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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Questions you can ask:
- What is the 5 year forecast for AVEED?
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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 |
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 |
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).
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2007118196 | СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ | ⤷ Sign Up |
Saudi Arabia | 1931 | طريقة وتركيبات صيدلية pharmaceutical compositions للحصول على مستويات تستوستيرون testosterone مقبولة ويعتمد عليها | ⤷ Sign Up |
Eurasian Patent Organization | 200501819 | СПОСОБЫ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ДОСТОВЕРНОГО ДОСТИЖЕНИЯ ПРИЕМЛЕМЫХ УРОВНЕЙ ТЕСТОСТЕРОНА В СЫВОРОТКЕ | ⤷ Sign Up |
Taiwan | I345976 | ⤷ Sign Up | |
Colombia | 5700724 | METODOS Y COMPOSICIONES FARMACEUTICAS PARA LA OBTENCION CONFIABLE DE NIVELES ACEPTABLES DE TESTOSTERONA EN SUERO | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |