STALEVO 200 Drug Patent Profile
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When do Stalevo 200 patents expire, and when can generic versions of Stalevo 200 launch?
Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.
The generic ingredient in STALEVO 200 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
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Summary for STALEVO 200
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 18 |
| Patent Applications: | 85 |
| DailyMed Link: | STALEVO 200 at DailyMed |
Recent Clinical Trials for STALEVO 200
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| Sponsor | Phase |
|---|---|
| Julien Bally | PHASE1 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
| Asan Medical Center | N/A |
US Patents and Regulatory Information for STALEVO 200
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for STALEVO 200
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Start Trial | ⤷ Start Trial |
| Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Start Trial | ⤷ Start Trial |
| Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for STALEVO 200
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Orion Corporation | Levodopa/Carbidopa/Entacapone Orion | levodopa, carbidopa, entacapone | EMEA/H/C/002441Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment. | Authorised | no | no | no | 2011-08-23 | |
| Orion Corporation | Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) | levodopa, carbidopa, entacapone | EMEA/H/C/002785Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. | Authorised | no | no | no | 2013-11-11 | |
| Orion Corporation | Stalevo | levodopa, carbidopa, entacapone | EMEA/H/C/000511Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment. | Authorised | no | no | no | 2003-10-17 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for STALEVO 200
See the table below for patents covering STALEVO 200 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 243491 | PROCEDIMIENTO PARA PREPARAR DERIVADOS DE CATECOL FARMACOLOGICAMENTE ACTIVOS. (PROCEDURE FOR PREPARING PHARMALOGICALLY ACTIVE CATECOL DERIVATIVES.) | ⤷ Start Trial |
| Austria | 148626 | ⤷ Start Trial | |
| Austria | 401053 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STALEVO 200
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0426468 | 91071 | Luxembourg | ⤷ Start Trial | 91071, EXPIRES: 20151101 |
| 0426468 | CA 2004 00007 | Denmark | ⤷ Start Trial | |
| 0426468 | C00426468/01 | Switzerland | ⤷ Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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