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
|
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
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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 Generic API suppliers:
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 |