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Last Updated: February 25, 2024

AVEED Drug Patent Profile


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Which patents cover Aveed, and what generic alternatives are available?

Aveed is a drug marketed by Endo Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in thirty-eight countries.

The generic ingredient in AVEED is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.

DrugPatentWatch® Generic Entry Outlook for Aveed

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (testosterone undecanoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for AVEED
Drug Prices for AVEED

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AVEED
Generic Entry Date for AVEED*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INTRAMUSCULAR

*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.

Pharmacology for AVEED
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Paragraph IV (Patent) Challenges for AVEED
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVEED Injection testosterone undecanoate 250 mg/mL 022219 1 2014-06-11

US Patents and Regulatory Information for AVEED

AVEED is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AVEED is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AVEED

Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Endo Pharms Inc AVEED testosterone undecanoate INJECTABLE;INTRAMUSCULAR 022219-001 Mar 5, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AVEED

See the table below for patents covering AVEED around the world.

Country Patent Number Title Estimated Expiration
Chile 2004000527 COMPOSICION FARMACEUTICA PARA INYECCION INTRAMUSCULAR QUE COMPRENDE UN ESTER DE TESTOSTERONA, 25 A 45% V/V DE ACEITE DE RICINO COMO VEHICULO Y UN COSOLVENTE, FORMULACION FARMACEUTICA, Y USO. ⤷  Try a Trial
Eurasian Patent Organization 200501819 СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ ⤷  Try a Trial
Japan 2006520377 ⤷  Try a Trial
European Patent Office 1743646 Procédés et compositions pour atteindre avec fiabilité à un niveau de testostérone acceptable dans le sérum (Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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