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Generated: September 24, 2017
What is the patent landscape for Clindagel, and what generic Clindagel alternatives are available?
Clindagel is a drug marketed by Precision Dermat and is included in one NDA. There is one patent protecting this drug.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 22 |
| Clinical Trials: see list | 1 |
| Patent Applications: see list | 1,078 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | CLINDAGEL at DailyMed |
| Ingredient-type | Lincosamides |
| Drug Class | Lincosamide Antibacterial |
| Physiological Effect | Decreased Sebaceous Gland Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Precision Dermat | CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782-001 | Nov 27, 2000 | BT | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,517,847 | Topical gel delivery system | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2251410 | ► Subscribe | |||||||||||||
| China | 1460013 | ► Subscribe | |||||||||||||
| Mexico | PA03001006 | ► Subscribe | |||||||||||||
| Poland | 360589 | ► Subscribe | |||||||||||||
| Portugal | 1304992 | ► Subscribe | |||||||||||||
| China | 101305982 | ► Subscribe | |||||||||||||
| Portugal | 2052714 | ► Subscribe | |||||||||||||
| Germany | 60138549 | ► Subscribe | |||||||||||||
| Austria | 429922 | ► Subscribe | |||||||||||||
| Slovenia | 1304992 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1304992/01 | Switzerland | ► Subscribe | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 | ||||||||||||
| 2013025 | Lithuania | ► Subscribe | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 | ||||||||||||
| 401 | Luxembourg | ► Subscribe | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE | ||||||||||||
| 90049-3 | Sweden | ► Subscribe | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 | ||||||||||||
| 2013025,C1304992 | Lithuania | ► Subscribe | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 | ||||||||||||
| 2013 00053 | Denmark | ► Subscribe | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 | ||||||||||||
| 00617 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322 | ||||||||||||
| 4 | Finland | ► Subscribe | |||||||||||||
| 13/044 | Ireland | ► Subscribe | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 | ||||||||||||
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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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