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Last Updated: October 26, 2021

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Enoxaparin sodium - Generic Drug Details

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What are the generic sources for enoxaparin sodium and what is the scope of patent protection?

Enoxaparin sodium is the generic ingredient in four branded drugs marketed by Amphastar Pharms Inc, Sandoz Inc, Sanofi Aventis Us, Amphastar Pharm, Apotex Inc, Nanjing King-friend, Sandoz, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for enoxaparin sodium. Thirteen suppliers are listed for this compound.

Drug Prices for enoxaparin sodium

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Recent Clinical Trials for enoxaparin sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Istanbul UniversityPhase 2/Phase 3
Weill Medical College of Cornell UniversityPhase 4
Xijing HospitalPhase 2/Phase 3

See all enoxaparin sodium clinical trials

Pharmacology for enoxaparin sodium
Medical Subject Heading (MeSH) Categories for enoxaparin sodium
Paragraph IV (Patent) Challenges for ENOXAPARIN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
LOVENOX (PRESERVATIVE FREE) INJECTABLE;SUBCUTANEOUS enoxaparin sodium 020164 2006-12-07
LOVENOX INJECTABLE;INTRAVENOUS, SUBCUTANEOUS enoxaparin sodium 020164 2006-12-07

US Patents and Regulatory Information for enoxaparin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857-007 Jul 23, 2010 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Nanjing King-friend ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 206834-003 Nov 29, 2019 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076726-006 Jun 23, 2014 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857-005 Jul 23, 2010 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for enoxaparin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-006 Jun 2, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-008 Jun 2, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-007 Jun 2, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-004 Mar 27, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Medtronic
Johnson and Johnson
Dow
Mallinckrodt

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