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Serving leading biopharmaceutical companies globally:

Colorcon
Farmers Insurance
AstraZeneca
Daiichi Sankyo
Fish and Richardson
US Department of Justice
Johnson and Johnson
McKesson
Cantor Fitzgerald
Dow

Generated: January 19, 2018

DrugPatentWatch Database Preview

Topiramate - Generic Drug Details

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What are the generic sources for topiramate and what is the scope of topiramate freedom to operate?

Topiramate
is the generic ingredient in five branded drugs marketed by Upsher-smith Labs, Supernus Pharms, Janssen Pharms, Barr, Mylan, Sandoz, Teva, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Apotex Inc, Aurobindo Pharma, Cipla Ltd, Glenmark Generics, Invagen Pharms, Lupin, Pliva Hrvatska Doo, Roxane, Sun Pharm Inds Ltd, Sun Pharma Global, Torrent Pharms, Unichem Labs Ltd, Wockhardt Usa, and Hikma Pharms, and is included in thirty-two NDAs. There are fourteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Topiramate has fifty-seven patent family members in thirty-three countries.

There are twenty-six drug master file entries for topiramate. Fifty-three suppliers are listed for this compound. There are three tentative approvals for this compound.
Tentative approvals for TOPIRAMATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe25MGTABLET;ORAL
➤ Subscribe➤ Subscribe200MGTABLET;ORAL
➤ Subscribe➤ Subscribe100MGTABLET;ORAL

US Patents and Regulatory Information for topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-004 Aug 16, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Supernus Pharms TROKENDI XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635-001 Aug 16, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharma Global TOPIRAMATE topiramate TABLET;ORAL 090278-002 Mar 27, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Upsher-smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apotex Inc TOPIRAMATE topiramate TABLET;ORAL 077733-002 Mar 27, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin TOPIRAMATE topiramate TABLET;ORAL 078410-004 Sep 11, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Roxane TOPIRAMATE topiramate TABLET;ORAL 076306-003 Mar 27, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Upsher-smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Accord Hlthcare TOPIRAMATE topiramate TABLET;ORAL 076311-001 Mar 27, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Upsher-smith Labs TOPIRAMATE topiramate TABLET;ORAL 078499-003 Jan 7, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for topiramate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-004 Dec 24, 1996 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-001 Oct 26, 1998 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX SPRINKLE topiramate CAPSULE;ORAL 020844-003 Oct 26, 1998 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-006 Dec 24, 1996 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate TABLET;ORAL 020505-002 Dec 24, 1996 ➤ Subscribe ➤ Subscribe
Janssen Pharms TOPAMAX topiramate CAPSULE;ORAL 020844-002 Oct 26, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for topiramate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,696,091 Pharmaceutical composition of topiramate ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for topiramate

Supplementary Protection Certificates for topiramate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/028 United Kingdom ➤ Subscribe PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cantor Fitzgerald
Chinese Patent Office
Johnson and Johnson
Chubb
Healthtrust
Daiichi Sankyo
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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