Product profile · United States
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· Patent Litigation & Settlement History ↓
Current GenericRadar decision
Current official Orange Book exact product Type=OTC. Excluded under guideline section 4 OTC-only rule. Historical prescription status and switch effective date are not asserted.
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 · 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 |
|---|---|---|---|---|---|---|---|
| 207193 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-08-18 | — | PERRIGO R AND D CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209339 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-16 | — | AUROBINDO PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207673 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-05-15 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 209716 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-05 | — | AMNEAL PHARMACEUTICALS OF NY LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212376 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-16 | — | PHARMOBEDIENT CONSULTING LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212866 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-04 | — | SUN PHARMACEUTICAL INDUSTRIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 208939 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-28 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212507 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-06-02 | — | HETERO LABS LTD UNIT III | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216349 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2022-06-24 | — | GRAVITI PHARMACEUTICALS PRIVATE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 216149 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-03-15 | — | GUARDIAN DRUG CO | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 217264 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2023-09-29 | — | MARKSANS PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 207198 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-30 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 218092 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2024-06-11 | — | GLENMARK SPECIALTY SA | 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 13 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 |
|---|---|---|---|---|---|---|
| 207193 / 001 | PERRIGO R AND D CO | FINAL_APPROVAL · FINAL_APPROVED | 2017-08-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209339 / 001 | AUROBINDO PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2017-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207673 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-05-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 209716 / 001 | AMNEAL PHARMACEUTICALS OF NY LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-06-05 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212376 / 001 | PHARMOBEDIENT CONSULTING LLC | FINAL_APPROVAL · FINAL_APPROVED | 2019-10-16 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212866 / 001 | SUN PHARMACEUTICAL INDUSTRIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-04 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 208939 / 001 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2020-05-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 212507 / 001 | HETERO LABS LTD UNIT III | FINAL_APPROVAL · FINAL_APPROVED | 2020-06-02 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216349 / 001 | GRAVITI PHARMACEUTICALS PRIVATE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2022-06-24 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 216149 / 001 | GUARDIAN DRUG CO | FINAL_APPROVAL · FINAL_APPROVED | 2023-03-15 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 217264 / 001 | MARKSANS PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2023-09-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 207198 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 2024-04-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 218092 / 001 | GLENMARK SPECIALTY SA | FINAL_APPROVAL · FINAL_APPROVED | 2024-06-11 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
Decision evidence (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| PRODUCT_STATUS | — | EXCLUSION_BASIS | Exact application/product matched to current Orange Book Type=OTC; no patent or generic conclusion inferred. | 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.