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Serving leading biopharmaceutical companies globally:

Moodys
Farmers Insurance
Harvard Business School
Colorcon
Citi
Dow
Medtronic
Deloitte
Covington
Baxter

Generated: February 18, 2018

DrugPatentWatch Database Preview

Daptomycin - Generic Drug Details

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

Daptomycin
is the generic ingredient in three branded drugs marketed by Cubist Pharms Llc, Crane Pharms Llc, Hospira Inc, Teva Parenteral, Sagent Pharms, and Xellia Pharms Aps, and is included in six 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 thirty-two patent family members in nineteen countries.

There are nine drug master file entries for daptomycin. Five suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for daptomycin
Ingredient-typeLipopeptides
Drug ClassLipopeptide Antibacterial
Medical Subject Heading (MeSH) Categories for daptomycin
Tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial350MG/VIALPOWDER;INTRAVENOUS

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
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 202857-001 Sep 12, 2014 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sagent Pharms DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 208385-001 Sep 12, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Crane Pharms Llc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 206005-001 Jun 15, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;IV (INFUSION) 209949-001 Oct 20, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc CUBICIN daptomycin POWDER;IV (INFUSION) 021572-001 Sep 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for daptomycin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,835,382 Lipopeptide compositions and related methods ➤ Try a Free Trial
9,662,397 Lipopeptide compositions and related methods ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for daptomycin

Supplementary Protection Certificates for daptomycin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 00018 Denmark ➤ Try a Free Trial PRODUCT NAME: DAPTOMYCIN
/2006 Austria ➤ Try a Free Trial PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
C0022 France ➤ Try a Free Trial PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
C/GB06/024 United Kingdom ➤ Try a Free 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.
22/2006 Austria ➤ Try a Free Trial PRODUCT NAME: DAPTOMYCIN
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Julphar
Mallinckrodt
Accenture
McKinsey
Farmers Insurance
Merck
Fish and Richardson
Citi

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