TOPIRAMATE - Generic Drug Details

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What are the generic drug sources for topiramate and what is the scope of patent protection?

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 five 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

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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
Chartwell Rx	TOPIRAMATE	topiramate	CAPSULE;ORAL	079206-001	Oct 14, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	TOPIRAMATE	topiramate	TABLET;ORAL	090278-004	Mar 27, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	TOPAMAX	topiramate	TABLET;ORAL	020505-003	Dec 24, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva Hrvatska Doo	TOPIRAMATE	topiramate	TABLET;ORAL	077905-001	Mar 30, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva Hrvatska Doo	TOPIRAMATE	topiramate	TABLET;ORAL	077905-003	Mar 30, 2009		DISCN	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
>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
Spain	2312308		⤷ Sign Up
European Patent Office	1973528	FORMULATIONS DE TOPIRAMATE À LIBÉRATION PROLONGÉE (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE)	⤷ Sign Up
European Patent Office	2394643	Formulations à libération prolongée de topiramate (Sustained-release formulations of topiramate)	⤷ Sign Up
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)	⤷ Sign Up
Canada	2618240	FORMULATIONS DE TOPIRAMATE A LIBERATION PROLONGEE (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE)	⤷ 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
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
0138441	SPC/GB95/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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