NATAZIA
· 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 |
|---|---|---|---|---|---|---|---|---|
| 8071577 | 2026-05-13 | DP/U U-1 | N | N | REGIMEN_PARTIAL_USE | — | — | — |
| 8071577 | 2026-05-13 | DP/U U-1 | N | N | REGIMEN_PARTIAL_USE Independent claim 3 covers the approved multiphase oral contraceptive regimen, but not the separate heavy-menstrual-bleeding treatment indication. Joint coverage with US8153616 evaluated separately. | — | — | — |
| 8153616 | 2028-01-30 | U U-1240 | N | N | REGIMEN_PARTIAL_USE | — | — | — |
| 8153616 | 2028-01-30 | U U-1240 | N | N | REGIMEN_PARTIAL_USE Independent claims 1, 3 and 5 cover dysfunctional uterine bleeding with the approved multiphase regimen; contraception-only users are outside the bleeding requirement. Joint coverage with US8071577 evaluated separately. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2010-05-06 | 2013-05-06 | Original estradiol-valerate/dienogest multiphase oral contraceptive product; separate later heavy-menstrual-bleeding use evaluated in a union. | N | N | — | NP + I-648
Full coverage date: —
| Source |
| I-648 | 2012-03-14 | 2015-03-14 | TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION | N | N | — | NP + I-648
Full coverage date: —
| 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 |
|---|---|---|---|---|---|---|---|
| 202349 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | WATSON LABS INC | 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 (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2026-05-13 | LISTING_CONTEXT | Independent claim 3 covers the approved multiphase oral contraceptive regimen, but not the separate heavy-menstrual-bleeding treatment indication. Joint coverage with US8153616 evaluated separately. | Source |
| PATENT | 2028-01-30 | FTO_TAIL | Independent claims 1, 3 and 5 cover dysfunctional uterine bleeding with the approved multiphase regimen; contraception-only users are outside the bleeding requirement. Joint coverage with US8071577 evaluated separately. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | Original estradiol-valerate/dienogest multiphase oral contraceptive product; separate later heavy-menstrual-bleeding use evaluated in a union. | Source |
| REGULATORY_EXCLUSIVITY | — | SCOPE_CONTEXT | TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION | Source |
| REGULATORY_STATUS | 2026-05-13 | DECISION_BASIS | Rights after the canonical full-scope anchor require DEEP_REVIEW. | Source |
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.