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Last Updated: March 19, 2024

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, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms, and is included in ten NDAs. There are two 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. Thirteen 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
Astellas Pharma US, Inc.Phase 1/Phase 2

See all vardenafil hydrochloride clinical trials

Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Try a Trial⤷  Try a 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 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
Zydus Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960-002 Oct 31, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-003 Aug 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-002 Aug 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Stevens J VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 210738-002 Oct 31, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-001 Aug 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-004 Aug 4, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare STAXYN vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 200179-001 Jun 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for vardenafil hydrochloride

Country Patent Number Title Estimated Expiration
Slovenia 2272505 ⤷  Try a Trial
Japan 5122984 ⤷  Try a Trial
Russian Federation 2481110 ЛЕКАРСТВЕННЫЕ ФОРМЫ С УЛУЧШЕННЫМИ ФАРМАКОКИНЕТИЧЕСКИМИ СВОЙСТВАМИ (DOSAGE FORMS WITH IMPROVED PHARMACOKINETIC PROPERTIES) ⤷  Try a Trial
Mexico 2007010527 FORMAS FARMACEUTICAS CON PROPIEDADES FARMACOCINETICAS MEJORADAS. (PHARMACEUTICAL FORMS WITH IMPROVED PHARMACOKINETIC PROPERTIES.) ⤷  Try a Trial
South Africa 200707320 Pharmaceutical forms with improved pharmacokinetic properties ⤷  Try a Trial
Peru 20061015 FORMAS FARMACEUTICAS CON PROPIEDADES FARMACOCINETICAS MEJORADAS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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