COMTAN Drug Patent Profile
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When do Comtan patents expire, and what generic alternatives are available?
Comtan is a drug marketed by Orion Pharma and is included in one NDA.
The generic ingredient in COMTAN 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 Comtan
A generic version of COMTAN was approved as entacapone by SUN PHARM on July 16th, 2012.
Summary for COMTAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 100 |
| Clinical Trials: | 7 |
| Patent Applications: | 5,987 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMTAN |
| What excipients (inactive ingredients) are in COMTAN? | COMTAN excipients list |
| DailyMed Link: | COMTAN at DailyMed |
Recent Clinical Trials for COMTAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daniel Claassen | Phase 1 |
| Xiangya Hospital of Central South University | Early Phase 1 |
| Kaichun Wu | Phase 1/Phase 2 |
Pharmacology for COMTAN
| Drug Class | Catechol-O-Methyltransferase Inhibitor |
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for COMTAN
Paragraph IV (Patent) Challenges for COMTAN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| COMTAN | Tablets | entacapone | 200 mg | 020796 | 1 | 2007-04-11 |
US Patents and Regulatory Information for COMTAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for COMTAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for COMTAN
| 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 |
International Patents for COMTAN
See the table below for patents covering COMTAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | 1225762 | COMPOSTI FARMACOLOGICAMENTE ATTIVI, PROCEDIMENTI PER LA LORO PREPARAZIONE E COMPOSIZIONI CHE LI CONTENGONO. | ⤷ Try a Trial |
| Denmark | 623087 | ⤷ Try a Trial | |
| Finland | 107149 | ⤷ Try a Trial | |
| Switzerland | 685436 | Brenzkatechin-Derivate und ihre Verwendung als Arzneistoffe. | ⤷ Try a Trial |
| China | 87108011 | ⤷ Try a Trial | |
| Bulgaria | 60407 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMTAN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0426468 | CA 2004 00007 | Denmark | ⤷ Try a Trial | |
| 0426468 | C00426468/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0426468 | 91071 | Luxembourg | ⤷ Try a Trial | 91071, EXPIRES: 20151101 |
| 0426468 | 0490007-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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