CONTRAVE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
GNR judgment: DEEP_REVIEW. Reference year: 2024. Anchor type: DRUG_SUBSTANCE. Patent anchor: 2024-04-21. Exclusivity anchor: 2017-09-10. Anchor date: 2024-04-21. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. 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 |
|---|---|---|---|---|---|---|---|---|
| 9107837 | 2027-06-04 | U U-1639 | — | — | — | — | — | — |
| 10307376 | 2027-11-08 | U U-1585 | — | — | — | — | — | — |
| 12048769 | 2027-11-08 | U U-1585 | — | — | — | — | — | — |
| 8318788 | 2027-11-08 | U U-1584 | — | — | — | — | — | — |
| 8722085 | 2027-11-08 | U U-1585 | — | — | — | — | — | — |
| 9125868 | 2027-11-08 | U U-1585 | — | — | — | — | — | — |
| 8088786 | 2029-02-03 | DP — | — | — | — | — | — | — |
| 11324741 | 2029-05-29 | U U-1583 | — | — | — | — | — | — |
| 8916195 | 2030-02-02 | U U-1639 | — | — | — | — | — | — |
| 11033543 | 2031-01-10 | U U-1583 | — | — | — | — | — | — |
| 9248123 | 2032-01-13 | U U-1808 | — | — | — | — | — | — |
| 10403170 | 2033-06-05 | U U-1583 | — | — | — | — | — | — |
| 11139056 | 2033-06-05 | U U-1583 | — | — | — | — | — | — |
| 9633575 | 2033-06-25 | U U-1583 | — | — | — | — | — | — |
| 10231964 | 2034-07-02 | U U-1583 | — | — | — | — | — | — |
| 10828294 | 2034-07-02 | U U-1583 | — | — | — | — | — | — |
| 10835527 | 2034-07-02 | U U-1583 | — | — | — | — | — | — |
| 11998542 | 2034-07-02 | U U-1583 | — | — | — | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| No exclusivity facts are recorded in this product snapshot. | ||||||||
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 |
|---|---|---|---|---|---|---|---|
| 208043 / 001 | TENTATIVE_APPROVAL · TENTATIVE_APPROVAL | — | 2022-11-29 | Actavis Laboratories FL, Inc. | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | 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 1 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 |
|---|---|---|---|---|---|---|---|
| 208043 / 001 | Actavis Laboratories FL, Inc. | TENTATIVE_APPROVAL · TENTATIVE_APPROVAL | 2022-11-29 | No final approval linked | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
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. | ||||||
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 |
|---|---|---|---|---|---|
| 2019-08-15 | Nalpropion Pharmaceuticals / Orexigen / Takeda v. Actavis Laboratories FL | LITIGATION Brand-level record; strength scope not established
|
Not disclosed | SOURCE_CONFIRMED | Source |
| Federal Circuit No. 18-1221; underlying D. Del. No. 1:15-cv-451. Decision affirmed validity/not-invalidity outcome for claim 11 of US8916195 but reversed lower-court nonobviousness holdings for claim 1 of US7375111 and claims 26,31 of US7462626. Mandate entered 2019-12-23. FDA 2022 tentative letter recounts ANDA 208043 approval restriction to 2030-02-02 on US8916195. Not a negotiated generic launch date. | |||||