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, Pharmobedient, 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. Fourteen 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.
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Questions you can ask:
- What is the 5 year forecast for ENTACAPONE?
- What are the global sales for ENTACAPONE?
- What is Average Wholesale Price for ENTACAPONE?
Summary for ENTACAPONE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 44 |
| Patent Applications: | 7,403 |
| 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 |
|---|---|
| University Hospital Tuebingen | PHASE3 |
| The Affiliated Hospital of Qingdao University | Phase 1 |
| Second Affiliated Hospital of Soochow University | PHASE4 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | ENTACAPONE | entacapone | TABLET;ORAL | 205792-001 | Aug 31, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sunshine | ENTACAPONE | entacapone | TABLET;ORAL | 206669-001 | Oct 3, 2018 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Macleods Pharms Ltd | ENTACAPONE | entacapone | TABLET;ORAL | 207210-001 | Jun 5, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Wockhardt Bio Ag | ENTACAPONE | entacapone | TABLET;ORAL | 078941-001 | Aug 16, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | ENTACAPONE | entacapone | TABLET;ORAL | 212601-001 | Jan 4, 2022 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma Ltd | ENTACAPONE | entacapone | TABLET;ORAL | 203437-001 | Jun 19, 2015 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 ENTACAPONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Orion Corporation | Entacapone Orion | entacapone | EMEA/H/C/002440Entacapone 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/000170Entacapone 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/000171Entacapone 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/002075Entacapone 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 |
