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Serving leading biopharmaceutical companies globally:

Argus Health
McKinsey
Deloitte
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Generated: November 23, 2017

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Retapamulin - Generic Drug Details

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What are the generic drug sources for retapamulin and what is the scope of retapamulin patent protection?

Retapamulin
is the generic ingredient in one branded drug marketed by Aqua Pharms Llc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Retapamulin has sixty-nine patent family members in thirty-five countries and seven supplementary protection certificates in seven countries.

Three suppliers are listed for this compound.

Summary for retapamulin

Pharmacology for retapamulin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: retapamulin

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
6,281,226 Pleuromutilin derivatives as antimicrobials► Subscribe
RE39128Pleuromutilin derivatives as antimicrobials► 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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International Patent Family for Ingredient: retapamulin

Country Document Number Estimated Expiration
Austria525373► Subscribe
Japan2012236850► Subscribe
Czech Republic20001551► Subscribe
Norway20002173► Subscribe
Slovenia1930330► Subscribe
TaiwanI232861► Subscribe
Denmark1930330► Subscribe
Argentina015987► Subscribe
Australia742167► Subscribe
Malaysia130665► 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 Certificates for Tradename: RETAPAMULIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0057France► SubscribePRODUCT NAME: RETAPAMULIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/390/001 DU 20070524; REGISTRATION NO/DATE AT EEC: EU/1/07/390/001 DU 20070524
6Finland► Subscribe
372Luxembourg► Subscribe91372, EXPIRES: 20220524
C042/2007Ireland► SubscribeSPC042/2007: 20080415, EXPIRES: 20220523
2007 00052Denmark► Subscribe
1028961/01Switzerland► SubscribePRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
C/GB07/061United Kingdom► SubscribePRODUCT NAME: RETAPAMULIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/390/001 20070524; UK EU/1/07/390/002 20070524; UK EU/1/07/390/003 20070524; UK EU/1/07/390/004 20070524
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
Fuji
Argus Health
Novartis
Citi
Moodys
Dow
Boehringer Ingelheim
Daiichi Sankyo
Julphar

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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