Product profile · United States
HEPARIN SODIUM PRESERVATIVE FREE
· 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 086129 / 001 | FINAL_APPROVAL_DATE_UNCONFIRMED · FINAL_APPROVAL_DATE_UNCONFIRMED | — | — | PHARMA SERVE INC SUB TORIGIAN LABORATORIES | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 087043 / 001 | FINAL_APPROVAL_DATE_UNCONFIRMED · FINAL_APPROVAL_DATE_UNCONFIRMED | — | — | SOLOPAK MEDICAL PRODUCTS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 087452 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1983-10-31 | — | LUITPOLD PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 088239 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1984-07-26 | — | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 089464 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1986-06-03 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 040008 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1995-10-10 | — | WATSON LABORATORIES INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 040007 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 1996-06-07 | — | DR REDDYS LABORATORIES LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090571 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-31 | — | HOSPIRA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090808 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2010-06-30 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 090810 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2010-06-30 | — | SAGENT PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 091682 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2011-06-08 | — | PLANO PHARMACEUTICALS INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202732 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-12 | — | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 202957 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-12 | — | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 203851 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-30 | — | PHARMOBEDIENT CONSULTING LLC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211005 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-14 | — | EMERGE BIOSCIENCE PTE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 211007 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-28 | — | EMERGE BIOSCIENCE PTE LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 205323 / 002 | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-18 | — | GLAND PHARMA LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 214804 / 001 | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-29 | — | BE PHARMACEUTICALS AG | 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 16 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 |
|---|---|---|---|---|---|---|
| 087452 / 001 | LUITPOLD PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 1983-10-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 088239 / 001 | SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW | FINAL_APPROVAL · FINAL_APPROVED | 1984-07-26 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 089464 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 1986-06-03 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 040008 / 001 | WATSON LABORATORIES INC | FINAL_APPROVAL · FINAL_APPROVED | 1995-10-10 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 040007 / 001 | DR REDDYS LABORATORIES LTD | FINAL_APPROVAL · FINAL_APPROVED | 1996-06-07 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090571 / 001 | HOSPIRA INC | FINAL_APPROVAL · FINAL_APPROVED | 2009-08-31 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090808 / 001 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2010-06-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 090810 / 001 | SAGENT PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2010-06-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 091682 / 001 | PLANO PHARMACEUTICALS INC | FINAL_APPROVAL · FINAL_APPROVED | 2011-06-08 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202732 / 001 | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 202957 / 001 | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | FINAL_APPROVAL · FINAL_APPROVED | 2014-06-12 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 203851 / 001 | PHARMOBEDIENT CONSULTING LLC | FINAL_APPROVAL · FINAL_APPROVED | 2017-11-30 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211005 / 001 | EMERGE BIOSCIENCE PTE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2018-12-14 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 211007 / 001 | EMERGE BIOSCIENCE PTE LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-05-28 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 205323 / 002 | GLAND PHARMA LTD | FINAL_APPROVAL · FINAL_APPROVED | 2019-11-18 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source | — |
| 214804 / 001 | BE PHARMACEUTICALS AG | FINAL_APPROVAL · FINAL_APPROVED | 2020-12-29 | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | 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.