TOLCAPONE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Tolcapone, and what generic alternatives are available?
Tolcapone is a drug marketed by Alvogen, Dr Reddys Labs Sa, Endo Operations, and Novast Labs. 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 NOVAST LABS on August 7th, 2018.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TOLCAPONE?
- What are the global sales for TOLCAPONE?
- What is Average Wholesale Price for TOLCAPONE?
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: | 5,522 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novast Labs | TOLCAPONE | tolcapone | TABLET;ORAL | 208937-001 | Aug 7, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | TOLCAPONE | tolcapone | TABLET;ORAL | 210095-001 | Aug 1, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | TOLCAPONE | tolcapone | TABLET;ORAL | 204584-001 | Mar 26, 2015 | DISCN | 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 |
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 |
