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Last Updated: September 27, 2020

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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 patent protection?

Vardenafil hydrochloride is 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for vardenafil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AriBio Co., Ltd.Phase 2
A2 Healthcare Taiwan CorporationPhase 1/Phase 2
Tritech Biopharmaceuticals Co., Ltd.Phase 1/Phase 2

See all vardenafil hydrochloride clinical trials

Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET, ORALLY DISINTEGRATING;ORAL
  Start Trial  Start Trial10MGTABLET, ORALLY DISINTEGRATING;ORAL

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
Paragraph IV (Patent) Challenges for VARDENAFIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
STAXYN TABLET, ORALLY DISINTEGRATING;ORAL vardenafil hydrochloride 200179 2011-12-22
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-09-04
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-07-10
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-03-05

US Patents and Regulatory Information for vardenafil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 091347-002 May 3, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960-003 Oct 31, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-002 Aug 4, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960-004 Oct 31, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 210738-003 Oct 31, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for vardenafil hydrochloride

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   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Express Scripts
Dow
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Medtronic

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