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Vardenafil hydrochlorideis the generic ingredient in three branded drugs marketed by Bayer Hlthcare, Alembic Pharms Ltd, Macleods Pharms Ltd, Amneal Pharms Co, Crossmedika Sa, Teva Pharms, and Zydus Pharms, and is included in nine NDAs. There are three 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 seven patent family members in forty-three countries.
There are six drug master file entries for vardenafil hydrochloride. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for vardenafil hydrochloride
|Drug Master File Entries:||6|
|Suppliers / Packagers:||11|
|Bulk Api Vendors:||47|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for vardenafil hydrochloride|
|DailyMed Link:||vardenafil hydrochloride at DailyMed|
Recent Clinical Trials for vardenafil hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|AriBio Co., Ltd.||Phase 2|
|Tritech Biopharmaceuticals Co., Ltd.||Phase 1/Phase 2|
|A2 Healthcare Taiwan Corporation||Phase 1/Phase 2|
Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for vardenafil hydrochloride
|Drug Class||Phosphodiesterase 5 Inhibitor |
|Mechanism of Action||Phosphodiesterase 5 Inhibitors |
Paragraph IV (Patent) Challenges for VARDENAFIL HYDROCHLORIDE
|STAXYN||TABLET, ORALLY DISINTEGRATING;ORAL||vardenafil hydrochloride||200179||2011-12-22|
|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;ORAL||021400-003||Aug 19, 2003||DISCN||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Zydus Pharms||VARDENAFIL HYDROCHLORIDE||vardenafil hydrochloride||TABLET;ORAL||208960-002||Oct 31, 2018||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Amneal Pharms Co||VARDENAFIL HYDROCHLORIDE||vardenafil hydrochloride||TABLET;ORAL||210738-002||Oct 31, 2018||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Bayer Hlthcare||LEVITRA||vardenafil hydrochloride||TABLET;ORAL||021400-004||Aug 19, 2003||Start Trial||Start Trial|
|Bayer Hlthcare||STAXYN||vardenafil hydrochloride||TABLET, ORALLY DISINTEGRATING;ORAL||200179-001||Jun 17, 2010||Start Trial||Start Trial|
|Bayer Hlthcare||LEVITRA||vardenafil hydrochloride||TABLET;ORAL||021400-001||Aug 19, 2003||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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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 verification 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.