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Retapamulin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for retapamulin?

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

Retapamulin has sixty-three patent family members in thirty-five countries.

Three suppliers are listed for this compound.

Summary for Generic Name: retapamulin

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list34
Clinical Trials: see list7
Patent Applications: see list331
Therapeutic Class:Antibacterials
Drug Prices:see low prices
DailyMed Link:retapamulin at DailyMed

Pharmacology for Ingredient: retapamulin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYes8,207,191► Subscribe ► Subscribe
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYesRE43390► SubscribeYY ► Subscribe
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYes7,875,630► SubscribeY ► Subscribe
Aqua Pharms Llc
ALTABAX
retapamulin
OINTMENT;TOPICAL022055-001Apr 12, 2007RXYesYesRE39128► 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
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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
Portugal1028961► Subscribe
Poland197672► Subscribe
Norway20002173► Subscribe
Egypt24177► Subscribe
Poland191927► 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
6Finland► Subscribe
C042/2007Ireland► SubscribeSPC042/2007: 20080415, EXPIRES: 20220523
372Luxembourg► Subscribe91372, EXPIRES: 20220524
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
1028961/01Switzerland► SubscribePRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
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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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