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Last Updated: November 21, 2024

DAPTOMYCIN Drug Patent Profile


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Which patents cover Daptomycin, and when can generic versions of Daptomycin launch?

Daptomycin is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hisun Pharm Hangzhou, Hospira, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp. and is included in thirty NDAs. There are four patents protecting this drug.

This drug has thirty-six patent family members in twenty-three countries.

The generic ingredient in DAPTOMYCIN is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Daptomycin

A generic version of DAPTOMYCIN was approved as daptomycin by TEVA PHARMS USA on March 25th, 2016.

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Drug patent expirations by year for DAPTOMYCIN
Drug Prices for DAPTOMYCIN

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Recent Clinical Trials for DAPTOMYCIN

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

SponsorPhase
Chang Gung Memorial HospitalN/A
PfizerPhase 2
University Magna GraeciaPhase 4

See all DAPTOMYCIN clinical trials

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

DAPTOMYCIN is protected by four US patents.

Patents protecting DAPTOMYCIN

Daptomycin formulations and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND S. AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY RECONSTITUTING AND ADMINISTERING THE FORMULATION AS RECITED IN CLAIM 12


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Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOOD STREAM INFECTIONS

Daptomycin formulations and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY ADMINISTERING THE FORMULATION OF DAPTOMYCIN AS RECITED IN CLAIM 18

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 217415-001 Jan 30, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sagent Pharms Inc DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 207104-001 Nov 15, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xellia Pharms Aps DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 206005-001 Jun 15, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 091039-001 Mar 25, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 212667-001 Jul 12, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 210282-001 Jun 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

See the table below for patents covering DAPTOMYCIN around the world.

Country Patent Number Title Estimated Expiration
Germany 13837694 ⤷  Sign Up
Cyprus 2200004 ⤷  Sign Up
Mexico 2020001885 FORMULACIONES DE DAPTOMICINA. (DAPTOMYCIN FORMULATIONS.) ⤷  Sign Up
Canada 2884484 FORMULATIONS DE DAPTOMYCINE ET LEURS UTILISATIONS (DAPTOMYCIN FORMULATIONS AND USES THEREOF) ⤷  Sign Up
Chile 2015000608 Formulaciones de daptomicina y usos de la misma ⤷  Sign Up
Brazil 112020003862 formulações de daptomicina. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAPTOMYCIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1115417 06C0022 France ⤷  Sign Up PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 SPC/GB06/024 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: DAPTOMYCIN
1115417 CA 2006 00018 Denmark ⤷  Sign Up PRODUCT NAME: DAPTOMYCIN
1115417 22/2006 Austria ⤷  Sign Up 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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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.