LEVITRA Drug Patent Profile

✉ Email this page to a colleague

Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levitra

A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3^rd, 2012.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for LEVITRA?
What are the global sales for LEVITRA?
What is Average Wholesale Price for LEVITRA?

Summary for LEVITRA

International Patents:	54
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	26
Patent Applications:	4,858
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
What excipients (inactive ingredients) are in LEVITRA?	LEVITRA excipients list
DailyMed Link:	LEVITRA at DailyMed

Drug patent expirations by year for LEVITRA

Recent Clinical Trials for LEVITRA

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

Sponsor	Phase
Respira Therapeutics, Inc.	Phase 1
Tritech Biopharmaceuticals Co., Ltd.	Phase 1/Phase 2
A2 Healthcare Taiwan Corporation	Phase 1/Phase 2

See all LEVITRA clinical trials

Paragraph IV (Patent) Challenges for LEVITRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 LEVITRA

LEVITRA is protected by one US patents.

Patents protecting LEVITRA

Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003		DISCN	Yes	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 LEVITRA

Subscribe to access the full database, or Sign Up
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	021400-003	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	021400-001	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 LEVITRA

See the table below for patents covering LEVITRA around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Peru	131799	IMIDAZOTRIAZINONAS SUSTITUIDAS POR 2-FENILO	⤷ Sign Up
Croatia	P20050143	MEDICAMENTS CONTAINING VARDENAFIL HYDROCHLORIDE TRIHYDRATE	⤷ Sign Up
Morocco	27320	MEDICAMENT CONTENANT DU TRIHYDRATE D'HYDROCHLORURE DE VARDENFIL	⤷ Sign Up
Portugal	1049695		⤷ Sign Up
Malaysia	138535	2-PHENYL-SUBSTITUTED IMIDAZOTRIAZINONES AS PHOSPHODIESTERASE INHIBITORS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration