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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Chinese Patent Office
Julphar
Colorcon
Chubb
Fuji
AstraZeneca
Cantor Fitzgerald
US Army

Generated: December 18, 2017

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Vardenafil hydrochloride - Generic Drug Details

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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 and Teva Pharms, and is included in three NDAs. There are five 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 ninety-two patent family members in fifty-seven 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.

Pharmacology for vardenafil hydrochloride

Tentative approvals for VARDENAFIL HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe2.5MGTABLET;ORAL
u► Subscribe20MGTABLET;ORAL
u► 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 HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-004Aug 19, 2003ABRXYesYes► Subscribe► SubscribeYY► Subscribe
Teva PharmsVARDENAFIL HYDROCHLORIDEvardenafil hydrochlorideTABLET;ORAL091347-001May 3, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-001Aug 19, 2003ABRXYesNo► Subscribe► SubscribeYY► Subscribe
Bayer HlthcareSTAXYNvardenafil hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-003Aug 19, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-002Aug 19, 2003ABRXYesNo► Subscribe► SubscribeYY► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-004Aug 19, 2003ABRXYesYes► Subscribe► SubscribeY► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-001Aug 19, 2003ABRXYesNo► Subscribe► SubscribeYY► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-002Aug 19, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Bayer HlthcareLEVITRAvardenafil hydrochlorideTABLET;ORAL021400-004Aug 19, 2003ABRXYesYes► Subscribe► SubscribeYY► Subscribe
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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
7,704,9992-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
6,566,360 2-phenyl substituted imidatriazinones as phosphodiesterase inhibitors► Subscribe
7,314,8712-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors, for treatment of hypertension► Subscribe
7,122,5402-Phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
6,890,922 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
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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.

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International Patent Family for Ingredient: vardenafil hydrochloride

Country Document Number Estimated Expiration
Hungary0100394► Subscribe
CroatiaP20000292► Subscribe
Australia2003249942► Subscribe
Morocco29376► Subscribe
Turkey200001338► Subscribe
Hong Kong1118457► Subscribe
Denmark1523303► Subscribe
Russian Federation2260593► Subscribe
Israel135462► Subscribe
Taiwan200640503► Subscribe
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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.

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Serving leading biopharmaceutical companies globally:

Cipla
McKinsey
Queensland Health
Baxter
Cerilliant
Teva
Harvard Business School
Citi
Boehringer Ingelheim
Healthtrust

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.

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