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 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 |
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 |
Generic filers with tentative approvals for TOPIRAMATE
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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| >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
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOPIRAMATE
Supplementary Protection Certificates for TOPIRAMATE
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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