Prevacid is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 12 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 17, 2019. Details of Prevacid'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). | |||
|
US6328994 (Pediatric) | Orally disintegrable tablets |
Nov, 2019
(5 years ago) |
Expired
|
|
US7875292 (Pediatric) | Orally disintegrable tablets |
Nov, 2019
(5 years ago) |
Expired
|
|
US9901546 (Pediatric) | Orally disintegrable tablets |
Nov, 2019
(5 years ago) |
Expired
|
|
US7431942 (Pediatric) | Orally disintegrable tablets |
Nov, 2019
(5 years ago) |
Expired
|
| US9901546 | Orally disintegrable tablets |
May, 2019
(6 years ago) |
Expired
|
| US6328994 | Orally disintegrable tablets |
May, 2019
(6 years ago) |
Expired
|
| US7431942 | Orally disintegrable tablets |
May, 2019
(6 years ago) |
Expired
|
| US7875292 | Orally disintegrable tablets |
May, 2019
(6 years ago) |
Expired
|
|
US7399485 (Pediatric) | Rapidly Disintegrable solid preparation |
Nov, 2018
(6 years ago) |
Expired
|
| US7399485 | Rapidly Disintegrable solid preparation |
May, 2018
(7 years ago) |
Expired
|
|
US5464632 (Pediatric) | Rapidly disintegratable multiparticular tablet |
May, 2013
(12 years ago) |
Expired
|
| US5464632 | Rapidly disintegratable multiparticular tablet |
Nov, 2012
(13 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Prevacid's patents.
Latest Legal Activities on Prevacid's Patents
Given below is the list of recent legal activities going on the following patents of Prevacid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 27 Feb, 2023 | US7875292 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 12 Sep, 2022 | US7875292 (Litigated) |
| Expire Patent
Critical | 04 Apr, 2022 | US9901546 |
| Maintenance Fee Reminder Mailed
Critical | 18 Oct, 2021 | US9901546 |
| Expire Patent
Critical | 09 Nov, 2020 | US7431942 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 25 May, 2020 | US7431942 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jul, 2018 | US7875292 (Litigated) |
| Post Issue Communication - Certificate of Correction | 15 Jun, 2018 | US9901546 |
| Recordation of Patent Grant Mailed
Critical | 27 Feb, 2018 | US9901546 |
| Patent Issue Date Used in PTA Calculation
Critical | 27 Feb, 2018 | US9901546 |
FDA has granted several exclusivities to Prevacid. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Prevacid, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Prevacid.
Exclusivity Information
Prevacid holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Prevacid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-85) | Oct 28, 2011 |
| Pediatric Exclusivity(PED) | Apr 28, 2012 |
US patents provide insights into the exclusivity only within the United States, but
Prevacid 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 Prevacid's family patents as well as insights into
ongoing legal events
on those patents.
Prevacid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prevacid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 17, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prevacid Generic API suppliers:
Lansoprazole is the generic name for the brand Prevacid. 27 different companies have already filed for the generic of Prevacid, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prevacid's generic
How can I launch a generic of Prevacid before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prevacid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prevacid'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 Prevacid -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg and 30 mg | 05 Dec, 2005 | ||||
| 15 mg and 30 mg | 27 Dec, 2006 | 1 | 15 Oct, 2010 | 10 May, 2009 | Extinguished |
Alternative Brands for Prevacid
There are several other brand drugs using the same active ingredient (Lansoprazole) as Prevacid. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Dexcel |
| ||
| Takeda Pharms Na |
| ||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lansoprazole, Prevacid's active ingredient. Check the complete list of approved generic manufacturers for Prevacid
About Prevacid
Prevacid is a drug owned by Takeda Pharmaceuticals Usa Inc. Prevacid uses Lansoprazole as an active ingredient. Prevacid was launched by Takeda Pharms Usa in 2002.
Approval Date:
Prevacid was approved by FDA for market use on 30 August, 2002.
Active Ingredient:
Prevacid uses Lansoprazole as the active ingredient. Check out other Drugs and Companies using Lansoprazole ingredient
Dosage:
Prevacid is available in tablet, orally disintegrating, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE | Prescription | ORAL |
| 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE | Prescription | ORAL |