Topiramate - Generic Drug Details

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

Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Zydus, Zydus Pharms, Supernus Pharms, Janssen Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Azurity, Accord Hlthcare, Actavis Totowa, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Hikma Pharms, Invagen Pharms, Natco, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Viwit Pharm, and Wockhardt, and is included in forty-eight NDAs. There are nineteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Topiramate has twenty-one patent family members in eleven countries.

There are twenty-six drug master file entries for topiramate. Fifty-four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for topiramate

International Patents:	21
US Patents:	19
Tradenames:	6
Applicants:	39
NDAs:	48
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	293
Patent Applications:	7,416
Drug Prices:	Drug price trends for topiramate
Drug Sales Revenues:	Drug sales revenues for topiramate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for topiramate
What excipients (inactive ingredients) are in topiramate?	topiramate excipients list
DailyMed Link:	topiramate at DailyMed

See drug prices for topiramate

Drug Sales Revenue Trends for topiramate

See drug sales revenues for topiramate

Recent Clinical Trials for topiramate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shalamar Institute of Health Sciences	N/A
AbbVie	Phase 3
Henan Cancer Hospital	Phase 2

See all topiramate clinical trials

Generic filers with tentative approvals for TOPIRAMATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for topiramate

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for topiramate

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TOPIRAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPRONTIA	Oral Solution	topiramate	25 mg/mL	214679	1	2022-10-06
QUDEXY XR	Extended-release Capsules	topiramate	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg	205122	1	2015-12-24
TROKENDI XR	Extended-release Capsules	topiramate	25 mg, 50 mg, and 100 mg	201635	1	2014-05-12
TROKENDI XR	Extended-release Capsules	topiramate	200 mg	201635	1	2014-04-03
TOPAMAX	Tablets	topiramate	50 mg	020505	1	2005-09-08
TOPAMAX SPRINKLE	Capsules	topiramate	15 mg and 25 mg	020844	1	2005-09-07
TOPAMAX	Tablets	topiramate	25 mg, 100 mg and 200 mg	020505		2001-12-26

US Patents and Regulatory Information for topiramate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679-001	Nov 5, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Aiping Pharm Inc	TOPIRAMATE	topiramate	TABLET;ORAL	078499-002	Jan 7, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-001	Dec 24, 1996	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla Ltd	TOPIRAMATE	topiramate	TABLET;ORAL	076343-002	Mar 27, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	TOPIRAMATE	topiramate	TABLET;ORAL	215414-001	Aug 26, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	TOPIRAMATE	topiramate	CAPSULE;ORAL	215449-002	Sep 27, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for topiramate

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

International Patents for topiramate

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Country	Patent Number	Title	Estimated Expiration
Japan	2010510241		⤷ Sign Up
Israel	241053	קפסולות של טופיראמאט עם שחרור מושהה (Extended-release topiramate capsules)	⤷ Sign Up
Spain	2555066		⤷ Sign Up
Mexico	2009001711	FORMULACIONES DE LIBERACION SOSTENIDA DE TOPIRAMATO. (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008061226		⤷ Sign Up
Australia	2007319141	Sustained-release formulations of topiramate	⤷ Sign Up
South Korea	20150132838	서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for topiramate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138441	SPC/GB95/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
2317997	2190050-1	Sweden	⤷ Sign Up	PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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