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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Summary for DAPTOMYCIN
International Patents: | 36 |
US Patents: | 4 |
Applicants: | 20 |
NDAs: | 30 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 92 |
Patent Applications: | 3,990 |
Drug Prices: | Drug price information for DAPTOMYCIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DAPTOMYCIN |
What excipients (inactive ingredients) are in DAPTOMYCIN? | DAPTOMYCIN excipients list |
DailyMed Link: | DAPTOMYCIN at DailyMed |
Recent Clinical Trials for DAPTOMYCIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chang Gung Memorial Hospital | N/A |
Pfizer | Phase 2 |
University Magna Graecia | Phase 4 |
Pharmacology for DAPTOMYCIN
Drug Class | Lipopeptide Antibacterial |
Medical Subject Heading (MeSH) Categories for DAPTOMYCIN
Anatomical Therapeutic Chemical (ATC) Classes 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
Patent Number: ⤷ Sign Up
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 |