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, Endo Operations, Glenmark Pharms Ltd, Lupin Ltd, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Strides Pharma, Teva, Twi Pharms, Watson Labs, Zydus Pharms Usa Inc, 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-three NDAs.
The generic ingredient in TOPIRAMATE is topiramate. There are twenty-six drug master file entries for this compound. Fifty-four 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.
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Questions you can ask:
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Summary for TOPIRAMATE
| US Patents: | 0 |
| Applicants: | 35 |
| NDAs: | 43 |
| Finished Product Suppliers / Packagers: | 50 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 293 |
| Patent Applications: | 5,077 |
| 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 |
See drug prices 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ascent Pharms Inc | TOPIRAMATE | topiramate | TABLET;ORAL | 215414-001 | Aug 26, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Invagen Pharms | TOPIRAMATE | topiramate | TABLET;ORAL | 079162-003 | Mar 27, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | TOPIRAMATE | topiramate | CAPSULE;ORAL | 218482-002 | Jun 13, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus | TOPIRAMATE | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 207382-002 | Nov 24, 2017 | AB1 | 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 |
