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Testosterone undecanoate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for testosterone undecanoate?

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

Testosterone undecanoate has forty-five patent family members in thirty-six countries.

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

Summary for Generic Name: testosterone undecanoate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list61
Suppliers / Packagers: see list1
Bulk Api Vendors: see list35
Clinical Trials: see list293
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:testosterone undecanoate at DailyMed

Pharmacology for Ingredient: testosterone undecanoate

Ingredient-typeAndrostanes
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms Inc
AVEED
testosterone undecanoate
INJECTABLE;INTRAMUSCULAR022219-001Mar 5, 2014RXYesYes► Subscribe► Subscribe
Endo Pharms Inc
AVEED
testosterone undecanoate
INJECTABLE;INTRAMUSCULAR022219-001Mar 5, 2014RXYesYes7,718,640► SubscribeY ► Subscribe
Endo Pharms Inc
AVEED
testosterone undecanoate
INJECTABLE;INTRAMUSCULAR022219-001Mar 5, 2014RXYesYes8,338,395► Subscribe ► Subscribe
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International Patent Family for Ingredient: testosterone undecanoate

Country Document Number Estimated Expiration
EcuadorSP056095► Subscribe
Ukraine82510► Subscribe
Israel170473► Subscribe
Hong Kong1069325► Subscribe
Russian Federation2007118196► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 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.

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