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Last Updated: January 30, 2023

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 eight 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.

Recent Clinical Trials for vardenafil hydrochloride

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

SponsorPhase
AriBio Co., Ltd.Phase 3
Respira Therapeutics, Inc.Phase 1
Johns Hopkins UniversityPhase 1/Phase 2

See all vardenafil hydrochloride clinical trials

Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10MGTABLET, ORALLY DISINTEGRATING;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET, 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 Strength NDA ANDAs Submitted Submissiondate
STAXYN Orally Disintegrating Tablets vardenafil hydrochloride 10 mg 200179 1 2011-12-22
LEVITRA Tablets vardenafil hydrochloride 2.5 mg 021400 1 2009-09-04
LEVITRA Tablets vardenafil hydrochloride 5 mg and 10 mg 021400 1 2009-07-10
LEVITRA Tablets vardenafil hydrochloride 20 mg 021400 1 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
Amneal Pharms Co VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 210738-003 Oct 31, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Macleods Pharms Ltd VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 204632-004 Oct 22, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-002 Aug 4, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for vardenafil hydrochloride

Country Patent Number Title Estimated Expiration
Russian Federation 2007135982 ЛЕКАРСТВЕННЫЕ ФОРМЫ С УЛУЧШЕННЫМИ ФАРМАКОКИНЕТИЧЕСКИМИ СВОЙСТВАМИ See Plans and Pricing
Germany 10232113 Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel See Plans and Pricing
Costa Rica 9339 FORMAS FARMACEUTICAS CON PROPIEDADES FARMACOCINETICAS MEJORADAS See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.