Retapamulin - Generic Drug Details

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What are the generic 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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
NYU Langone Health	Phase 3
New York University School of Medicine	Phase 3
GlaxoSmithKline	Phase 1

See all retapamulin clinical trials

Pharmacology for retapamulin

Drug Class	Pleuromutilin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for retapamulin

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for retapamulin

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Glossary

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

Expired US Patents for retapamulin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	⤷ Sign Up	⤷ Sign Up
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	⤷ Sign Up	⤷ Sign Up
Almirall	ALTABAX	retapamulin	OINTMENT;TOPICAL	022055-001	Apr 12, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for retapamulin

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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

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Country	Patent Number	Title	Estimated Expiration
Germany	602004024417		⤷ Sign Up
European Patent Office	1663220	NOUVEAU PROCEDE POUR LA FABRICATION DE DERIVES DE LA PLEUROMUTILINE (NOVEL PROCESS FOR THE PREPARATION OF PLEUROMUTILIN DERIVATIVES)	⤷ Sign Up
Japan	5685156		⤷ Sign Up
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)	⤷ Sign Up
Japan	2015013882	新規調製方法、塩、組成物及び使用 (NOVEL PREPARATION PROCESS, SALTS, COMPOSITION AND USE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for retapamulin

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