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Last Updated: November 28, 2020

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Daptomycin - Generic Drug Details

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

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

Daptomycin has forty-eight patent family members in thirty-one countries.

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

Drug Prices for daptomycin

See drug prices for daptomycin

Recent Clinical Trials for daptomycin

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

SponsorPhase
University Hospital, CaenPhase 1
Vancouver Island Health AuthorityPhase 4
Instituto de Salud Carlos IIIPhase 4

See all daptomycin clinical trials

Generic filers with tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial350MG/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 POWDER;INTRAVENOUS daptomycin 021572 2008-11-19
CUBICIN RF 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
Teva Pharms Usa DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 091039-001 Mar 25, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Be Pharms DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 213425-001 Aug 20, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 DISCN No No   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003   Start Trial   Start Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003   Start Trial   Start Trial
>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 CA 2006 00018 Denmark   Start Trial PRODUCT NAME: DAPTOMYCIN
1115417 SPC/GB06/024 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
1115417 SZ 22/2006 Austria   Start Trial PRODUCT NAME: DAPTOMYCIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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