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Last Updated: September 25, 2022

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. Three 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

See drug prices for AVEED

DrugPatentWatch® Estimated Generic Entry Opportunity 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 Class Androgen
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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Endo Pharms Inc AVEED testosterone undecanoate INJECTABLE;INTRAMUSCULAR 022219-001 Mar 5, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

When does loss-of-exclusivity occur for AVEED?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3603
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04218893
Estimated Expiration: See Plans and Pricing

Austria

Patent: 6251
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0400214
Estimated Expiration: See Plans and Pricing

Canada

Patent: 18910
Estimated Expiration: See Plans and Pricing

Chile

Patent: 04000527
Estimated Expiration: See Plans and Pricing

China

Patent: 61469
Estimated Expiration: See Plans and Pricing

Patent: 1884639
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 00724
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 99
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0050781
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 57208
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 056095
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1568
Estimated Expiration: See Plans and Pricing

Patent: 0501819
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 57208
Estimated Expiration: See Plans and Pricing

Patent: 43646
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004001893
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 69325
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 65
Estimated Expiration: See Plans and Pricing

Patent: 69
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0473
Estimated Expiration: See Plans and Pricing

Japan

Patent: 80891
Estimated Expiration: See Plans and Pricing

Patent: 06520377
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 05
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 04002395
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 149
Estimated Expiration: See Plans and Pricing

Patent: 4508
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2321
Estimated Expiration: See Plans and Pricing

Norway

Patent: 5179
Estimated Expiration: See Plans and Pricing

Patent: 054711
Estimated Expiration: See Plans and Pricing

Peru

Patent: 041065
Estimated Expiration: See Plans and Pricing

Poland

Patent: 57208
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 57208
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 54381
Estimated Expiration: See Plans and Pricing

Patent: 05131724
Estimated Expiration: See Plans and Pricing

Patent: 07118196
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 31
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 537
Estimated Expiration: See Plans and Pricing

Patent: 050702
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 57208
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0508313
Estimated Expiration: See Plans and Pricing

Patent: 0700046
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0882378
Estimated Expiration: See Plans and Pricing

Patent: 050109561
Estimated Expiration: See Plans and Pricing

Patent: 080096717
Estimated Expiration: See Plans and Pricing

Spain

Patent: 71772
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 45976
Estimated Expiration: See Plans and Pricing

Patent: 0511997
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 510
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 231
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
South Africa 200508313 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels See Plans and Pricing
Spain 2271772 See Plans and Pricing
Ukraine 82510 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ И ИХ ПРИМЕНЕНИЕ;ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ДЛЯ ДОСТОВІРНОГО ДОСЯГНЕННЯ ПРИЙНЯТНИХ РІВНІВ ТЕСТОСТЕРОНУ В СИРОВАТЦІ ТА ЇХ ЗАСТОСУВАННЯ (PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS AND USE THEREOF) See Plans and Pricing
Taiwan 200511997 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels See Plans and Pricing
China 101884639 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels See Plans and Pricing
Montenegro P14508 POSTUPCI I FARMACEUTSKI SASTAVI ZA POUZDANO POSTIZANJE PRIHVATLJIVIH NIVOA SERUMA TESTOSTERONA (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.