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

International Patents:	107
US Patents:	2
Tradenames:	3
Applicants:	7
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	82
Patent Applications:	21
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

Sponsor	Phase
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
⤷ Sign Up	⤷ Sign Up	10MG	TABLET, ORALLY DISINTEGRATING;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET, 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

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vardenafil hydrochloride

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	214031-004	Aug 4, 2020	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
Zydus Pharms	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	208960-002	Oct 31, 2018	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for vardenafil hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1858490	FORMES PHARMACEUTIQUES A PROPRIETES PHARMACOCINETIQUES AMELIOREES (PHARMACEUTICAL FORMS WITH IMPROVED PHARMACOKINETIC PROPERTIES)	⤷ Sign Up
Guatemala	200600097	FORMAS FARMACEUTICAS CON PROPIEDADES FARMACOCINETICAS MEJORADAS	⤷ Sign Up
New Zealand	561004	Pharmaceutical forms comprising vardenafil with improved pharmacokinetic properties	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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