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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 Operations 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. Six 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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Summary for AVEED

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Patent Applications:	1,450
Drug Prices:	Drug price information for AVEED
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVEED
What excipients (inactive ingredients) are in AVEED?	AVEED excipients list
DailyMed Link:	AVEED at DailyMed

Drug patent expirations by year for AVEED

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVEED

Generic Entry Date for AVEED^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022219 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 Action	Androgen 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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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).

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Glossary

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1457208	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)	⤷ Sign Up
Iceland	2565		⤷ Sign Up
Mexico	PA04002395	COMPOSICIONES FARMACEUTICAS Y SU USO, PARA LOGRAR DE MANERA CONFIABLE NIVELES DE TESTOSTERONA EN SUERO, ACEPTABLES EN LA TERAPIA DE REEMPLAZO DE TESTOSTERONA. (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS.)	⤷ Sign Up
Iceland	8069	Aðferðir og lyfjasamsetningar til að ná áreiðanlega ásættanlegum testósterónstyrk	⤷ Sign Up
Russian Federation	2005131724	СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА ВСЫВОРОТКЕ	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration