Pepcid Ac is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is protected by 6 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 Ac'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). | |||
| US5667794 | Heartburn treatment |
May, 2015
(9 years ago) |
Expired
|
|
US5667794 (Pediatric) | Heartburn treatment |
Nov, 2015
(8 years ago) |
Expired
|
| US5854267 | Method for preventing heartburn |
Dec, 2015
(8 years ago) |
Expired
|
|
US5854267 (Pediatric) | Method for preventing heartburn |
Jun, 2016
(8 years ago) |
Expired
|
| US6814978 | Process for preparing a soft tablet |
Aug, 2021
(2 years ago) |
Expired
|
|
US6814978 (Pediatric) | Process for preparing a soft tablet |
Feb, 2022
(2 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Pepcid Ac 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 Ac's family patents as well as insights into ongoing legal events on those patents.
Pepcid Ac's family patents
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Generic Launch
Generic Release Date:
Pepcid Ac'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 Ac Generics:
Famotidine is the generic name for the brand Pepcid Ac. 51 different companies have already filed for the generic of Pepcid Ac, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pepcid Ac's generic
How can I launch a generic of Pepcid Ac before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pepcid Ac's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pepcid Ac'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 Ac -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg (OTC) |
About Pepcid Ac
Pepcid Ac is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is used for preventing heartburn episodes caused by consuming heartburn-inducing food or beverages. Pepcid Ac uses Famotidine as an active ingredient. Pepcid Ac was launched by J And J Consumer Inc in 1998.
Market Authorisation Date:
Pepcid Ac was approved by FDA for market use on 24 September, 1998.
Active Ingredient:
Pepcid Ac uses Famotidine as the active ingredient. Check out other Drugs and Companies using Famotidine ingredient
Treatment:
Pepcid Ac is used for preventing heartburn episodes caused by consuming heartburn-inducing food or beverages.
Dosage:
Pepcid Ac is available in the following dosage forms - tablet, chewable form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE | Discontinued | ORAL |
| 10MG | TABLET | Over the counter | ORAL |
| 20MG | TABLET, CHEWABLE | Over the counter | ORAL |