Product profile · United States
DRIZALMA SPRINKLE
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Available evidence does not establish a full-scope DS/DS-equivalent or full-coverage exclusivity anchor; approval-year DEEP_REVIEW is proposed. Direct Final-ANDA linkage may change the result.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 10413525 | 2037-04-13 | DP — | N | N | FORMULATION | — | — | — |
| 10413525 | 2037-04-13 | DP — | N | N | FORMULATION Claim 1: duloxetine sprinkle inert core/drug layer/enteric coat, specific cushioning layer, and ethanol dissolution limitations. | — | — | — |
| 10959982 | 2037-04-13 | DP — | N | N | FORMULATION | — | — | — |
| 10959982 | 2037-04-13 | DP — | N | N | FORMULATION Claim 1: duloxetine sprinkle inert core/drug layer/enteric coat and 1-naphthol <=15% after six hours under acidic conditions. | — | — | — |
| 11202772 | 2037-04-13 | DP — | N | N | FORMULATION | — | — | — |
| 11202772 | 2037-04-13 | DP — | N | N | FORMULATION Claims 1/5: drug core/enteric coat with impurity and alcohol-dissolution limitations. | — | — | — |
| 12171742 | 2037-04-13 | DP — | N | N | FORMULATION | — | — | — |
| 12171742 | 2037-04-13 | DP — | N | N | FORMULATION Claims 1-4: sprinkle core/enteric coat with acid resistance, impurity, alcohol dissolution, and soft-food stability limitations. | — | — | — |
| 9839626 | 2037-04-13 | DP — | N | N | FORMULATION | — | — | — |
| 9839626 | 2037-04-13 | DP — | N | N | FORMULATION Independent claims 1/14/16: inert core/drug layer, enteric coating 18-25%, polymer 75-99%, finishing layer, and 1-naphthol <=10% after six acidic hours, or fixed composition/strength. TRUE_DS N; DS-equivalent N. | — | — | — |
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 · CURRENT_SNAPSHOT_NO_RECORD · 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 |
|---|---|---|---|---|---|---|---|
| 090694 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090745 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090774 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | TORRENT PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090778 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090783 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090776 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-17 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090728 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090739 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | — | ZYDUS HEALTHCARE USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202949 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-09 | — | ALEMBIC PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202045 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203088 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | — | BRECKENRIDGE PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203197 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-26 | — | ALKEM LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090780 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202336 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | — | INVENTIA HEALTHCARE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204343 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-03 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208706 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-01-06 | — | AJANTA PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204815 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-23 | — | MACLEODS PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206653 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-05-18 | — | PRINSTON PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211310 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-16 | — | CSPC OUYI PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210599 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-17 | — | QINGDAO BAHEAL PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207219 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-16 | — | YAOPHARMA CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212328 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-02-11 | — | SUNSHINE LAKE PHARMA CO 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 22 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 |
|---|---|---|---|---|---|---|
| 090694 / 001 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090745 / 001 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090774 / 001 | TORRENT PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090778 / 001 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090783 / 001 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090776 / 001 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090728 / 001 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090739 / 001 | ZYDUS HEALTHCARE USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202949 / 001 | ALEMBIC PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202045 / 001 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203088 / 001 | BRECKENRIDGE PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203197 / 001 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090780 / 001 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202336 / 001 | INVENTIA HEALTHCARE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204343 / 001 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208706 / 001 | AJANTA PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-01-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204815 / 001 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206653 / 001 | PRINSTON PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-05-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211310 / 001 | CSPC OUYI PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210599 / 001 | QINGDAO BAHEAL PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207219 / 001 | YAOPHARMA CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212328 / 001 | SUNSHINE LAKE PHARMA CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-02-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (5)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PATENT | 2037-04-13 | FTO_TAIL | Claim 1: duloxetine sprinkle inert core/drug layer/enteric coat and 1-naphthol <=15% after six hours under acidic conditions. | Source |
| PATENT | 2037-04-13 | FTO_TAIL | Claims 1-4: sprinkle core/enteric coat with acid resistance, impurity, alcohol dissolution, and soft-food stability limitations. | Source |
| PATENT | 2037-04-13 | FTO_TAIL | Independent claims 1/14/16: inert core/drug layer, enteric coating 18-25%, polymer 75-99%, finishing layer, and 1-naphthol <=10% after six acidic hours, or fixed composition/strength. TRUE_DS N; DS-equivalent N. | Source |
| PATENT | 2037-04-13 | FTO_TAIL | Claim 1: duloxetine sprinkle inert core/drug layer/enteric coat, specific cushioning layer, and ethanol dissolution limitations. | Source |
| PATENT | 2037-04-13 | FTO_TAIL | Claims 1/5: drug core/enteric coat with impurity and alcohol-dissolution limitations. | 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.