Delsym Patent Expiration

Delsym is a drug owned by Rb Health Us Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 16, 2017. Details of Delsym'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).
US5980882 Drug-resin complexes stabilized by chelating agents
Apr, 2017

(7 years ago)

Expired

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Delsym's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Delsym's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 16, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Delsym Generics:

Dextromethorphan Polistirex is the generic name for the brand Delsym. 2 different companies have already filed for the generic of Delsym, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Delsym's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
30 mg/5 mL 12 Jan, 2009 1 25 May, 2012 16 Apr, 2017 Eligible





About Delsym

Delsym is a drug owned by Rb Health Us Llc. It is used for treating a variety of conditions such as depression, anxiety, and panic disorders. Delsym uses Dextromethorphan Polistirex as an active ingredient. Delsym was launched by Rb Hlth in 1982.

Approval Date:

Delsym was approved by FDA for market use on 08 October, 1982.

Active Ingredient:

Delsym uses Dextromethorphan Polistirex as the active ingredient. Check out other Drugs and Companies using Dextromethorphan Polistirex ingredient

Treatment:

Delsym is used for treating a variety of conditions such as depression, anxiety, and panic disorders.

Dosage:

Delsym is available in suspension, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE Over the counter ORAL