Product profile · United States
CYMBALTA
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
FDA Final ANDA 090723 explicitly identifies Cymbalta Lilly 20/30/60 mg RLDs. Earliest date is based on candidate source documents and FDA electronic signatures. Evidence limits: see source report.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| No patent facts are recorded for this product. | ||||||||
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 / 004 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | LUPIN LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090723 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | ADAPTIS PHARMA PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 090723 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | ADAPTIS PHARMA PRIVATE LTD | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 090745 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090774 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | TORRENT PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090778 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090783 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | — | TEVA PHARMACEUTICALS USA | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090723 / 003 | FINAL_APPROVAL · FINAL_APPROVAL | 2013-12-11 | — | Dr. Reddy's Laboratories Limited | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 090723 / 003 | FINAL_APPROVAL · FINAL_APPROVAL | 2013-12-11 | — | Dr. Reddy's Laboratories Limited | N | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source |
| 090776 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-17 | — | ACTAVIS ELIZABETH LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090728 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | — | ZYDUS PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090739 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | — | ZYDUS HEALTHCARE USA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202949 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-09 | — | ALEMBIC PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202045 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | — | APOTEX INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203088 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | — | BRECKENRIDGE PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203197 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-26 | — | ALKEM LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090780 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | — | PH HEALTH LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202336 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | — | INVENTIA HEALTHCARE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204343 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-03 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208706 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2017-01-06 | — | AJANTA PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 204815 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-23 | — | MACLEODS PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 206653 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2017-05-18 | — | PRINSTON PHARMACEUTICAL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211310 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-16 | — | CSPC OUYI PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210599 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-17 | — | QINGDAO BAHEAL PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207219 / 003 | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-16 | — | YAOPHARMA CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212328 / 003 | 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 26 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 / 004 | LUPIN LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090723 / 003 | ADAPTIS PHARMA PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 090723 / 003 | ADAPTIS PHARMA PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 090745 / 003 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090774 / 003 | TORRENT PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090778 / 003 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090783 / 003 | TEVA PHARMACEUTICALS USA | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090723 / 003 | Dr. Reddy's Laboratories Limited | FINAL_APPROVAL · FINAL_APPROVAL | 2013-12-11 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 090723 / 003 | Dr. Reddy's Laboratories Limited | FINAL_APPROVAL · FINAL_APPROVAL | 2013-12-11 | EXACT_PRODUCT · EXACT_PRODUCT_VERIFIED | Source | — |
| 090776 / 003 | ACTAVIS ELIZABETH LLC | FINAL_APPROVAL · FINAL_APPROVED | 2013-12-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090728 / 003 | ZYDUS PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090739 / 003 | ZYDUS HEALTHCARE USA LLC | FINAL_APPROVAL · FINAL_APPROVED | 2014-01-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202949 / 003 | ALEMBIC PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202045 / 003 | APOTEX INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203088 / 003 | BRECKENRIDGE PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203197 / 003 | ALKEM LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-08-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090780 / 003 | PH HEALTH LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202336 / 003 | INVENTIA HEALTHCARE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2015-10-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204343 / 003 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2016-08-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208706 / 003 | AJANTA PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-01-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 204815 / 003 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-03-23 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 206653 / 003 | PRINSTON PHARMACEUTICAL INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-05-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211310 / 003 | CSPC OUYI PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210599 / 003 | QINGDAO BAHEAL PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-04-17 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207219 / 003 | YAOPHARMA CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-08-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212328 / 003 | SUNSHINE LAKE PHARMA CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2021-02-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| GENERIC_APPROVAL | 2013-12-11 | DISQUALIFYING_FINAL_GENERIC | FDA Final exact RLD/strength match; tentative not used. | 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.