Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Colorcon
Medtronic
Harvard Business School
Merck

Last Updated: December 5, 2022

Daptomycin - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

Daptomycin is the generic ingredient in four branded drugs marketed by Aspiro, Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hisun Pharm Hangzhou, Hospira, 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-six 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-six patent family members in thirty-seven countries.

There are ten drug master file entries for daptomycin. Twenty-five 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 Magna GraeciaPhase 4
The University of QueenslandPhase 4
Tan Tock Seng HospitalPhase 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
Dr Reddys DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 208375-001 May 1, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Meitheal DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213623-001 Jun 29, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213171-001 Sep 2, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 209949-001 Oct 20, 2017 RX Yes Yes 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 021572-001 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

EU/EMA Drug Approvals for daptomycin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Daptomycin Hospira daptomycin EMEA/H/C/004310
Daptomycin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised yes no no 2017-03-22
Merck Sharp & Dohme B.V. Cubicin daptomycin EMEA/H/C/000637
Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2006-01-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for daptomycin

Country Patent Number Title Estimated Expiration
Dominican Republic P2012000140 COMPUESTOS LIPOPEPTIDOS Y METODOS RELACIONADOS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006130629 See Plans and Pricing
Brazil 112012012406 composições de lipopepitídeos e métodos relacionados See Plans and Pricing
Turkey 201812823 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 SZ 22/2006 Austria See Plans and Pricing PRODUCT NAME: DAPTOMYCIN
1115417 06C0022 France See Plans and Pricing PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 22/2006 Austria See Plans and Pricing PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
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.
>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:

McKinsey
Colorcon
Dow
Medtronic
Boehringer Ingelheim
McKesson

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.