Suprax is a drug owned by Lupin Ltd. It is protected by 1 US drug patent filed in 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 14, 2028. Details of Suprax'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). | |||
| US9233112 | Pharmaceutical compositions of cefixime |
Dec, 2028
(4 years from now) | Active |
US patents provide insights into the exclusivity only within the United States, but Suprax 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 Suprax's family patents as well as insights into ongoing legal events on those patents.
Suprax's family patents
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Generic Launch
Generic Release Date:
Suprax's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 14, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Suprax Generics:
Cefixime is the generic name for the brand Suprax. 6 different companies have already filed for the generic of Suprax, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Suprax's generic
How can I launch a generic of Suprax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Suprax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Suprax'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 Suprax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/5 mL | 22 Jul, 2016 | 1 | 06 Feb, 2017 | 14 Dec, 2028 | Deferred |
About Suprax
Suprax is a drug owned by Lupin Ltd. It is used for treating bacterial infections. Suprax uses Cefixime as an active ingredient. Suprax was launched by Lupin Ltd in 2013.
Market Authorisation Date:
Suprax was approved by FDA for market use on 20 February, 2013.
Active Ingredient:
Suprax uses Cefixime as the active ingredient. Check out other Drugs and Companies using Cefixime ingredient
Treatment:
Suprax is used for treating bacterial infections.
Dosage:
Suprax is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/5ML | FOR SUSPENSION | Prescription | ORAL |