Product profile · United States
BALVERSA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
POST_ANCHOR_RIGHTS_EXIST; US:NDA:212018:003; exact Final ANDA not verified; not proof of generic absence
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 9464071 | 2031-04-28 | U U-3805 | N | Y | U English description not available. | — | — | — |
| 9464071 | 2031-04-28 | ORANGE_BOOK U-3805 | N | Y | U English description not available. | — | — | — |
| 8895601 | 2033-04-12 | DS/DP — | Y | N | TRUE_DS English description not available. | — | — | — |
| 8895601 | 2033-04-12 | ORANGE_BOOK — | Y | N | TRUE_DS English description not available. | — | — | — |
| 9902714 | 2035-03-26 | DP — | N | N | OTHER English description not available. | — | — | — |
| 9902714 | 2035-03-26 | ORANGE_BOOK — | N | N | OTHER English description not available. | — | — | — |
| 12037644 | 2035-10-18 | U U-3972 | N | N | U English description not available. | — | — | — |
| 12037644 | 2035-10-18 | ORANGE_BOOK U-3972 | N | N | U English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3066 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3067 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3805 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3065 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3806 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-3807 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | DP/U U-2518 | N | N | DP English description not available. | — | — | — |
| 10898482 | 2036-02-09 | ORANGE_BOOK U-2518,U-3065,U-3066,U-3067,U-3805,U-3806,U-3807 | N | N | DP English description not available. | — | — | — |
| 11684620 | 2036-02-09 | U U-3807 | N | N | U English description not available. | — | — | — |
| 11684620 | 2036-02-09 | U U-3806 | N | N | U English description not available. | — | — | — |
| 11684620 | 2036-02-09 | U U-3805 | N | N | U English description not available. | — | — | — |
| 11684620 | 2036-02-09 | ORANGE_BOOK U-3805,U-3806,U-3807 | N | N | U English description not available. | — | — | — |
| 12678498 | 2036-06-13 | U U-4584 | N | N | U English description not available. | — | — | — |
| 12678498 | 2036-06-13 | ORANGE_BOOK U-4584 | N | N | U English description not available. | — | — | — |
| 10478494 | 2036-08-13 | U U-3902 | N | N | U English description not available. | — | — | — |
| 10478494 | 2036-08-13 | ORANGE_BOOK U-3902 | N | N | U English description not available. | — | — | — |
| 11077106 | 2038-02-02 | U U-3808 | N | N | U English description not available. | — | — | — |
| 11077106 | 2038-02-02 | U U-3196 | N | N | U English description not available. | — | — | — |
| 11077106 | 2038-02-02 | ORANGE_BOOK U-3196,U-3808 | N | N | U English description not available. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2019-04-12 | 2024-04-12 | English description not available. | Y | Y | 2024-04-12 | I-930
Full coverage date: 2024-04-12
| Source |
| I-930 | 2024-01-19 | 2027-01-19 | English description not available. | Y | Y | 2027-01-19 | — | Source |
| I-930 | 2024-01-19 | 2027-01-19 | English description not available. | Y | Y | 2027-01-19 | I-930
Full coverage date: 2027-01-19
| 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. | ||||||
Decision evidence (12)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2031-04-28 | HISTORICAL_CONTEXT | English description not available. | Source |
| PATENT | 2033-04-12 | CANONICAL_ANCHOR | English description not available. | Source |
| PATENT | 2035-03-26 | FTO_TAIL | English description not available. | Source |
| PATENT | 2035-10-18 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-02-09 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-06-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2036-08-13 | FTO_TAIL | English description not available. | Source |
| PATENT | 2038-02-02 | FTO_TAIL | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_EXCLUSIVITY | — | REGULATORY_SCOPE_CONTEXT | English description not available. | Source |
| REGULATORY_STATUS | 2033-04-12 | CANONICAL_DECISION | POST_ANCHOR_RIGHTS_EXIST; US:NDA:212018:003; exact Final ANDA not verified; not proof of generic absence | 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.