Product profile · United States
SLYND
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
No listed patent or regulatory-exclusivity right remains after the canonical full-scope anchor.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10179140 | 2031-06-28 | U U-2553 | N | N | LIMITED_USE | — | — | — |
| 10179140 | 2031-06-28 | U U-2553 | N | N | LIMITED_USE Drospirenone contraception restricted to BMI at least 25 and bleeding outcomes; not all reproductive-potential patients. | — | — | — |
| 10603281 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE | — | — | — |
| 10603281 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE Contraception with a drospirenone formulation having specified binder, filler, glidant and lubricant ranges. | — | — | — |
| 10849857 | 2031-06-28 | DP/U U-2553 | N | N | FORMULATION | — | — | — |
| 10849857 | 2031-06-28 | DP/U U-2553 | N | N | FORMULATION Drospirenone particle-size, excipient proportion and dissolution restrictions; contraception claims depend on that formulation. | — | — | — |
| 10987364 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 10987364 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone particle-size distribution, estrogen exclusion and slow-dissolution requirements. | — | — | — |
| 11123299 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11123299 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone particle-size distribution and dissolution restrictions. | — | — | — |
| 11291632 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11291632 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone particle-size distribution and dissolution restrictions. | — | — | — |
| 11291633 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11291633 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone median particle size and dissolution restrictions. | — | — | — |
| 11351122 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11351122 | 2031-06-28 | DP — | N | N | FORMULATION Estrogen-free drospirenone composition constrained by PK and dissolution values. | — | — | — |
| 11413249 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE | — | — | — |
| 11413249 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE 24/4 contraceptive regimen requires specified drospirenone PK and slow-dissolution formulation. | — | — | — |
| 11478487 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11478487 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone particle size, PK and dissolution requirements. | — | — | — |
| 11504334 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 11504334 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone sub-10-micron particles with PK and slow-dissolution requirements. | — | — | — |
| 11951213 | 2031-06-28 | U U-2553 | N | Y | DS_EQUIVALENT | — | — | — |
| 11951213 | 2031-06-28 | U U-2553 | N | Y | DS_EQUIVALENT Estrogen-free drospirenone 2-6 mg 24/4 contraception regimen without formulation restriction; permits specified delayed doses while maintaining efficacy. Covers the approved 4 mg 24/4 indication and patient scope. | — | — | — |
| 12090231 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE | — | — | — |
| 12090231 | 2031-06-28 | U U-2553 | N | N | FORMULATION_USE Drospirenone 24/4 regimen with missed-dose allowance is constrained by quantitative PK requirements. | — | — | — |
| 12280151 | 2031-06-28 | DP — | N | N | FORMULATION | — | — | — |
| 12280151 | 2031-06-28 | DP — | N | N | FORMULATION Drospirenone 4 mg tablet with PK and slow-dissolution restrictions. | — | — | — |
| 9603860 | 2031-06-28 | U U-2553 | N | N | LIMITED_USE | — | — | — |
| 9603860 | 2031-06-28 | U U-2553 | N | N | LIMITED_USE Drospirenone contraception restricted to BMI at least 30 and bleeding outcomes. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NP | 2019-05-23 | 2022-05-23 | New estrogen-free 4 mg drospirenone 24/4 product for the single approved contraception use in females of reproductive potential. | Y | Y | 2022-05-23 | 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 |
|---|---|---|---|---|---|---|---|
| 216936 / 001 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | LUPIN LTD | 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 (17)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone median particle size and dissolution restrictions. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone contraception restricted to BMI at least 30 and bleeding outcomes. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Estrogen-free drospirenone composition constrained by PK and dissolution values. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | 24/4 contraceptive regimen requires specified drospirenone PK and slow-dissolution formulation. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone 24/4 regimen with missed-dose allowance is constrained by quantitative PK requirements. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone particle-size distribution, estrogen exclusion and slow-dissolution requirements. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Contraception with a drospirenone formulation having specified binder, filler, glidant and lubricant ranges. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone contraception restricted to BMI at least 25 and bleeding outcomes; not all reproductive-potential patients. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone sub-10-micron particles with PK and slow-dissolution requirements. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone 4 mg tablet with PK and slow-dissolution restrictions. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone particle-size distribution and dissolution restrictions. | Source |
| PATENT | 2031-06-28 | CANONICAL_ANCHOR | Estrogen-free drospirenone 2-6 mg 24/4 contraception regimen without formulation restriction; permits specified delayed doses while maintaining efficacy. Covers the approved 4 mg 24/4 indication and patient scope. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone particle size, PK and dissolution requirements. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone particle-size, excipient proportion and dissolution restrictions; contraception claims depend on that formulation. | Source |
| PATENT | 2031-06-28 | LISTING_CONTEXT | Drospirenone particle-size distribution and dissolution restrictions. | Source |
| REGULATORY_EXCLUSIVITY | 2022-05-23 | CANONICAL_ANCHOR | New estrogen-free 4 mg drospirenone 24/4 product for the single approved contraception use in females of reproductive potential. | Source |
| REGULATORY_STATUS | 2031-06-28 | DECISION_BASIS | No listed patent or regulatory-exclusivity right remains after the canonical full-scope anchor. | 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.