AVEED Drug Patent Profile
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When do Aveed patents expire, 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. Five 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
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: | 1,540 |
Formulation / Manufacturing: | see details |
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 |
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 Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for AVEED
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 |
---|---|---|---|
Russian Federation | 2007118196 | СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ | ⤷ Try a Trial |
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) | ⤷ 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 |
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 |
Canada | 2518910 | PROCEDES ET COMPOSITIONS PHARMACEUTIQUES POUR OBTENIR DE MANIERE FIABLE DES NIVEAUX ACCEPTABLES DE TESTOSTERONE DANS LE SERUM (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS) | ⤷ Try a Trial |
Serbia | 51537 | POSTUPCI I FARMACEUTSKI SASTAVI ZA POUZDANO POSTIZANJE PRIHVATLJIVIH NIVOA SERUMA TESTOSTERONA (METHODS AND PHARMACEUTICAL COMPOSITIONS FOR RELIABLE ACHIEVEMENT OF ACCEPTABLE SERUM TESTOSTERONE LEVELS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |