Daptomycin - Generic Drug Details
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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.
Summary for daptomycin
International Patents: | 72 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 17 |
NDAs: | 24 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 89 |
Patent Applications: | 7,186 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Sunnybrook Health Sciences Centre | Phase 4 |
University of Melbourne | Phase 4 |
Berry Consultants | Phase 4 |
Generic filers with tentative approvals for DAPTOMYCIN
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 350MG/VIAL | POWDER;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
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
Expired US Patents for daptomycin
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 |
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