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Generated: July 27, 2017
What are the generic drug sources for daptomycin and what is the scope of daptomycin freedom to operate?
Daptomycin is the generic ingredient in three branded drugs marketed by Crane Pharms Llc, Teva Parenteral, Hospira Inc, and Cubist Pharms Llc, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 9 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 49 |
| Clinical Trials: see list | 73 |
| Patent Applications: see list | 3,312 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | daptomycin at DailyMed |
| Ingredient-type | Lipopeptides |
| Drug Class | Lipopeptide Antibacterial |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 350MG/VIAL | POWDER;INTRAVENOUS |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;IV (INFUSION) | 021572-001 | Sep 12, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Teva Parenteral | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 091039-001 | Mar 25, 2016 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;IV (INFUSION) | 021572-001 | Sep 12, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;IV (INFUSION) | 021572-001 | Sep 12, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,835,382 | Lipopeptide compositions and related methods | ► Subscribe | |||||||||||||||||||||||||||
| 9,662,397 | Lipopeptide compositions and related methods | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dominican Republic | P2012000140 | ► Subscribe | |||||||||||||||||||||||||||
| Ecuador | SP12011939 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 201141506 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2016147874 | ► Subscribe | |||||||||||||||||||||||||||
| Peru | 17172015 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB06/024 | United Kingdom | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119 | ||||||||||||||||||||||||||
| C0022 | France | ► Subscribe | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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