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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 freedom to operate?

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

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

Summary for testosterone undecanoate

US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	65
Suppliers / Packagers:	1
Bulk Api Vendors:	42
Clinical Trials:	39
Patent Applications:	1,051
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for testosterone undecanoate
DailyMed Link:	testosterone undecanoate at DailyMed

Pharmacology for testosterone undecanoate

Ingredient-type	Androstanes
Drug Class	Androgen
Mechanism of Action	Androgen 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

(1S,2R,10R,11S,14S,15S)-2,15-DIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]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

AK115043

AKOS016010255

Ambotz105300-28-5

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.)-

BAY 86-5037

BRN 3176734

C-22555

CC-34823

CHEBI:135741

CHEMBL2107067

CLR-610

CS-4342

D02AXG

D06087

EINECS 227-712-6

GS-6598

H16A5VCT9C

HY-B0626

Jatenzo

LP095070

LS-148824

MFCD00468114

MolPort-003-850-422

Nebido

Nebido-R

Org 538

ORG-538

Pantestone

PL000411

Reandron 1000

Restandol

Restandol (TN)

Rextoro

SC-16124

SCHEMBL147620

T undecanoate

Testosterone (undecanoate)

Testosterone undecanoate (USAN)

Testosterone undecanoate [USAN]

Testosterone Undeconate

Testosterone undecylate

Testosterone, undecanoate

Testosterone, undecanoate (ester)

Testosteroneundecanoate

Testrosterone undecanoate

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
Endo Pharms Inc	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes
Endo Pharms Inc	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes			Y

International Patents for testosterone undecanoate

Country	Document Number	Estimated Expiration
Canada	2518910
Portugal	1457208
Slovenia	1457208
Russian Federation	2005131724
Eurasian Patent Organization	200501819
Norway	335179
Costa Rica	7999