Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Baxter
Merck
Harvard Business School
Colorcon
Johnson and Johnson
McKesson

Last Updated: May 19, 2022

Daptomycin - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

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

Daptomycin is the generic ingredient in four branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hangzhou Zhongmei, Hisun Pharm Hangzhou, Hospira Inc, Jiangsu Pharms, Meitheal, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in twenty-four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Daptomycin has seventy-two patent family members in thirty-seven countries.

There are ten drug master file entries for daptomycin. Twenty-three 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
Sunnybrook Health Sciences CentrePhase 4
University of MelbournePhase 4
Berry ConsultantsPhase 4

See all daptomycin clinical trials

Generic filers with tentative approvals for DAPTOMYCIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing350MG/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 Strength NDA ANDAs Submitted Submissiondate
CUBICIN RF For Injection daptomycin 500 mg/vial 021572 1 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
Hospira Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 210282-002 Jun 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 210282-001 Jun 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Baxter Hlthcare Corp DAPZURA RT daptomycin POWDER;INTRAVENOUS 213645-001 Jan 25, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sagent Pharms Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 207104-001 Nov 15, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sagent Pharms Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 208385-001 Sep 12, 2017 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 211961-001 Jun 24, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for daptomycin

Country Patent Number Title Estimated Expiration
Ecuador SP12011939 Compuestos Lipopéptidos y métodos relacionados See Plans and Pricing
Taiwan 201141506 Daptomycin compositions and related methods See Plans and Pricing
Morocco 37956 Formulations de daptomycine et leurs utilisations See Plans and Pricing
Israel 219891 תכשירים של ליפופפטיד (Lipopeptide compositions) See Plans and Pricing
Hungary E13837694 See Plans and Pricing
Chile 2015002412 Composición farmacéutica sólida de daptomicina; método de fabricación; y uso para tratar infecciones bacterianas (divisional de la sol. 1336-2012) See Plans and Pricing
Canada 2610716 DAPTOMYCINE POUR LE TRAITEMENT D'UN BIOFILM ET LA RECUPERATION D'UN CATHETER (DAPTOMYCIN FOR THE TREATMENT OF BIOFILM AND CATHETER SALVAGE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for daptomycin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1115417 SPC/GB06/024 United Kingdom See Plans and Pricing 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 22/2006 Austria See Plans and Pricing PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417 06C0022 France See Plans and Pricing PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 SZ 22/2006 Austria See Plans and Pricing PRODUCT NAME: DAPTOMYCIN
1115417 CA 2006 00018 Denmark See Plans and Pricing PRODUCT NAME: DAPTOMYCIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Moodys
McKinsey
Colorcon
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.