Product profile · United States
LYMEPAK
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted.
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. | ||||||||
2026-10-11 · 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 |
|---|---|---|---|---|---|---|---|
| 062391 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1982-09-30 | — | MUTUAL PHARMACEUTICAL CO INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062269 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1982-11-08 | — | EPIC PHARMA LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062421 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1983-02-02 | — | ACTAVIS LABORATORIES FL INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062432 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1983-02-15 | — | MYLAN PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062392 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 1983-03-31 | — | WATSON LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062462 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1983-05-11 | — | HEATHER DRUG CO INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062505 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1984-09-11 | — | CHARTWELL SCHEDULED LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062494 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1985-02-20 | — | SUPERPHARM CORP | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062581 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1985-03-15 | — | TEVA PHARMACEUTICALS USA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062593 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1985-08-28 | — | WARNER CHILCOTT DIV WARNER LAMBERT CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062538 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1986-04-07 | — | STRIDES PHARMA INTERNATIONAL AG | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062677 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1986-07-10 | — | SUN PHARMACEUTICAL INDUSTRIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 062764 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1988-09-02 | — | INTERPHARM INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 065095 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2003-07-02 | — | HIKMA INTERNATIONAL PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207558 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-06 | — | NOVEL LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207773 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-30 | — | ZYDUS LIFESCIENCES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209969 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-09 | — | AVET LIFESCIENCES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211343 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-09 | — | CHANGZHOU PHARMACEUTICAL FACTORY | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210664 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-03-16 | — | ACELLA PHARMACEUTICALS LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 210536 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-14 | — | ALEMBIC PHARMACEUTICALS LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 213475 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-10 | — | ORYZA PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212487 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-03-30 | — | ARTHUR GROUP LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216599 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-24 | — | AMNEAL EU LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209560 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-15 | — | PHARMOBEDIENT CONSULTING LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211418 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-19 | — | MACLEODS PHARMACEUTICALS 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 25 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 |
|---|---|---|---|---|---|---|
| 062391 / 001 | MUTUAL PHARMACEUTICAL CO INC | FINAL_APPROVAL · FINAL_APPROVED | 1982-09-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062269 / 002 | EPIC PHARMA LLC | FINAL_APPROVAL · FINAL_APPROVED | 1982-11-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062421 / 001 | ACTAVIS LABORATORIES FL INC | FINAL_APPROVAL · FINAL_APPROVED | 1983-02-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062432 / 001 | MYLAN PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 1983-02-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062392 / 002 | WATSON LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 1983-03-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062462 / 001 | HEATHER DRUG CO INC | FINAL_APPROVAL · FINAL_APPROVED | 1983-05-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062505 / 001 | CHARTWELL SCHEDULED LLC | FINAL_APPROVAL · FINAL_APPROVED | 1984-09-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062494 / 001 | SUPERPHARM CORP | FINAL_APPROVAL · FINAL_APPROVED | 1985-02-20 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062581 / 001 | TEVA PHARMACEUTICALS USA INC | FINAL_APPROVAL · FINAL_APPROVED | 1985-03-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062593 / 001 | WARNER CHILCOTT DIV WARNER LAMBERT CO | FINAL_APPROVAL · FINAL_APPROVED | 1985-08-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062538 / 001 | STRIDES PHARMA INTERNATIONAL AG | FINAL_APPROVAL · FINAL_APPROVED | 1986-04-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062677 / 001 | SUN PHARMACEUTICAL INDUSTRIES INC | FINAL_APPROVAL · FINAL_APPROVED | 1986-07-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 062764 / 001 | INTERPHARM INC | FINAL_APPROVAL · FINAL_APPROVED | 1988-09-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 065095 / 001 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2003-07-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207558 / 001 | NOVEL LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 2017-09-06 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207773 / 001 | ZYDUS LIFESCIENCES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209969 / 001 | AVET LIFESCIENCES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-11-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211343 / 001 | CHANGZHOU PHARMACEUTICAL FACTORY | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-09 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210664 / 001 | ACELLA PHARMACEUTICALS LLC | FINAL_APPROVAL · FINAL_APPROVED | 2020-03-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 210536 / 001 | ALEMBIC PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 213475 / 001 | ORYZA PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2021-03-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212487 / 001 | ARTHUR GROUP LLC | FINAL_APPROVAL · FINAL_APPROVED | 2022-03-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216599 / 001 | AMNEAL EU LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-10-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209560 / 001 | PHARMOBEDIENT CONSULTING LLC | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211418 / 001 | MACLEODS PHARMACEUTICALS LTD | FINAL_APPROVAL · FINAL_APPROVED | 2025-11-19 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| REGULATORY_STATUS | — | TERMINAL_STATUS | Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. Current FDA Orange Book lists the exact product as discontinued. The actual discontinuation date is not established and is kept null; approval and observation dates are not substituted. | 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.