Product profile · United States

HEPARIN SODIUM

· Patent Litigation & Settlement History ↓

IngredientHEPARIN SODIUM

Application typeNDA

Application201370

Product003

Dosage formINJECTABLE

RouteINJECTION

Strength10,000 UNITS/ML

Approval date2011-07-21

Marketing statusDiscontinued

Status event—

ApplicantPFIZER

Product source

Current GenericRadar decision

Year—

SelectionDISCONTINUED

ReviewFINAL

Anchor typeDISCONTINUATION

Anchor date—

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA—

Status event—

Discontinued in the 2026-10-10 product snapshot. The actual discontinuation date is unverified; retain NULL date and year.

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
087107 / 001	FINAL_APPROVAL_DATE_UNCONFIRMED · FINAL_APPROVAL_DATE_UNCONFIRMED	—	—	SOLOPAK MEDICAL PRODUCTS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
089522 / 001	FINAL_APPROVAL · FINAL_APPROVED	1987-05-04	—	HOSPIRA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
040095 / 001	FINAL_APPROVAL · FINAL_APPROVED	1996-07-26	—	HOSPIRA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
090571 / 003	FINAL_APPROVAL · FINAL_APPROVED	2009-08-31	—	HOSPIRA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
090808 / 003	FINAL_APPROVAL · FINAL_APPROVED	2010-06-30	—	SAGENT PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
201002 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-06-08	—	PLANO PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
203198 / 001	FINAL_APPROVAL · FINAL_APPROVED	2014-06-12	—	SHENZHEN TECHDOW PHARMACEUTICAL CO LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
203851 / 003	FINAL_APPROVAL · FINAL_APPROVED	2017-11-30	—	PHARMOBEDIENT CONSULTING LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211007 / 003	FINAL_APPROVAL · FINAL_APPROVED	2019-05-28	—	EMERGE BIOSCIENCE PTE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
212060 / 001	FINAL_APPROVAL · FINAL_APPROVED	2020-04-02	—	EMERGE BIOSCIENCE PTE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214839 / 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 10 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
089522 / 001	HOSPIRA INC	FINAL_APPROVAL · FINAL_APPROVED	1987-05-04	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
040095 / 001	HOSPIRA INC	FINAL_APPROVAL · FINAL_APPROVED	1996-07-26	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
090571 / 003	HOSPIRA INC	FINAL_APPROVAL · FINAL_APPROVED	2009-08-31	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
090808 / 003	SAGENT PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2010-06-30	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
201002 / 001	PLANO PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2011-06-08	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
203198 / 001	SHENZHEN TECHDOW PHARMACEUTICAL CO LTD	FINAL_APPROVAL · FINAL_APPROVED	2014-06-12	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
203851 / 003	PHARMOBEDIENT CONSULTING LLC	FINAL_APPROVAL · FINAL_APPROVED	2017-11-30	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211007 / 003	EMERGE BIOSCIENCE PTE LTD	FINAL_APPROVAL · FINAL_APPROVED	2019-05-28	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
212060 / 001	EMERGE BIOSCIENCE PTE LTD	FINAL_APPROVAL · FINAL_APPROVED	2020-04-02	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214839 / 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.