Levitra Patent Expiration

Levitra is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 23, 2027. Details of Levitra's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7696206 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Oct, 2018

(5 years ago)

Expired
US6362178 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
Oct, 2018

(5 years ago)

Expired
US8841446 Medicaments containing vardenafil hydrochloride trihydrate
Jul, 2023

(1 year, 16 days ago)

Expired
US8273876 Medicaments containing vardenafil hydrochloride trihydrate
Jul, 2027

(3 years from now)

Active

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Several oppositions have been filed on Levitra's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Levitra's generic, the next section provides detailed information on ongoing and past EP oppositions related to Levitra patents.

Levitra's oppositions filed in EPO

Levitra has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 27, 2012, by Zentiva K.S.. This opposition was filed on patent number EP03763695A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP10183693A Jul, 2017 Accord Healthcare Ltd Opposition rejected
EP10183693A Jul, 2017 Teva Pharmaceutical Industries Ltd Opposition rejected
EP10183693A Jul, 2017 Zentiva k.s. Opposition rejected
EP03763695A Sep, 2012 Accord Healthcare Ltd Revoked
EP03763695A Sep, 2012 Zentiva k.s. Revoked


US patents provide insights into the exclusivity only within the United States, but Levitra is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Levitra's family patents as well as insights into ongoing legal events on those patents.

Levitra's family patents

Levitra has patent protection in a total of 31 countries. It's US patent count contributes only to 4.3% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Levitra.

Family Patents

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Generic Launch

Generic Release Date:

Levitra's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 23, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Levitra Generics:

Vardenafil Hydrochloride is the generic name for the brand Levitra. 7 different companies have already filed for the generic of Levitra, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Levitra's generic

How can I launch a generic of Levitra before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Levitra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Levitra's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Levitra -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2.5 mg 04 Sep, 2009 1 03 May, 2012 31 Oct, 2018 Deferred
5 mg and 10 mg 10 Jul, 2009 1 03 May, 2012 31 Oct, 2018 Deferred
20 mg 05 Mar, 2009 1 03 May, 2012 31 Oct, 2018 Deferred




About Levitra

Levitra is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating erectile dysfunction. Levitra uses Vardenafil Hydrochloride as an active ingredient. Levitra was launched by Bayer Hlthcare in 2003.

Market Authorisation Date:

Levitra was approved by FDA for market use on 19 August, 2003.

Active Ingredient:

Levitra uses Vardenafil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Vardenafil Hydrochloride ingredient

Treatment:

Levitra is used for treating erectile dysfunction.

Dosage:

Levitra is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL