Product profile · United States
UBRELVY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Rights after the canonical full-scope anchor require DEEP_REVIEW.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9499545 | 2031-11-10 | DS/DP/U U-2718 | Y | Y | TRUE_DS | — | — | — |
| 9499545 | 2031-11-10 | DS/DP/U U-2718 | Y | Y | TRUE_DS Independent claim 1 fixes X as carbon but retains the ubrogepant-compatible two pyridine nitrogens, trifluoroethyl, methyl and unsubstituted phenyl choices. Genus visually compared with US8912210 claim 1 and FDA structure. | — | — | — |
| 9833448 | 2031-11-10 | U U-2718 | N | Y | DS_EQUIVALENT | — | — | — |
| 9833448 | 2031-11-10 | U U-2718 | N | Y | DS_EQUIVALENT Independent claim 1 broadly treats migraine with the ubrogepant structure, visually verified; no aura, patient subgroup, formulation or dose limitation excludes the approved acute migraine scope. | — | — | — |
| 8754096 | 2032-07-19 | DS/DP/U U-2717 | Y | Y | TRUE_DS | — | — | — |
| 8754096 | 2032-07-19 | DS/DP/U U-2717 | Y | Y | TRUE_DS Independent claim 1 CGRP compound genus includes ubrogepant substituents with methyl and unsubstituted phenyl permitted; genus visually compared with FDA label structure. Attached PTE names QULIPTA/atogepant and is not transferred to UBRELVY. | — | — | — |
| 8912210 | 2033-12-23 | DS/DP — | Y | Y | TRUE_DS | — | — | — |
| 8912210 | 2033-12-23 | DS/DP — | Y | Y | TRUE_DS Independent claim 1 explicitly depicts ubrogepant or acceptable salts; visually matched FDA structure. Other species do not restrict claim 1. PTE specifically names UBRELVY and is already reflected in the listed expiry. | — | — | — |
| 10117836 | 2035-01-30 | DP — | N | N | FORMULATION | — | — | — |
| 10117836 | 2035-01-30 | DP — | N | N | FORMULATION Ubrogepant polymer extrudate tablet with disintegration and hardness restrictions. | — | — | — |
| 11925709 | 2035-01-30 | DP — | N | N | FORMULATION | — | — | — |
| 11925709 | 2035-01-30 | DP — | N | N | FORMULATION Ubrogepant extrudate tablet with polymer matrix, dispersing agent and disintegration system. | — | — | — |
| 12168004 | 2035-01-30 | DP — | N | N | FORMULATION | — | — | — |
| 12168004 | 2035-01-30 | DP — | N | N | FORMULATION Ubrogepant polymer-extrudate tablet with dispersing/disintegration system and under-five-minute disintegration requirement. | — | — | — |
| 12220408 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 12220408 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION Amorphous ubrogepant tablet and disintegration system with under-five-minute disintegration limit. | — | — | — |
| 12310953 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 12310953 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION Amorphous ubrogepant tablet with disintegration system and quantitative rapid-release limit. | — | — | — |
| 12458632 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 12458632 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION Amorphous ubrogepant tablet with disintegration system and rapid-release dissolution restriction. | — | — | — |
| 12458633 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION | — | — | — |
| 12458633 | 2035-01-30 | DP — | N | N | AMORPHOUS_FORMULATION Amorphous ubrogepant tablet with disintegration system and 22-minute disintegration requirement. | — | — | — |
| 12070450 | 2041-12-22 | U U-3992 | N | N | LIMITED_USE | — | — | — |
| 12070450 | 2041-12-22 | U U-3992 | N | N | LIMITED_USE Ubrogepant 100 mg acute migraine therapy limited to concurrent weak/moderate CYP3A4 inducer users. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-12-23 | 2024-12-23 | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Y | Y | 2024-12-23 | Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| 219218 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | MSN LABORATORIES PRIVATE LIMITED | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
Market Entry Information
API filings, authorized generics and linked regulatory milestones.
API Master Files & Certifications 0 records
Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.
| API | Holder / manufacturer | Holder country | Filing type | Number | Status | Filed date | Available for reference | Source | Last verified |
|---|---|---|---|---|---|---|---|---|---|
| No master-file or certification records are linked through public manufacturer portfolios. | |||||||||
Authorized Generics 0 records
Authorized generics are shown separately from independent ANDA approvals.
| Application / product | Applicant | Event / status | First marketed | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No authorized-generic records are linked to this product. | ||||||
Tentative ANDA Approvals 0 records
Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.
| Application / product | Applicant | Event / status | Tentative date | Follow-up final approval | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|---|
| No tentative-approval records are linked to this product. | |||||||
Paragraph IV Challenges 0 records
Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.
| Application / product | Applicant | Event / status | Certification event date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No structured Paragraph IV certification events are linked in the available approval evidence. | ||||||
Final ANDA Approvals 0 records
Approval dates do not establish commercial launch. Product mapping is shown for each linked record.
| Application / product | Applicant | Event / status | Final approval date | Product mapping | Source | Last verified |
|---|---|---|---|---|---|---|
| No final-approval records are linked to this product. | ||||||
Decision evidence (14)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2031-11-10 | LISTING_CONTEXT | Independent claim 1 broadly treats migraine with the ubrogepant structure, visually verified; no aura, patient subgroup, formulation or dose limitation excludes the approved acute migraine scope. | Source |
| PATENT | 2031-11-10 | LISTING_CONTEXT | Independent claim 1 fixes X as carbon but retains the ubrogepant-compatible two pyridine nitrogens, trifluoroethyl, methyl and unsubstituted phenyl choices. Genus visually compared with US8912210 claim 1 and FDA structure. | Source |
| PATENT | 2032-07-19 | LISTING_CONTEXT | Independent claim 1 CGRP compound genus includes ubrogepant substituents with methyl and unsubstituted phenyl permitted; genus visually compared with FDA label structure. Attached PTE names QULIPTA/atogepant and is not transferred to UBRELVY. | Source |
| PATENT | 2033-12-23 | CANONICAL_ANCHOR | Independent claim 1 explicitly depicts ubrogepant or acceptable salts; visually matched FDA structure. Other species do not restrict claim 1. PTE specifically names UBRELVY and is already reflected in the listed expiry. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Ubrogepant polymer extrudate tablet with disintegration and hardness restrictions. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Amorphous ubrogepant tablet with disintegration system and quantitative rapid-release limit. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Amorphous ubrogepant tablet and disintegration system with under-five-minute disintegration limit. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Ubrogepant polymer-extrudate tablet with dispersing/disintegration system and under-five-minute disintegration requirement. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Amorphous ubrogepant tablet with disintegration system and 22-minute disintegration requirement. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Amorphous ubrogepant tablet with disintegration system and rapid-release dissolution restriction. | Source |
| PATENT | 2035-01-30 | FTO_TAIL | Ubrogepant extrudate tablet with polymer matrix, dispersing agent and disintegration system. | Source |
| PATENT | 2041-12-22 | FTO_TAIL | Ubrogepant 100 mg acute migraine therapy limited to concurrent weak/moderate CYP3A4 inducer users. | Source |
| REGULATORY_EXCLUSIVITY | 2024-12-23 | CANONICAL_ANCHOR | Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period. | Source |
| REGULATORY_STATUS | 2033-12-23 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | Source |
Independent legal-event information
Litigation & Settlement History
Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.
No litigation or settlement record currently linked to this product.