Topamax Patent Expiration

Topamax is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 10 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 Sep 01, 2019. Details of Topamax'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).
US7125560

(Pediatric)

Pharmaceutical composition of topiramate
Sep, 2019

(5 years ago)

Expired
US7125560 Pharmaceutical composition of topiramate
Mar, 2019

(5 years ago)

Expired
US5998380

(Pediatric)

Treatment of migraine
Apr, 2016

(8 years ago)

Expired
US7018983

(Pediatric)

Treatment of migraine
Apr, 2016

(8 years ago)

Expired
US6503884

(Pediatric)

Migraine treatment method using topiramate and related compounds
Apr, 2016

(8 years ago)

Expired
US7498311

(Pediatric)

Treatment of migraine
Apr, 2016

(8 years ago)

Expired
US7018983 Treatment of migraine
Oct, 2015

(9 years ago)

Expired
US7498311 Treatment of migraine
Oct, 2015

(9 years ago)

Expired
US5998380 Treatment of migraine
Oct, 2015

(9 years ago)

Expired
US6503884 Migraine treatment method using topiramate and related compounds
Oct, 2015

(9 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 Topamax's patents.

Given below is the list of recent legal activities going on the following patents of Topamax.

Activity Date Patent Number
Patent litigations
Expire Patent 23 Apr, 2018 US7018983
Payment of Maintenance Fee, 12th Year, Large Entity 12 Apr, 2018 US7125560
Maintenance Fee Reminder Mailed 06 Nov, 2017 US7018983
Expire Patent 31 Mar, 2017 US7498311
Recordation of Patent Grant Mailed 03 Mar, 2009 US7498311
Patent Issue Date Used in PTA Calculation 03 Mar, 2009 US7498311
Email Notification 12 Feb, 2009 US7498311
Issue Notification Mailed 11 Feb, 2009 US7498311
Dispatch to FDC 30 Jan, 2009 US7498311
Mail Response to 312 Amendment (PTO-271) 28 Jan, 2009 US7498311


FDA has granted several exclusivities to Topamax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Topamax, 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 Topamax.

Exclusivity Information

Topamax holds 3 exclusivities. All of its exclusivities have expired in 2017. Details of Topamax's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-54) Dec 22, 2012
Pediatric Exclusivity(PED) Jun 22, 2013
New Patient Population(NPP) Mar 28, 2017

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Topamax 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 Topamax's family patents as well as insights into ongoing legal events on those patents.

Topamax's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Topamax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 01, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Topamax Generic API suppliers:

Topiramate is the generic name for the brand Topamax. 37 different companies have already filed for the generic of Topamax, with Glenmark Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Topamax's generic

How can I launch a generic of Topamax before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Topamax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Topamax'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 Topamax -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
15 mg and 25 mg 07 Sep, 2005 1 15 Apr, 2009 01 Sep, 2019 Eligible
25 mg, 100 mg and 200 mg 26 Dec, 2001
50 mg 08 Sep, 2005 1 27 Mar, 2009 26 Sep, 2008 Extinguished

Alternative Brands for Topamax

Topamax which is used for preventing migraines and treating seizures., has several other brand drugs in the same treatment category and using the same active ingredient (Topiramate). 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 Treatment Area
Janssen Pharms
Topamax Sprinkle

(uses Topiramate)

Used for preventing migraines and treating seizures.
Upsher Smith Labs
Qudexy Xr

(uses Topiramate)

Used for managing and controlling seizures.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Topiramate. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Azurity
Eprontia
Supernus Pharms
Trokendi Xr
Vivus Llc
Qsymia


Apart from brand drugs containing the same ingredient, some generics have also been filed for Topiramate, Topamax's active ingredient. Check the complete list of approved generic manufacturers for Topamax





About Topamax

Topamax is a drug owned by Janssen Pharmaceuticals Inc. It is used for preventing migraines and treating seizures. Topamax uses Topiramate as an active ingredient. Topamax was launched by Janssen Pharms in 1998.

Approval Date:

Topamax was approved by FDA for market use on 26 October, 1998.

Active Ingredient:

Topamax uses Topiramate as the active ingredient. Check out other Drugs and Companies using Topiramate ingredient

Treatment:

Topamax is used for preventing migraines and treating seizures.

Dosage:

Topamax is available in the following dosage forms - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
15MG CAPSULE Prescription ORAL
25MG CAPSULE Prescription ORAL
400MG TABLET Discontinued ORAL
50MG TABLET Prescription ORAL
200MG TABLET Prescription ORAL
300MG TABLET Discontinued ORAL
100MG TABLET Prescription ORAL