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Last Updated: November 2, 2024

Vardenafil hydrochloride - Generic Drug Details


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What are the generic sources for vardenafil hydrochloride and what is the scope of freedom to operate?

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

Summary for vardenafil hydrochloride
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
⤷  Sign Up⤷  Sign Up10MGTABLET, ORALLY DISINTEGRATING;ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET, 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Crossmedika Sa VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 209057-003 Oct 31, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 204632-001 Oct 22, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 091347-001 May 3, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-002 Aug 4, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 091347-004 May 3, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960-003 Oct 31, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-004 Aug 4, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 021400-003 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare STAXYN vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 200179-001 Jun 17, 2010 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for vardenafil hydrochloride

Country Patent Number Title Estimated Expiration
South Africa 200707320 Pharmaceutical forms with improved pharmacokinetic properties ⤷  Sign Up
Costa Rica 20130381 FORMAS FARMACÉUTICAS CON PROPIEDADES FARMACOCINÉTICAS MEJORADAS ⤷  Sign Up
Cyprus 1112460 ⤷  Sign Up
Croatia P20131002 LIJEKOVI KOJI SADRŽAVAJU VARDENAFIL HIDROKLORID TRIHIDRAT (PHARMACEUTICAL COMPOSITIONS CONTAINING VARDENAFIL HYDROCHLORIDE TRIHYDRATE) ⤷  Sign Up
Israel 232538 ⤷  Sign Up
Japan 5173113 ⤷  Sign Up
Norway 20050578 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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