TOLCAPONE Drug Patent Profile
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Which patents cover Tolcapone, and what generic alternatives are available?
Tolcapone is a drug marketed by Alvogen, Dr Reddys Labs Sa, Novast Labs, and Par Pharm Inc. and is included in four NDAs.
The generic ingredient in TOLCAPONE is tolcapone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolcapone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tolcapone
A generic version of TOLCAPONE was approved as tolcapone by PAR PHARM INC on March 26th, 2015.
Summary for TOLCAPONE
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 25 |
Patent Applications: | 5,157 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TOLCAPONE |
What excipients (inactive ingredients) are in TOLCAPONE? | TOLCAPONE excipients list |
DailyMed Link: | TOLCAPONE at DailyMed |
Recent Clinical Trials for TOLCAPONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Colorado, Denver | Phase 2 |
University of California, San Francisco | Early Phase 1 |
Lawrence Berkeley National Laboratory | Early Phase 1 |
Pharmacology for TOLCAPONE
Drug Class | Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TOLCAPONE
US Patents and Regulatory Information for TOLCAPONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alvogen | TOLCAPONE | tolcapone | TABLET;ORAL | 207729-001 | Jul 29, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Pharm Inc | TOLCAPONE | tolcapone | TABLET;ORAL | 204584-001 | Mar 26, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys Labs Sa | TOLCAPONE | tolcapone | TABLET;ORAL | 210095-001 | Aug 1, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novast Labs | TOLCAPONE | tolcapone | TABLET;ORAL | 208937-001 | Aug 7, 2018 | AB | RX | 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 |
EU/EMA Drug Approvals for TOLCAPONE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Viatris Healthcare Limited | Tasmar | tolcapone | EMEA/H/C/000132 Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors.Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar. |
Authorised | no | no | no | 1997-08-27 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |