TOPAMAX Drug Patent Profile
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Which patents cover Topamax, and what generic alternatives are available?
Topamax is a drug marketed by Janssen Pharms and is included in two NDAs.
The generic ingredient in TOPAMAX 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 Topamax
A generic version of TOPAMAX was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.
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Summary for TOPAMAX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 86 |
| Patent Applications: | 5,077 |
| Drug Prices: | Drug price information for TOPAMAX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOPAMAX |
| What excipients (inactive ingredients) are in TOPAMAX? | TOPAMAX excipients list |
| DailyMed Link: | TOPAMAX at DailyMed |
Recent Clinical Trials for TOPAMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
| Stanford University | Early Phase 1 |
| Université de Sherbrooke | Phase 4 |
Pharmacology for TOPAMAX
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for TOPAMAX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TOPAMAX | Tablets | topiramate | 50 mg | 020505 | 1 | 2005-09-08 |
| TOPAMAX | Tablets | topiramate | 25 mg, 100 mg and 200 mg | 020505 | 2001-12-26 |
US Patents and Regulatory Information for TOPAMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-001 | Oct 26, 1998 | AB | RX | Yes | 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 | ||||
| Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-005 | Dec 24, 1996 | AB | RX | Yes | 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 TOPAMAX
| 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 | topiramate | CAPSULE;ORAL | 020844-001 | Oct 26, 1998 | ⤷ 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 TOPAMAX
See the table below for patents covering TOPAMAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2003530295 | ⤷ Sign Up | |
| South Korea | 920001775 | ⤷ Sign Up | |
| Norway | 170280 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOPAMAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0138441 | 97C0097 | Belgium | ⤷ Sign Up | PRODUCT NAME: TOPIRAMAAT; NAT. REGISTRATION NO/DATE: 1028 IS 71 F 3 19970616; FIRST REGISTRATION: GB PL/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 |
| 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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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.
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