Pepcid Complete is a drug owned by Kenvue Brands Llc. It is protected by 5 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 Feb 26, 2022. Details of Pepcid Complete'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). | |||
|
US6814978 (Pediatric) | Process for preparing a soft tablet |
Feb, 2022
(3 years ago) |
Expired
|
| US6814978 | Process for preparing a soft tablet |
Aug, 2021
(3 years ago) |
Expired
|
|
US5989588 (Pediatric) | Methods and compositions for preventing and treating heartburn |
Mar, 2016
(9 years ago) |
Expired
|
| US5989588 | Methods and compositions for preventing and treating heartburn |
Sep, 2015
(9 years ago) |
Expired
|
|
US5229137 (Pediatric) | Methods and pharmaceutical compositions for treating episodic heartburn |
Nov, 2012
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Pepcid Complete 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 Pepcid Complete's family patents as well as insights into ongoing legal events on those patents.
Pepcid Complete's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pepcid Complete's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 26, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pepcid Complete Generic API suppliers:
Calcium Carbonate; Famotidine; Magnesium Hydroxide is the generic name for the brand Pepcid Complete. 1 company has already filed for the generic of Pepcid Complete. Check out the entire list of companies who have already received approval for Pepcid Complete's generic
How can I launch a generic of Pepcid Complete before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pepcid Complete's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pepcid Complete'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 Pepcid Complete -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 800 mg/10 mg/ 165 mg (OTC) | 01 Nov, 2004 | 1 | 06 Feb, 2008 | 30 Mar, 2016 | Deferred |
About Pepcid Complete
Pepcid Complete is a drug owned by Kenvue Brands Llc. It is used for treatment of various conditions. Pepcid Complete uses Calcium Carbonate; Famotidine; Magnesium Hydroxide as an active ingredient. Pepcid Complete was launched by Kenvue Brands in 2000.
Approval Date:
Pepcid Complete was approved by FDA for market use on 16 October, 2000.
Active Ingredient:
Pepcid Complete uses Calcium Carbonate; Famotidine; Magnesium Hydroxide as the active ingredient. Check out other Drugs and Companies using Calcium Carbonate; Famotidine; Magnesium Hydroxide ingredient
Treatment:
Pepcid Complete is used for treatment of various conditions.
Dosage:
Pepcid Complete is available in tablet, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 800MG;10MG;165MG | TABLET, CHEWABLE | Over the counter | ORAL |