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STAXYN Drug Profile

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Staxyn is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-eight patent family members in fifty-three countries.

The generic ingredient in STAXYN is vardenafil hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for Tradename: STAXYN

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: STAXYN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010RXYes6,362,178► subscribe ► subscribe
Bayer Hlthcare
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010RXYes7,696,206► subscribe ► subscribe
Bayer Hlthcare
STAXYN
vardenafil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL200179-001Jun 17, 2010RXYes8,613,950► subscribeY ► subscribe
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Paragraph IV activity for: STAXYN

Drugname Dosage Strength RLD Submissiondate
vardenafil hydrochlorideOrally Disintegrating Tablets10 mgStaxyn12/22/2011

Non-Orange Book Patents for Tradename: STAXYN

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
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
7,704,9992-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 Tradename: STAXYN

Country Document Number Estimated Expiration
Japan5122984► subscribe
European Patent Office1858490► subscribe
Russian Federation2423970► 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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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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