ENTACAPONE Drug Patent Profile
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When do Entacapone patents expire, and when can generic versions of Entacapone launch?
Entacapone is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sun Pharm, Sunshine, and Wockhardt Bio Ag. and is included in eight NDAs.
The generic ingredient in ENTACAPONE is entacapone. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Entacapone
A generic version of ENTACAPONE was approved as entacapone by SUN PHARM on July 16th, 2012.
Summary for ENTACAPONE
US Patents: | 0 |
Applicants: | 8 |
NDAs: | 8 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Clinical Trials: | 41 |
Patent Applications: | 5,987 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ENTACAPONE |
What excipients (inactive ingredients) are in ENTACAPONE? | ENTACAPONE excipients list |
DailyMed Link: | ENTACAPONE at DailyMed |
Recent Clinical Trials for ENTACAPONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Xiangya Hospital of Central South University | Early Phase 1 |
Bial - Portela C S.A. | Phase 4 |
TFS Trial Form Support | Phase 1 |
Pharmacology for ENTACAPONE
Drug Class | Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ENTACAPONE
Paragraph IV (Patent) Challenges for ENTACAPONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COMTAN | Tablets | entacapone | 200 mg | 020796 | 1 | 2007-04-11 |
US Patents and Regulatory Information for ENTACAPONE
EU/EMA Drug Approvals for ENTACAPONE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Orion Corporation | Entacapone Orion | entacapone | EMEA/H/C/002440 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. |
Authorised | no | no | no | 2011-08-18 | |
Orion Corporation | Comtess | entacapone | EMEA/H/C/000170 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. |
Authorised | no | no | no | 1998-09-16 | |
Orion Corporation | Comtan | entacapone | EMEA/H/C/000171 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. |
Authorised | no | no | no | 1998-09-22 | |
Teva Pharma B.V. | Entacapone Teva | entacapone | EMEA/H/C/002075 Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. |
Authorised | yes | no | no | 2011-02-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |