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Daptomycin - Generic Drug Details
What are the generic drug sources for daptomycin and what is the scope of daptomycin patent protection?
Daptomycin
is the generic ingredient in three branded drugs marketed by Cubist Pharms Llc, Crane Pharms Llc, Fresenius Kabi Usa, Hospira Inc, Mylan Labs Ltd, Teva Pharms Usa, Sagent Pharms, and Xellia Pharms Aps, and is included in eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for daptomycin. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for daptomycin
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 8 |
| NDAs: | 8 |
| Drug Master File Entries: | 10 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 76 |
| Patent Applications: | 4,113 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for daptomycin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for daptomycin |
| DailyMed Link: | daptomycin at DailyMed |
Pharmacology for daptomycin
| Ingredient-type | Lipopeptides |
| Drug Class | Lipopeptide Antibacterial |
Medical Subject Heading (MeSH) Categories for daptomycin
Synonyms for daptomycin
| 060D533 |
| 103060-53-3 |
| 2,2'-((3S,6S,9R,15S,18R,21S,24S)-30-((S)-2-((S)-4-amino-2-((S)-2-decanamido-3-(1H-indol-3-yl)propanamido)-4-oxobutanamido)-3-carboxypropanamido)-3-(2-(2-aminophenyl)-2-oxoethyl)-24-(3-amino |
| AB0012614 |
| AB01274779_02 |
| AB01274779-01 |
| AC-1162 |
| ACN-036875 |
| AKOS005146218 |
| AKOS024457871 |
| AKOS025401343 |
| AKOS026750170 |
| AKOS032949840 |
| AM000687 |
| AM011338 |
| AN-5525 |
| Antibiotic A-21978 C0 |
| AOB87734 |
| AS-12931 |
| BC677644 |
| C12013 |
| C72H101N17O26 |
| CHEBI:600103 |
| CHEMBL1649722 |
| CHEMBL387675 |
| CHEMBL404822 |
| Cidecin |
| CS-1857 |
| Cubicin |
| Cubicin (TN) |
| Cubicin Rf |
| D01080 |
| D05HPI |
| D4229 |
| Dapcin |
| Daptomicina |
| Daptomicina [Spanish] |
| Daptomycin (JAN/USAN/INN) |
| Daptomycin [USAN:INN:BAN] |
| Daptomycin for injection |
| Daptomycin Ready Made Solution |
| Daptomycin, cyclic lipopeptide antibiotic |
| Daptomycine |
| Daptomycine [French] |
| Daptomycinum |
| Daptomycinum [Latin] |
| DB00080 |
| Deptomycin |
| DOAKLVKFURWEDJ-RWDRXURGSA-N |
| HY-B0108 |
| LS-171846 |
| LY 146032 |
| LY-146032 |
| LY146032 |
| MFCD08282794 |
| MK-3009 |
| MolPort-003-846-138 |
| MolPort-023-276-990 |
| MolPort-046-033-485 |
| N-(1-Oxodecyl)-L-tryptophyl-D-asparaginyl-L-?-aspartyl-L-threonylglycyl-L-ornithinyl-L-?-aspartyl-D-alanyl-L-?-aspartylglycyl-D-seryl-(3R)-3-methyl-L-?-glutamyl-?,2-diamino-?-oxo-benzene butanoic acid (13-4) lactone |
| N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine 1.13-3.4-lactone |
| N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon(1)-lactone |
| N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine 1.13-3.4-lactone |
| N-decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon(1)-lactone |
| N-Decanoyl-L-tryptophyl-L-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine epsilon1-lactone |
| N-decanoyl-L-tryptophyl-L-asparaginyl-N-[(3S,6S,9R,15S,18R,21S,24S,30S,31R)-3-[2-(2-aminophenyl)-2-oxoethyl]-24-(3-aminopropyl)-15,21-bis(carboxymethyl)-6-[(2R)-1-carboxypropan-2-yl]-9-(hydroxymethyl)-18,31-dimethyl-2,5,8,11, |
| NCGC00346517-01 |
| NWQ5N31VKK |
| propyl)-6-(1-carboxypropan-2-yl)-9-(hydroxymethyl)-18,31-dimethyl-2,5,8,11,14,17,20,23,26,29-decaoxo-1-oxa-4,7,10,13,16,19,22,25,28-nonaazacyclohentriacontane-15,21-diyl)diacetic acid |
| Q-200927 |
| S-7668 |
| s1373 |
| SCHEMBL13491700 |
| SCHEMBL1650768 |
| SCHEMBL28102 |
| SCHEMBL8221756 |
| SCHEMBL8221760 |
| UNII-NWQ5N31VKK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Crane Pharms Llc | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 206005-001 | Jun 15, 2016 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | AP | RX | Yes | Yes | ➤ 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 | |||
| Fresenius Kabi Usa | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 206077-001 | Apr 11, 2018 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sagent Pharms | DAPTOMYCIN | daptomycin | POWDER;IV (INFUSION) | 208385-001 | Sep 12, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;IV (INFUSION) | 021572-001 | Sep 12, 2003 | ➤ Sign Up | ➤ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;IV (INFUSION) | 021572-001 | Sep 12, 2003 | ➤ Sign Up | ➤ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for daptomycin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201141506 | ➤ Sign Up |
| Japan | 2017075186 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006130629 | ➤ Sign Up |
| Taiwan | 201703791 | ➤ Sign Up |
| Russian Federation | 2012126076 | ➤ Sign Up |
| Israel | 219891 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for daptomycin
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/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. |
| /2006 | Austria | ➤ Sign Up | PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119 |
| 22/2006 | Austria | ➤ Sign Up | PRODUCT NAME: DAPTOMYCIN |
| C0022 | France | ➤ Sign Up | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 |
| 2006 00018 | Denmark | ➤ Sign Up | PRODUCT NAME: DAPTOMYCIN |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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