Product profile · United States
AUVELITY
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2034. Anchor type: DS_EQUIVALENT. Patent anchor: 2034-11-05. Exclusivity anchor: not recorded. Anchor date: 2034-11-05. Patent tail: yes. Exclusivity tail: no. Review status: FINAL_CHECKING. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8569328 | 2032-07-18 | DP/U U-4516 | — | — | — | — | — | — |
| 8569328 | 2032-07-18 | DP/U U-3419 | — | — | — | — | — | — |
| 10058518 | 2034-11-05 | U U-4522 | — | — | — | — | — | — |
| 10058518 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10064857 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10064857 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10080727 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10080727 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 10092560 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10092560 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10092561 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10092561 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10105327 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10105361 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10105361 | 2034-11-05 | U U-4522 | — | — | — | — | — | — |
| 10251879 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10251879 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10463634 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10463634 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10512643 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10512643 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10548857 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10596167 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10596167 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10772850 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10780066 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10780066 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10786469 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10786496 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10786496 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10799497 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10806710 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10806710 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10864209 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10874663 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10874664 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10874665 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10881624 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10881624 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10881657 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10894046 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10894047 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10898453 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10933034 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10945973 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10966941 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 10966941 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10966974 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11007189 | 2034-11-05 | U U-4516 | — | — | — | — | — | — |
| 11020389 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11058648 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11065248 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11065248 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11090300 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11096937 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11123343 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11123344 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11123344 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11129826 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11141388 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11141416 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11147808 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11185515 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11191739 | 2034-11-05 | DP/U U-3419 | — | — | — | — | — | — |
| 11191739 | 2034-11-05 | DP/U U-4516 | — | — | — | — | — | — |
| 11197839 | 2034-11-05 | DP/U U-4516 | — | — | — | — | — | — |
| 11197839 | 2034-11-05 | DP/U U-3419 | — | — | — | — | — | — |
| 11207281 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11207281 | 2034-11-05 | U U-4537 | — | — | — | — | — | — |
| 11213521 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11229640 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11234946 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11234946 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11253491 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11253492 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11253492 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11273133 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11273133 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11273134 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11273134 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11285118 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11285118 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11285146 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11285146 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11291638 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11291638 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11291665 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11291665 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11298351 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11298352 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11298352 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11311534 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11344544 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11344544 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11357744 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11357744 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11364233 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11382874 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11382874 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11419867 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11419867 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11426370 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11426370 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11426401 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11426401 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11433067 | 2034-11-05 | DP/U U-4516 | — | — | — | — | — | — |
| 11433067 | 2034-11-05 | DP/U U-3419 | — | — | — | — | — | — |
| 11439636 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11439636 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 11478468 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11497721 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11510918 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11517542 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11517543 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11524007 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11524008 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11534414 | 2034-11-05 | DP/U U-3419 | — | — | — | — | — | — |
| 11534414 | 2034-11-05 | DP/U U-4516 | — | — | — | — | — | — |
| 11541021 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11541048 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11571417 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11571417 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11576909 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11576909 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11590124 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11590124 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11596627 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11617728 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11617747 | 2034-11-05 | U U-3563 | — | — | — | — | — | — |
| 11617747 | 2034-11-05 | U U-4526 | — | — | — | — | — | — |
| 11779579 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 11969421 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 12109178 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9168234 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9168234 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9198905 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9198905 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 9205083 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 9205083 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9238032 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 9238032 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9278095 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9278095 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9314462 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9314462 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9370513 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 9370513 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9375429 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9375429 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9408815 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9408815 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9421176 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9421176 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9457023 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9457023 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9457025 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9457025 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9474731 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9474731 | 2034-11-05 | U U-4520 | — | — | — | — | — | — |
| 9486450 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9486450 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9700528 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9700528 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9700553 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9700553 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9707191 | 2034-11-05 | U U-4522 | — | — | — | — | — | — |
| 9707191 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9763932 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9763932 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9861595 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9861595 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9867819 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9867819 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 9968568 | 2034-11-05 | U U-4517 | — | — | — | — | — | — |
| 9968568 | 2034-11-05 | U U-3419 | — | — | — | — | — | — |
| 10780064 | 2040-01-07 | U U-3419 | — | — | — | — | — | — |
| 10925842 | 2040-01-07 | U U-3419 | — | — | — | — | — | — |
| 10940124 | 2040-01-07 | U U-3419 | — | — | — | — | — | — |
| 10966942 | 2040-01-07 | U U-3419 | — | — | — | — | — | — |
| 12433884 | 2040-06-05 | U U-4514 | — | — | — | — | — | — |
| 12472156 | 2040-06-05 | U U-4516 | — | — | — | — | — | — |
| 12576078 | 2040-06-05 | U U-4516 | — | — | — | — | — | — |
| 11896563 | 2041-12-01 | U U-3419 | — | — | — | — | — | — |
| 12390428 | 2041-12-01 | U U-3419 | — | — | — | — | — | — |
| 11717518 | 2043-01-20 | U U-3419 | — | — | — | — | — | — |
| 11925636 | 2043-01-20 | U U-3419 | — | — | — | — | — | — |
| 12156914 | 2043-01-20 | DP — | — | — | — | — | — | — |
| 12239642 | 2043-01-20 | U U-4515 | — | — | — | — | — | — |
| 12263161 | 2043-01-20 | U U-4515 | — | — | — | — | — | — |
| 12310961 | 2043-01-20 | U U-3419 | — | — | — | — | — | — |
| 12357697 | 2043-01-20 | U U-3419 | — | — | — | — | — | — |
| 12472174 | 2043-01-20 | U U-4515 | — | — | — | — | — | — |
| 12478622 | 2043-01-20 | U U-4515 | — | — | — | — | — | — |
| 12564587 | 2043-01-20 | U U-4515 | — | — | — | — | — | — |
| 12661408 | 2043-01-20 | U U-3419 | — | — | — | — | — | — |
| 12678506 | 2043-01-20 | DP — | — | — | — | — | — | — |
| 11730706 | 2043-01-23 | U U-3419 | — | — | — | — | — | — |
| 11883373 | 2043-01-23 | U U-3419 | — | — | — | — | — | — |
| 12194005 | 2043-01-23 | U U-4523 | — | — | — | — | — | — |
| 12364674 | 2043-01-23 | U U-4516 | — | — | — | — | — | — |
| 11986444 | 2043-02-15 | U U-3419 | — | — | — | — | — | — |
| 12036191 | 2043-02-15 | U U-3419 | — | — | — | — | — | — |
| 12370154 | 2043-02-15 | U U-4518 | — | — | — | — | — | — |
| 12599576 | 2043-02-15 | U U-4518 | — | — | — | — | — | — |
| 11752144 | 2043-02-23 | U U-3419 | — | — | — | — | — | — |
| 12042473 | 2043-02-23 | U U-3419 | — | — | — | — | — | — |
| 12146889 | 2043-02-23 | U U-3419 | — | — | — | — | — | — |
| 12472155 | 2043-02-23 | U U-4519 | — | — | — | — | — | — |
| 11839612 | 2043-03-02 | U U-3419 | — | — | — | — | — | — |
| 11844797 | 2043-04-20 | U U-3778 | — | — | — | — | — | — |
| 12194036 | 2043-04-20 | U U-4521 | — | — | — | — | — | — |
| 12653795 | 2043-11-28 | U U-4516 | — | — | — | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| I-913 | — | 2029-04-30 | — | — | — | — | Source |
2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE
Generic approval evidence
| Application / product | Event | Final date | Tentative date | Applicant | Authorized generic | Exact mapping | Source |
|---|---|---|---|---|---|---|---|
| No generic approval facts are linked to this product. | |||||||
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. | ||||||
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.
| Event date | Party | Event | Licensed entry | Evidence | Source |
|---|---|---|---|---|---|
| 2025-02-01 | Teva | SETTLEMENT Brand-level record; strength scope not established
|
2038-09 | REVIEW | — |
| Pediatric-exclusivity contingency; 2039-03 potential alternative; verify | |||||