s earliest generic risk date

---

What clinical trials update exists for UBRELVY (acute and prevention) and what endpoints matter?

UBRELVY is built on acute migraine efficacy and a distinct prevention indication through fixed dosing regimens. Trial updates for UBRELVY generally fall into three categories that translate into payer and clinician adoption:

1. Acute migraine endpoints
   Primary end points typically include 2-hour pain freedom and 2-hour pain relief, plus freedom from most bothersome symptom (MBS).

2. Preventive therapy endpoints
   For prevention, primary measures often include reduction in monthly migraine days (MMDs) or migraine attacks.

3. Population and dosing regimen expansions
   Studies tend to target:

   • Patients with inadequate response to prior acute therapy
   • Subgroups with comorbidities or earlier treatment failure
   • Longer-term safety and tolerability
   • Drug-drug interaction (DDI) and hepatic/renal handling in “real-world dosing” patterns

How trial results affect commercial projection

Clinically meaningful endpoints map directly to:

• Formulary justification (payer policy needs measurable reductions in MMDs or disability recurrence)
• Patient persistence (tolerability and DDI rules influence adherence)
• Switching behavior between UBRELVY and class peers (chiefly rimegepant)

---

Which UBRELVY clinical studies are most relevant for future label expansion?

Long-term safety and tolerability studies

Migraine drugs face persistence constraints driven by:

• Adverse event profile in repetitive use
• Rates of discontinuation due to tolerability
• Real-world adherence to dosing limits per day/month

Long-term studies also de-risk:

• Liver enzyme elevation concerns typical of small-molecule hepatic metabolism classes
• DDIs through CYP3A4 and P-gp transport interactions

Special population studies

Trials supporting label breadth often target:

• Moderate-to-severe renal impairment
• Mild to moderate hepatic impairment
• Concomitant medication burdens (antidepressants, antihypertensives, anticonvulsants)

Combination strategies

Combination studies are commercially relevant because they aim to:

• Integrate acute gepants with preventive monoclonal antibodies or oral preventives
• Reduce “step-up” time to effective acute rescue

---

When does UBRELVY lose exclusivity and what generic entry risks exist?

Generic entry scenarios

For oral CGRP antagonists like ubrogepant, generic risk typically depends on:

• Patent expiration for the NDA product and listed Orange Book patents
• Whether patents include method-of-use claims (higher litigation probability)
• Whether formulation patents prevent simple bioequivalence substitution

Paragraph IV pathway impact

If ANDA filers file Paragraph IV certifications for ubrogepant tablets:

• First filers can trigger 30-month stay
• Litigation and potential settlements can shift launch dates
• Authorized generics can compress net pricing even before full generic penetration

Timeline structure used for projection

Market projections typically segment into:

• Pre-LOE baseline (steady share with class competition)
• LOE ramp (generic availability or “authorized generic” pressure)
• Post-LOE compression (price erosion, payer switching, and higher volume dependence)

---

What formulations are protected for UBRELVY and how do they affect generic design-around?

UBRELVY is an oral tablet product. Patent estates that can block or delay generics usually cover:

• Solid-state and polymorph characteristics
• Dissolution profiles and bioavailability-enhancing excipients
• Film coatings and tablet geometry that support BE

Tablet formulation patent risk

Tablet formulation protection can delay generic substitution even when:

• API patents expire earlier
• BE is met in a purely pharmacokinetic sense

Manufacturing method patents

Method and process patents raise barriers when:

• The manufacturing workflow differs substantially from the reference product
• Critical steps are claimed (granulation, drying, compression parameters)

---

What patent litigation affects UBRELVY (Paragraph IV, settlements, injunction risk)?

For high-integrity exclusivity planning, the critical inputs are:

• Whether ANDA filers have filed for ubrogepant tablets
• The specific Orange Book patents asserted in each litigation
• Settlement terms (earliest generic launch date, carve-outs, co-promotion limits)
• Scope of injunction if the court issues a claim construction that favors the brand

Why litigation outcomes matter for revenue

Migraine drug revenues are sensitive to:

• Launch-year timing (calendar quarter effects on payer contracting)
• Settlement-triggered “switching certainty”
• Generic-to-brand price gap during formulary re-optimization

---

How strong is the patent estate for UBRELVY across jurisdictions?

UBRELVY’s U.S. estate typically matters most for:

• ANDA entry timing
• Injunction leverage
• Settlement economics

Jurisdictional strength in Europe and other markets can matter for:

• parallel import and pricing arbitrage
• global supply contracts for the API and finished product

Patent estate structure that drives strength

Strong estates generally include:

• Multiple overlapping composition and method-of-use patents
• Later-expiring patents that remain listed in the Orange Book
• Manufacturing/process claims that require more than simple formulation changes

---

How does UBRELVY compare with Nurtec ODT (rimegepant) on clinical and market factors?

Clinical differentiation

Both UBRELVY and Nurtec ODT are oral CGRP receptor antagonists, with commercial differentiation driven by:

• Dosing scheme (acute and preventive label use)
• Patient adherence and dosing convenience
• Safety and DDI rules that influence prescriber confidence

Market differentiation

The competitive set tends to be decided by:

• Payer coverage policies (preferred gepant selection)
• Specialty pharmacy contracting and patient support programs
• Per-claim reimbursement rates in commercial and Medicare Part D

Projection implication

Class competition affects:

• Uptake in “migraine after failure” channels
• Switching from one gepant to the other after partial response
• Growth ceiling in episodic migraine populations

---

What is the market size for oral gepants and where does UBRELVY sit?

Category dynamics

Oral gepants sit in the broader migraine acute and preventive market, competing with:

• Triptans and non-triptan acute therapies
• CGRP monoclonal antibodies and botulinum toxin for prevention
• Other oral preventives

The oral gepant category benefits from:

• Ease of use relative to injectables
• Rapid symptom relief positioning
• Clinician acceptance of non-vasoconstrictive acute therapy

UBRELVY market positioning

UBRELVY’s market share is influenced by:

• Formulary access in top commercial plans and PBMs
• Uptake in disability-relevant migraine profiles
• Speed of adoption in newly diagnosed or treatment-referral patients

---

Commercial forecast: UBRELVY revenue projection through loss of exclusivity

Projection framework

Revenue projection should be modeled using:

1. Base share growth from expanding treated populations
2. Class competition from rimegepant and other oral migraine agents
3. Payer contracting and net price trends
4. LOE probability distribution driven by patent/ANDA timing and settlements
5. Generic penetration intensity and time-to-substitution once available

Key forecast drivers

• Unit demand: prescriptions, refills, and persistence in recurrent migraine cohorts
• Net price: payer rebates and contract changes vs. class peers
• Formulary tiering: whether UBRELVY becomes preferred or restricted
• LOE/Generic threat: timing of first ANDA and subsequent entrants

Launch-year and LOE ramp mechanics

A typical LOE curve for small-molecule brands in the U.S.:

• initial generic or authorized generic entry pressures net price sharply in the first 2 to 4 quarters
• subsequent entrants widen price dispersion and increase switching velocity
• volume may partially offset pricing compression but rarely fully offsets net price declines

---

What risks could change the UBRELVY commercial path faster than expected?

Competitive risk

• Fast payer switching to a preferred oral gepant
• Clinical differentiation not translating into reimbursement advantage
• Increased brand advertising spend by class peers

Regulatory and safety risk

• New safety signals in long-term use
• Expanded or narrowed DDIs affecting eligibility
• Label changes tied to liver or renal subgroup restrictions

IP and litigation risk

• Early generic settlement with shorter-than-expected stay time
• Broad patent invalidation affecting multiple listed patents
• Narrow court rulings that reduce brand leverage even without full win

---

Key Takeaways

• UBRELVY’s commercial outlook depends on its role as an oral CGRP acute and preventive therapy within a tight class competition against Nurtec ODT (rimegepant).
• Clinical trial endpoints most likely to influence next label and market expansion are long-term safety, subgroup efficacy, and regimen convenience that drives payer confidence.
• The revenue risk inflects around LOE and any Paragraph IV-driven settlement timelines that govern the earliest ANDA/launch date and first-wave price compression.
• Competitive position is less about molecule superiority and more about formulary preference, net pricing under PBM contracting, and persistence in recurrent migraine populations.

---

FAQs

1) What patents protect ubrogepant tablets in the U.S. Orange Book?

UBRELVY is protected by a mix of composition, formulation, and method-of-use patents listed in the FDA Orange Book tied to its NDA product.

2) How does UBRELVY LOE timing impact payer formulary strategy?

Payers often pre-position preferred status and prior authorization pathways in anticipation of LOE-driven generic substitution to protect reimbursement budgets.

3) Are there UBRELVY generic risks from Paragraph IV ANDAs?

Generic risk depends on whether ANDA filers challenge the listed patents for ubrogepant tablets and whether settlements define an entry date earlier than full expiration.

4) How does UBRELVY compare with rimegepant for preventive migraine?

Both are oral CGRP receptor antagonists; the practical differentiation for adoption is label dosing regimen, tolerability, DDI constraints, and resulting payer coverage.

5) Which clinical trial endpoints most affect UBRELVY uptake for prevention?

Monthly migraine days reduction, disability-relevant response, and sustained tolerability across repeated dosing cycles are the decision metrics that influence clinician and payer adoption.

---

References

(No sources were provided in the prompt, and no external citations are included.)