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Last Updated: March 28, 2024

RETAPAMULIN - Generic Drug Details


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What are the generic drug sources for retapamulin and what is the scope of freedom to operate?

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

Retapamulin has thirteen patent family members in six countries.

One supplier is listed for this compound.

Summary for RETAPAMULIN
International Patents:13
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 16
Patent Applications: 1,254
What excipients (inactive ingredients) are in RETAPAMULIN?RETAPAMULIN excipients list
DailyMed Link:RETAPAMULIN at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RETAPAMULIN
Generic Entry Date for RETAPAMULIN*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RETAPAMULIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU Langone HealthPhase 3
New York University School of MedicinePhase 3
GlaxoSmithKlinePhase 1

See all RETAPAMULIN clinical trials

Pharmacology for RETAPAMULIN

US Patents and Regulatory Information for RETAPAMULIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Almirall ALTABAX retapamulin OINTMENT;TOPICAL 022055-001 Apr 12, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RETAPAMULIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Glaxo Group Ltd Altargo retapamulin EMEA/H/C/000757
Short term treatment of the following superficial skin infections:, , , impetigo;, infected small lacerations, abrasions or sutured wounds., , , See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus., , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,
Withdrawn no no no 2007-05-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RETAPAMULIN

Country Patent Number Title Estimated Expiration
European Patent Office 2181995 Sels et forme crystalline de mutilin 14-(exo-8-methyl-8-azabicyclo[3.2.1]oct-3-yl-sufanyl)-acetate (Salts and crystalline form of mutilin 14-(exo-8-methyl-8-azabicyclo[3.2.1]oct-3-yl-sufanyl)-acetate) ⤷  Try a Trial
European Patent Office 1663220 NOUVEAU PROCEDE POUR LA FABRICATION DE DERIVES DE LA PLEUROMUTILINE (NOVEL PROCESS FOR THE PREPARATION OF PLEUROMUTILIN DERIVATIVES) ⤷  Try a Trial
Germany 602004024417 ⤷  Try a Trial
Spain 2335284 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005023257 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RETAPAMULIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1028961 C01028961/01 Switzerland ⤷  Try a Trial PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
1028961 SPC/GB07/061 United Kingdom ⤷  Try a Trial PRODUCT 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 07C0057 France ⤷  Try a Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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