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. Four 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: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 17 |
Patent Applications: | 5 |
Formulation / Manufacturing: | see details |
DailyMed Link: | STALEVO 200 at DailyMed |
![STALEVO 200 drug patent expirations Drug patent expirations by year for STALEVO 200](/p/graph/s/t/STALEVO_200-patent-expirations.png)
Recent Clinical Trials for STALEVO 200
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
Asan Medical Center | N/A |
IRCCS San Raffaele | Phase 2 |
Pharmacology for STALEVO 200
Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Orion Pharma | STALEVO 200 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-004 | Aug 2, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>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/002441 Levodopa/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/002785 Corbilta 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/000511 Stalevo 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 |
---|---|---|---|
Japan | 3157846 | ⤷ Sign Up | |
Austria | 245417 | ⤷ Sign Up | |
Poland | 152642 | ⤷ Sign Up | |
Turkey | 200103763 | ⤷ Sign Up | |
Germany | 69022166 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STALEVO 200
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0426468 | CA 2004 00007 | Denmark | ⤷ Sign Up | |
0426468 | C00426468/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
0426468 | 91071 | Luxembourg | ⤷ Sign Up | 91071, EXPIRES: 20151101 |
0426468 | 0490007-2 | Sweden | ⤷ Sign Up | 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 |