Singulair Patent Expiration

Singulair is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 24, 2022. Details of Singulair'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).
US5565473

(Pediatric)

Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists
Aug, 2012

(11 years ago)

Expired
US8007830 Granule formation
Oct, 2022

(1 year, 8 months ago)

Expired


FDA has granted several exclusivities to Singulair. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Singulair, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Singulair.

Exclusivity Information

Singulair holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Singulair's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Mar 26, 2015

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Several oppositions have been filed on Singulair'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 Singulair's generic, the next section provides detailed information on ongoing and past EP oppositions related to Singulair patents.

Singulair's oppositions filed in EPO

Singulair has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 05, 2008, by Hexal Ag. This opposition was filed on patent number EP02801836A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP02801836A Nov, 2008 Hexal AG Revoked


US patents provide insights into the exclusivity only within the United States, but Singulair 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 Singulair's family patents as well as insights into ongoing legal events on those patents.

Singulair's family patents

Singulair has patent protection in a total of 24 countries. It's US patent count contributes only to 11.1% of its total global patent coverage. 21 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 Singulair.

Family Patents

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Generic Launch

Generic Release Date:

Singulair's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 24, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Singulair Generics:

Montelukast Sodium is the generic name for the brand Singulair. 28 different companies have already filed for the generic of Singulair, with Mylan Pharms Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Singulair's generic

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

You can seek FDA approval to launch a generic drug before the expiration of Singulair's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Singulair'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 Singulair -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg 20 Feb, 2007 2 03 Aug, 2012 03 Feb, 2012 Extinguished
4 mg and 5 mg 26 Dec, 2006 1 03 Aug, 2012 03 Aug, 2012 Extinguished
4 mg 17 Oct, 2008 1 03 Aug, 2012 03 Aug, 2012 Extinguished




About Singulair

Singulair is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for treating Asthma. Singulair uses Montelukast Sodium as an active ingredient. Singulair was launched by Organon in 2000.

Market Authorisation Date:

Singulair was approved by FDA for market use on 03 March, 2000.

Active Ingredient:

Singulair uses Montelukast Sodium as the active ingredient. Check out other Drugs and Companies using Montelukast Sodium ingredient

Treatment:

Singulair is used for treating Asthma.

Dosage:

Singulair is available in the following dosage forms - tablet form for oral use, granule form for oral use, tablet, chewable form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 5MG BASE TABLET, CHEWABLE Prescription ORAL
EQ 10MG BASE TABLET Prescription ORAL
EQ 4MG BASE TABLET, CHEWABLE Prescription ORAL
EQ 4MG BASE/PACKET GRANULE Prescription ORAL