Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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Generated: September 22, 2019

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Testosterone undecanoate - Generic Drug Details

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What are the generic drug sources for testosterone undecanoate and what is the scope of testosterone undecanoate patent protection?

Testosterone undecanoate is the generic ingredient in two branded drugs marketed by Clarus and Endo Pharms Inc, and is included in two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Testosterone undecanoate has seventy-five patent family members in thirty-seven countries.

There are sixty-nine drug master file entries for testosterone undecanoate. One supplier is listed for this compound.

Pharmacology for testosterone undecanoate
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Synonyms for testosterone undecanoate
(17-beta)-3-Oxoandrost-4-en-17-yl undecanoate
(17|A)-17-[(1-| xoundecyl)oxy]androst-4-en-3-one
(17beta)-3-Oxoandrost-4-en-17-yl undecanoate
(1S,2R,10R,11S,14S,15S)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-14-yl undecanoate
(1S,2R,10R,11S,14S,15S)-2,15-dimethyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-14-yl undecanoate
[(8R,9S,10R,13S,14S,17S)-10,13-dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate
17beta-Hydroxyandrost-4-en-3-one undecanoate
3-Oxoandrost-4-en-17beta-yl undecanoate
4-08-00-00981 (Beilstein Handbook Reference)
5-.alpha.-Androstan-3-one, 17-.beta.-hydroxy-, undecanoate
5-alpha-Androstan-3-one, 17-beta-hydroxy-, undecanoate
5949-44-0
949T440
AC1L22PV
AKOS016010255
AN-11881
Andriol
Andriol (TN)
Andriol Testocaps
Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17-beta)-
Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-, (17beta)-
Androst-4-en-3-one, 17-((1-oxoundecyl)oxy)-(17beta)
Androst-4-en-3-one, 17-[(1-oxoundecyl)oxy]-, (17.beta.)-
Aveed
BAY 86-5037
BCP11921
BRN 3176734
C-22555
CC-34823
CHEBI:135741
CHEMBL2107067
CLR-610
CS-4342
D06087
EINECS 227-712-6
GS-6598
H16A5VCT9C
HY-B0626
Jatenzo
LS-148824
MolPort-003-850-422
Nebido
Nebido-R
Org 538
ORG-538
Pantestone
Reandron 1000
Restandol
Rextoro
SC-16124
SCHEMBL147620
T undecanoate
Testosterone (undecanoate)
Testosterone undecanoate (USAN)
Testosterone undecanoate [USAN]
Testosterone Undeconate
Testosterone undecylate
Testosterone, undecanoate
Testosterone, undecanoate (ester)
UDSFVOAUHKGBEK-CNQKSJKFSA-N
Undestor
UNII-H16A5VCT9C
W-105318
ZINC8214690

US Patents and Regulatory Information for testosterone undecanoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
Clarus JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes   Try a Free Trial   Try a Free Trial Y   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Chubb
AstraZeneca
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Mallinckrodt

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.