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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 ten 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. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for vardenafil hydrochloride
|Drug Master File Entries:||6|
|Finished Product Suppliers / Packagers:||12|
|Raw Ingredient (Bulk) Api Vendors:||52|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for vardenafil hydrochloride|
|What excipients (inactive ingredients) are in vardenafil hydrochloride?||vardenafil hydrochloride excipients list|
|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|
|A2 Healthcare Taiwan Corporation||Phase 1/Phase 2|
|Tritech Biopharmaceuticals Co., Ltd.||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|
|Zydus Pharms||VARDENAFIL HYDROCHLORIDE||vardenafil hydrochloride||TABLET;ORAL||208960-001||Oct 31, 2018||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Crossmedika Sa||VARDENAFIL HYDROCHLORIDE||vardenafil hydrochloride||TABLET;ORAL||209057-002||Oct 31, 2018||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Teva Pharms||VARDENAFIL HYDROCHLORIDE||vardenafil hydrochloride||TABLET;ORAL||091347-002||May 3, 2012||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever 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||STAXYN||vardenafil hydrochloride||TABLET, ORALLY DISINTEGRATING;ORAL||200179-001||Jun 17, 2010||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Bayer Hlthcare||LEVITRA||vardenafil hydrochloride||TABLET;ORAL||021400-004||Aug 19, 2003||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Bayer Hlthcare||LEVITRA||vardenafil hydrochloride||TABLET;ORAL||021400-001||Aug 19, 2003||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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