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Generated: July 24, 2017
What is the competitive landscape for CUBIST PHARMS, and what generic alternatives to CUBIST PHARMS drugs are available?
CUBIST PHARMS has six approved drugs.| Patents: | 20 |
| Tradenames: | 6 |
| Ingredients: | 5 |
| NDAs: | 6 |
| 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 | SIVEXTRO | tedizolid phosphate | POWDER;IV (INFUSION) | 205436-001 | Jun 20, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Cubist Pharms Llc | ZERBAXA | ceftolozane sulfate; tazobactam sodium | POWDER;IV (INFUSION) | 206829-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► 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;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | ► 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 | ||||||||||||||||||||||
Cubist Pharms | ENTEREG | alvimopan | CAPSULE;ORAL | 021775-001 | May 20, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
fidaxomicin | Tablets | 200 mg | DIFICID | 5/27/2015 |
daptomycin | For Injection | 500 mg/vial | CUBICIN | 11/19/2008 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,662,397 | Lipopeptide compositions and related methods | ► Subscribe | |||||||||||||||||||||||||||
| 9,163,043 | Oxazolidinone derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 7,696,220 | Methods for the treatment or inhibition of ileus | ► Subscribe | |||||||||||||||||||||||||||
| 8,835,382 | Lipopeptide compositions and related methods | ► Subscribe | |||||||||||||||||||||||||||
| 8,518,899 | Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 1765312 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I425942 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2391820 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 516024 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5468388 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 50021-2015 | Slovakia | ► Subscribe | PRODUCT NAME: TEDIZOLIDFOSFAT; REGISTRATION NO/DATE: EU/1/15/991/001 - EU/1/15/991/003 20150325 | ||||||||||||||||||||||||||
| /2006 | Austria | ► Subscribe | PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119 | ||||||||||||||||||||||||||
| 2015 00048 | Denmark | ► Subscribe | PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TEDIZOLID PHOSPHATE; REG. NO/DATE: EU/1/15/991 20150325 | ||||||||||||||||||||||||||
| 00759 | Netherlands | ► Subscribe | PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323 | ||||||||||||||||||||||||||
| 0793 | Netherlands | ► Subscribe | PRODUCT NAME: CEFTOLOZAAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN IN HET BIJZONDER EEN ZWAVELZUURZOUT; REGISTRATION NO/DATE: EU/1/15/1032 20150922 | ||||||||||||||||||||||||||
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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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