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Last Updated: December 5, 2019

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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 patent protection?

Retapamulin is the generic ingredient in one branded drug marketed by Almirall 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.

One supplier is listed for this compound.

Summary for retapamulin
International Patents:69
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 54
Clinical Trials: 16
Patent Applications: 521
DailyMed Link:retapamulin at DailyMed
Recent Clinical Trials for retapamulin

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

SponsorPhase
New York University School of MedicinePhase 3
GlaxoSmithKlinePhase 1
University of California, IrvinePhase 4

See all retapamulin clinical trials

Pharmacology for retapamulin
Synonyms for retapamulin
(1S,2R,3S,4S,6R,7R,8R,14R)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxotricyclo[5.4.3.0;{1,8}]tetradecan-6-yl 2-{[(1R,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl]sulfanyl}acetate
(3aS,4R,5S,6S,8R,9R,9aR,10R)-2-(exo-8-Methyl-8-azabicyclo[3.2.1]octan-3-ylsulfanyl)acetic acid 5-hydroxy-4,6,9,10-tetraMethyl-1-oxo-6-vinylperhydro-3a,9-propanocyclopentacycloocten-8-yl ester (RETAPAMULIN)
(3as,4r,5s,6s,8r,9r,9ar,10r)-5-Hydroxy-4,6,9,10-Tetramethyl-1-Oxo-6-Vinyldecahydro-3a,9-Propanocyclopenta[8]annulen-8-Yl {[(3-Exo)-8-Methyl-8-Azabicyclo[3.2.1]oct-3-Yl]thio}acetate
(3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propanocyclopenta[8]annulen-8-yl {[(3-exo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl]sulfanyl}acetate
224452-66-8
345632-67-9
452R668
4MG6O8991R
AB01566905_01
AKOS016008865
AKOS030485971
Altabax
Altabax (Glaxo)
Altargo
AN-607
AS-11455
BC677692
BRD-K33082088-001-03-3
C30H47NO4S
CHEMBL1658
CR0022
CS-0618
DB01256
HY-17010
MolPort-023-220-081
MP-0763
NCGC00386248-01
Retapamulin [USAN:INN:BAN]
RL02708
s4056
SB 275833
SB-275833
SCHEMBL365459
ST24025747
UNII-4MG6O8991R
ZINC100013500
ZINC103660515
ZINC3931840

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

Supplementary Protection Certificates for retapamulin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1028961 306 Finland   Start Trial
1028961 07C0057 France   Start 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
1028961 91372 Luxembourg   Start Trial 91372, EXPIRES: 20220524
1028961 C01028961/01 Switzerland   Start Trial PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
1028961 SPC/GB07/061 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKesson
Baxter
Colorcon
Merck

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