Is there a generic for Topiramate?

Yes. The FDA Orange Book lists 53 approved generic (ANDA) applications for Topiramate, referencing the brand EPRONTIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Topiramate?

EPRONTIA (NDA 214679, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Topiramate?

The Orange Book lists 20 patents against Topiramate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Topiramate have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Topiramate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Topiramate are approved?

Topiramate is approved in the following dosage forms: capsule, capsule, extended release, solution, tablet.

FDA Orange Book · active-ingredient family

Topiramate

Topiramate: 5 brands, 53 generics; first approved Dec 24, 1996; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 53 ANDA applications approved.

Earliest patent expiry Nov 16, 2027Latest exclusivity ends Feb 01, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 16, 2027

in 1 yr 2 mo

Brand (NDA) products

Originator applications

EPRONTIARLDRS
AZURITYNDA 2146792021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML SOLUTION ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SOLUTION	ORAL	Rx	AB

QUDEXY XRRLD

UPSHER SMITH LABSNDA 20512220145 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TROKENDI XRRLD

SUPERNUS PHARMSNDA 20163520134 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPAMAXRLD
JANSSEN PHARMSNDA 02084419983 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
50MG CAPSULE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB
50MG	CAPSULE	ORAL	Discontinued	—

TOPAMAXRLD

JANSSEN PHARMSNDA 02050519966 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Discontinued	—
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (53)

Abbreviated applications

TOPIRAMATE

MICRO LABSANDA 21918320264 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

BIOCON PHARMAANDA 22094320264 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

RICONPHARMA LLCANDA 22004120265 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

TOPIRAMATE

ASCENT PHARMS INCANDA 21744320264 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

AJANTA PHARMA LTDANDA 21956420255 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TOPIRAMATE
RUBICON RESEARCHANDA 21668320253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
50MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB
50MG	CAPSULE	ORAL	Rx	AB

TOPIRAMATE

AMTAANDA 21869520245 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TOPIRAMATE

XIAMEN LP PHARM COANDA 21563820245 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TOPIRAMATE
ALKEM LABS LTDANDA 2177952024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/ML SOLUTION ORAL Rx AB
TOPIRAMATE
SENORES PHARMSANDA 21864220242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
TOPIRAMATE
GLENMARK PHARMS LTDANDA 21786920242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML	SOLUTION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB

TOPIRAMATE

LUPINANDA 21556120244 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE
ALKEM LABS LTDANDA 21848220242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
TOPIRAMATE
TWI PHARMSANDA 21769420232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB

TOPIRAMATE

DR REDDYSANDA 21723120234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE
AUROBINDO PHARMA LTDANDA 21544920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB

TOPIRAMATE

AJANTA PHARMA LTDANDA 21566320234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

ALKEM LABS LTDANDA 21724820234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

PH HEALTHANDA 20597620234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE

ACTAVIS LABS FLANDA 20621020234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE
ZYDUS PHARMSANDA 2161672023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG CAPSULE, EXTENDED RELEASE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

TOPIRAMATE

ZYDUSANDA 20894920225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TOPIRAMATE
ASCENT PHARMS INCANDA 21541420214 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

TOPIRAMATE

GLENMARK PHARMS LTDANDA 21027820215 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
150MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

TOPIRAMATE

ZYDUSANDA 20738220174 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
200MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

TOPIRAMATE
HIKMA PHARMSANDA 09118520134 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
CHARTWELLANDA 07841020134 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
ACTAVIS TOTOWAANDA 07863720134 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
SENORES PHARMSANDA 09035320104 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
AIPING PHARM INCANDA 07849920104 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
CHARTWELL RXANDA 07920620092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
TOPIRAMATE
STRIDES PHARMAANDA 07841820093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
50MG CAPSULE ORAL Rx AB
TOPIRAMATE
ZYDUS PHARMS USA INCANDA 07887720093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Rx AB
25MG CAPSULE ORAL Rx AB
50MG CAPSULE ORAL Rx AB
TOPIRAMATE
TEVAANDA 07657520092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
TOPIRAMATE
BARRANDA 07644820092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
TOPIRAMATE
WATSON LABSANDA 07786820092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
TOPIRAMATE
PLIVA HRVATSKA DOOANDA 07790520094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
ACCORD HLTHCAREANDA 07631120094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
AUROBINDO PHARMAANDA 07846220094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
BARRANDA 07631520093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
CIPLA LTDANDA 07634320094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
GLENMARK PHARMS LTDANDA 07762720094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
INVAGEN PHARMSANDA 07916220094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
NATCOANDA 07631420094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
PHARMACOANDA 07773320094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
ROXANEANDA 07630620094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
SUN PHARMANDA 09027820094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Discontinued —
TOPIRAMATE
SUN PHARM INDS LTDANDA 07632720093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
TEVAANDA 07631720094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
TORRENT PHARMSANDA 07915320094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
UNICHEM LABS LTDANDA 09016220094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB
TOPIRAMATE
WATSON LABSANDA 07764320094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
50MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
200MG TABLET ORAL Discontinued —
TOPIRAMATE
ZYDUS PHARMS USA INCANDA 07823520094 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
50MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
200MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB
50MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Rx	AB
25MG	CAPSULE	ORAL	Rx	AB
50MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
50MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
50MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

CGTFDA marketing exclusivity
Feb 01, 2026
8 mo ago
PCPatent-challenge (180-day generic) exclusivity
Jan 05, 2026
9 mo ago

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8663683	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
8992989	Nov 16, 2027	in 1 yr 2 mo	ProductU-1675
8889191	Nov 16, 2027	in 1 yr 2 mo	U-106
9549940	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
8298580	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
8877248	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
9555004	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
10314790	Nov 16, 2027	in 1 yr 2 mo	ProductU-1675
9622983	Nov 16, 2027	in 1 yr 2 mo	ProductU-1992
8298576	Apr 04, 2028	in 1 yr 7 mo	ProductU-106
10363224	Mar 19, 2033	in 6 yr 7 mo	U-766
9101545	Mar 19, 2033	in 6 yr 7 mo	Product
9555005	Mar 19, 2033	in 6 yr 7 mo	Product
8652527	Mar 19, 2033	in 6 yr 7 mo	Product
8889190	Mar 19, 2033	in 6 yr 7 mo	Product
11433046	Aug 21, 2040	in 14 yr 1 mo	U-3413
12290503	Aug 21, 2040	in 14 yr 1 mo	ProductU-3413
11911362	Aug 21, 2040	in 14 yr 1 mo	ProductU-3413
11826343	Aug 21, 2040	in 14 yr 1 mo	Product
11633374	Aug 21, 2040	in 14 yr 1 mo	Product

Approval history

FDA approval span

First approval

Dec 24, 1996

30 yr 2 mo ago

Most recent approval

Sep 04, 2026

18 d ago

Approvals span 1996–2026 across 58 FDA applications.

Brand (NDA) 59%

Generic (ANDA) 5391%

Topiramate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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