Aveed is a drug owned by Endo Operations Ltd. It is protected by 2 US drug patents filed in 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 08, 2027. Details of Aveed's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7718640 | Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels |
Mar, 2027
(2 years from now) | Active |
| US8338395 | Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels |
May, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aveed's patents.
Latest Legal Activities on Aveed's Patents
Given below is the list of recent legal activities going on the following patents of Aveed.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jun, 2024 | US8338395 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Nov, 2021 | US7718640 |
| Patent Term Extension Certificate | 19 Aug, 2020 | US8338395 |
| Notice of Final Determination -Eligible | 29 Jun, 2020 | US8338395 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jun, 2020 | US8338395 |
| Change in Power of Attorney (May Include Associate POA) | 06 Dec, 2019 | US8338395 |
| Email Notification | 06 Dec, 2019 | US8338395 |
| Correspondence Address Change | 05 Dec, 2019 | US8338395 |
| FDA Final Eligibility Letter | 23 May, 2019 | US8338395 |
| Change in Power of Attorney (May Include Associate POA) | 04 Sep, 2018 | US8338395 |
FDA has granted several exclusivities to Aveed. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aveed, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Aveed.
Exclusivity Information
Aveed holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Aveed's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 05, 2017 |
US patents provide insights into the exclusivity only within the United States, but Aveed is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aveed's family patents as well as insights into ongoing legal events on those patents.
Aveed's family patents
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Generic Launch
Generic Release Date:
Aveed's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 08, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aveed Generics:
There are no approved generic versions for Aveed as of now.
How can I launch a generic of Aveed before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aveed's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aveed's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Aveed -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg/mL | 11 Jun, 2014 | 1 | 14 Mar, 2027 |
About Aveed
Aveed is a drug owned by Endo Operations Ltd. It is used for treating conditions associated with deficiency or absence of endogenous testosterone in adult males, including primary hypogonadism and hypogonadotropic hypogonadism. Aveed uses Testosterone Undecanoate as an active ingredient. Aveed was launched by Endo Operations in 2014.
Market Authorisation Date:
Aveed was approved by FDA for market use on 05 March, 2014.
Active Ingredient:
Aveed uses Testosterone Undecanoate as the active ingredient. Check out other Drugs and Companies using Testosterone Undecanoate ingredient
Treatment:
Aveed is used for treating conditions associated with deficiency or absence of endogenous testosterone in adult males, including primary hypogonadism and hypogonadotropic hypogonadism.
Dosage:
Aveed is available in injectable form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 750MG/3ML (250MG/ML) | INJECTABLE | Prescription | INTRAMUSCULAR |