STALEVO 50 Drug Patent Profile
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Which patents cover Stalevo 50, and what generic alternatives are available?
Stalevo 50 is a drug marketed by Orion Pharma and is included in one NDA.
The generic ingredient in STALEVO 50 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.
Summary for STALEVO 50
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 17 |
Patent Applications: | 7 |
Formulation / Manufacturing: | see details |
DailyMed Link: | STALEVO 50 at DailyMed |
Recent Clinical Trials for STALEVO 50
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 50
Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for STALEVO 50
US Patents and Regulatory Information for STALEVO 50
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 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | 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 STALEVO 50
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for STALEVO 50
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 50
See the table below for patents covering STALEVO 50 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Latvia | 10236 | CATECHOL DERIVATIVES | ⤷ Try a Trial |
Slovakia | 19232001 | Farmaceutický preparát s levodopou /karbidopou/ entacapónom (LEVODOPA / CARBIDOPA / ENTACAPONE PHARMACEUTICAL PREPARATION) | ⤷ Try a Trial |
Ireland | 873242 | ⤷ Try a Trial | |
European Patent Office | 0444899 | Dérivés du catéchol, ses sels, esters physiologiquement acceptables et leur utilisation pour le traitement du dammage du tissu induit par la peroxidation de la graisse (Catechol derivatives, their physiologically acceptable salts, esters and their use in the treatment of tissue damage induced by lipid peroxidation) | ⤷ Try a Trial |
Norway | 20110090 | ⤷ Try a Trial | |
Serbia | 50368 | LEVODOPA/KARBIDOPA/ENTAKAPON FARMACEUTSKI PREPARAT (LEVODOPA/CARBIDOPA/ENTACAPONE PHARMACEUTICAL PREPARATION) | ⤷ Try a Trial |
Yugoslavia | 47790 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STALEVO 50
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0426468 | 91071 | Luxembourg | ⤷ Try a Trial | 91071, EXPIRES: 20151101 |
0426468 | CA 2004 00007 | Denmark | ⤷ Try a Trial | |
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 |
0426468 | C00426468/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |