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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8007830 | Granule formation |
Oct, 2022
(2 years ago) |
Expired
|
|
US5565473 (Pediatric) | Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists |
Aug, 2012
(12 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Singulair's patents.
Latest Legal Activities on Singulair's Patents
Given below is the list of recent legal activities going on the following patents of Singulair.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 02 Oct, 2023 | US8007830 |
| Maintenance Fee Reminder Mailed Critical | 19 Apr, 2023 | US8007830 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2019 | US8007830 |
| Recordation of Patent Grant Mailed Critical | 30 Aug, 2011 | US8007830 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Aug, 2011 | US8007830 |
| Issue Notification Mailed Critical | 10 Aug, 2011 | US8007830 |
| Application Is Considered Ready for Issue Critical | 26 Jul, 2011 | US8007830 |
| Dispatch to FDC | 26 Jul, 2011 | US8007830 |
| Issue Fee Payment Received Critical | 25 Jul, 2011 | US8007830 |
| Issue Fee Payment Verified Critical | 25 Jul, 2011 | US8007830 |
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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Montelukast Sodium is the generic name for the brand Singulair. 28 different companies have already filed for the generic of Singulair, with Aurobindo Pharma Ltd 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 2002.
Approval Date:
Singulair was approved by FDA for market use on 26 July, 2002.
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, tablet, chewable form for oral use, granule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE/PACKET | GRANULE | Prescription | ORAL |
| EQ 5MG BASE | TABLET, CHEWABLE | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |
| EQ 4MG BASE | TABLET, CHEWABLE | Prescription | ORAL |