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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Questions you can ask:
- What is the 5 year forecast for TOPAMAX?
- What are the global sales for TOPAMAX?
- What is Average Wholesale Price for TOPAMAX?
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 | |||
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-006 | Dec 24, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-002 | Oct 26, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-004 | Dec 24, 1996 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-002 | 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 | 020505-006 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-004 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-004 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | TABLET;ORAL | 020505-003 | Dec 24, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | TOPAMAX | topiramate | CAPSULE;ORAL | 020844-002 | Oct 26, 1998 | ⤷ 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 | 020505-001 | 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 |
---|---|---|---|
Denmark | 173923 | ⤷ Sign Up | |
Israel | 138032 | PHARMACEUTICAL COMPOSITION OF TOPIRAMATE | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 9713510 | ⤷ Sign Up | |
Taiwan | 590778 | ⤷ Sign Up | |
Australia | 7443496 | ⤷ Sign Up | |
Bulgaria | 104727 | ⤷ Sign Up | |
Argentina | 017984 | PROCESO PARA FORMAR UNA COMPOSICION FARMACEUTICA DE TOPIRAMATO Y COMPOSICION FARMACEUTICA DE TOPIRAMATO | ⤷ 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 |