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Last Updated: October 23, 2019

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ALTABAX Drug Profile

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When do Altabax patents expire, and when can generic versions of Altabax launch?

Altabax is a drug marketed by Almirall and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-nine patent family members in thirty-five countries.

The generic ingredient in ALTABAX is retapamulin. One supplier is listed for this compound. Additional details are available on the retapamulin profile page.

Summary for ALTABAX
Drug patent expirations by year for ALTABAX
Drug Prices for ALTABAX

See drug prices for ALTABAX

Generic Entry Opportunity Date for ALTABAX
Generic Entry Date for ALTABAX*:
Constraining patent/regulatory exclusivity:
NDA:
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 ALTABAX

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

SponsorPhase
University of California, IrvinePhase 4
Agency for Healthcare Research and Quality (AHRQ)Phase 4
The University of Texas Health Science Center, HoustonPhase 4

See all ALTABAX clinical trials

Pharmacology for ALTABAX
Synonyms for ALTABAX
(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 (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
Retapamulin [USAN:INN:BAN]
RL02708
s4056
SB 275833
SB-275833
SCHEMBL365459
ST24025747
UNII-4MG6O8991R
ZINC100013500
ZINC103660515
ZINC3931840

US Patents and Regulatory Information for ALTABAX

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 Y Y   Start Trial
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   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 ALTABAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1028961 C01028961/01 Switzerland   Start Trial PRODUCT NAME: RETAPAMULIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58641 04.08.2009
1028961 SPC042/2007 Ireland   Start Trial SPC042/2007: 20080415, EXPIRES: 20220523
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
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 306 Finland   Start Trial
1028961 CA 2007 00052 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
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Dow
Harvard Business School
Merck
Baxter

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