.

Deeper Knowledge, Faster

  • Find suppliers and generic API sources
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

► See Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Medtronic
Argus Health
Daiichi Sankyo
QuintilesIMS
Fuji
Colorcon
Federal Trade Commission
US Department of Justice

Generated: June 23, 2017

DrugPatentWatch Database Preview

Vardenafil hydrochloride - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for vardenafil hydrochloride and what is the scope of vardenafil hydrochloride patent protection?

Vardenafil hydrochloride
is the generic ingredient in three branded drugs marketed by Bayer Hlthcare, Teva Pharms, and Watson Labs Teva, and is included in four NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Vardenafil hydrochloride has one hundred and seventy-three patent family members in fifty-six countries.

There are five drug master file entries for vardenafil hydrochloride. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: vardenafil hydrochloride

Tradenames:3
Patents:6
Applicants:3
NDAs:4
Drug Master File Entries: see list5
Suppliers / Packagers: see list6
Bulk Api Vendors: see list112
Clinical Trials: see list2,321
Patent Applications: see list3,182
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:vardenafil hydrochloride at DailyMed

Pharmacology for Ingredient: vardenafil hydrochloride

Tentative approvals for VARDENAFIL HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2.5MGTABLET;ORAL
► Subscribe► Subscribe20MGTABLET;ORAL
► Subscribe► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-004Aug 19, 2003ABRXYesYes6,362,178► SubscribeYY ► Subscribe
Teva Pharms
VARDENAFIL HYDROCHLORIDE
vardenafil hydrochloride
TABLET;ORAL091347-004May 3, 2012ABRXNoNo► Subscribe► Subscribe
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-004Aug 19, 2003ABRXYesYes8,841,446► SubscribeY ► Subscribe
Bayer Hlthcare
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010ABRXYesYes8,613,950► SubscribeY ► Subscribe
Bayer Hlthcare
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010ABRXYesYes6,362,178► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: vardenafil hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,314,8712-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors, for treatment of hypertension► Subscribe
6,566,360 2-phenyl substituted imidatriazinones as phosphodiesterase inhibitors► Subscribe
7,704,9992-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
7,122,5402-Phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
6,890,922 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: vardenafil hydrochloride

Country Document Number Estimated Expiration
Morocco27320► Subscribe
Australia2003249942► Subscribe
TaiwanI387465► Subscribe
Spain2194567► Subscribe
China102198140► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
Novartis
AstraZeneca
Medtronic
Dow
Queensland Health
Healthtrust
Cipla
Teva
Chinese Patent Office

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot