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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 23 Apr, 2018 | US7018983 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2018 | US7125560 |
| Maintenance Fee Reminder Mailed Critical | 06 Nov, 2017 | US7018983 |
| Expire Patent Critical | 31 Mar, 2017 | US7498311 |
| Recordation of Patent Grant Mailed Critical | 03 Mar, 2009 | US7498311 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Mar, 2009 | US7498311 |
| Email Notification Critical | 12 Feb, 2009 | US7498311 |
| Issue Notification Mailed Critical | 11 Feb, 2009 | US7498311 |
| Dispatch to FDC | 30 Jan, 2009 | US7498311 |
| Mail Response to 312 Amendment (PTO-271) Critical | 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
| Upsher Smith Labs |
| |||
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 |
| |
| Supernus Pharms |
| |
| Vivus Llc |
|
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 - tablet form for oral use, capsule 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 |