TOPIRAMATE Drug Patent Profile
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Which patents cover Topiramate, and when can generic versions of Topiramate launch?
Topiramate is a drug marketed by Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, Par Pharm, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Fosun Pharma, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Totowa, Ascent Pharms Inc, Aurobindo Pharma, Chartwell, Cipla Ltd, Glenmark Generics, Hikma Pharms, Invagen Pharms, Mylan, Pliva Hrvatska Doo, Roxane, Sun Pharm, Sun Pharm Inds Ltd, Torrent Pharms, Unichem Labs Ltd, Upsher Smith Labs, Viwit Pharm, and Wockhardt. and is included in forty NDAs.
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the topiramate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Topiramate
A generic version of TOPIRAMATE was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.
Summary for TOPIRAMATE
US Patents: | 0 |
Applicants: | 35 |
NDAs: | 40 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 290 |
Patent Applications: | 5,419 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
Recent Clinical Trials for TOPIRAMATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AbbVie | Phase 3 |
Radboud University Medical Center | Phase 2 |
Eurofarma Laboratorios S.A. | Phase 3 |
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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell | TOPIRAMATE | topiramate | TABLET;ORAL | 078410-002 | Sep 11, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roxane | TOPIRAMATE | topiramate | TABLET;ORAL | 076306-003 | Mar 27, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fosun Pharma | TOPIRAMATE | topiramate | CAPSULE;ORAL | 079206-002 | Oct 14, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zydus | TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 208949-004 | Nov 29, 2022 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma Pharms | TOPIRAMATE | topiramate | TABLET;ORAL | 091185-004 | Nov 25, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |