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Last Updated: September 25, 2021

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DAPTOMYCIN - Generic Drug Details

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What are the generic drug sources for daptomycin and what is the scope of freedom to operate?

Daptomycin is the generic ingredient in three branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Fresenius Kabi Usa, Hisun Pharm Hangzhou, Hong Kong, Hospira Inc, Jiangsu Hengrui Med, Mylan Labs Ltd, Sagent Pharms Inc, Teva Pharms Usa, and Xellia Pharms Aps, and is included in twenty NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Daptomycin has seventy patent family members in thirty-six countries.

There are ten drug master file entries for daptomycin. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for DAPTOMYCIN

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Recent Clinical Trials for DAPTOMYCIN

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
University Hospital, CaenPhase 1
Vancouver Island Health AuthorityPhase 4

See all DAPTOMYCIN clinical trials

Generic filers with tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free350MG/VIALPOWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DAPTOMYCIN
Medical Subject Heading (MeSH) Categories for DAPTOMYCIN
Paragraph IV (Patent) Challenges for DAPTOMYCIN
Tradename Dosage Ingredient NDA Submissiondate
CUBICIN RF POWDER;INTRAVENOUS daptomycin 021572 2008-11-19
CUBICIN POWDER;INTRAVENOUS daptomycin 021572 2008-11-19

US Patents and Regulatory Information for DAPTOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Pharms Inc DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 208385-001 Sep 12, 2017 AP RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 209949-001 Oct 20, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hong Kong DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213623-001 Jun 29, 2021 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 DAPTOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DAPTOMYCIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1115417 SZ 22/2006 Austria ⤷  Try it Free PRODUCT NAME: DAPTOMYCIN
1115417 06C0022 France ⤷  Try it Free PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 22/2006 Austria ⤷  Try it Free PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
McKesson
Johnson and Johnson
Colorcon
Dow

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