Entacapone - Generic Drug Details
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What are the generic drug sources for entacapone and what is the scope of freedom to operate?
Entacapone
is the generic ingredient in two branded drugs marketed by Orion Pharma, Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Norvium Bioscience, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for entacapone. Fourteen suppliers are listed for this compound.
Summary for entacapone
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Clinical Trials: | 42 |
Patent Applications: | 7,434 |
Drug Prices: | Drug price trends 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 |
---|---|
The Affiliated Hospital of Qingdao University | Phase 1 |
Xiangya Hospital of Central South University | Early Phase 1 |
Bial - Portela C S.A. | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | ENTACAPONE | entacapone | TABLET;ORAL | 203437-001 | Jun 19, 2015 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Macleods Pharms Ltd | ENTACAPONE | entacapone | TABLET;ORAL | 207210-001 | Jun 5, 2017 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 entacapone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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/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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
Entacapone Market Analysis and Financial Projection Experimental
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