STALEVO 50 Drug Patent Profile
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When do Stalevo 50 patents expire, 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: | 1 |
| Clinical Trials: | 17 |
| Patent Applications: | 21 |
| 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 |
| >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 |
|---|---|---|---|
| Czechoslovakia | 8808439 | ⤷ Try a Trial | |
| Slovakia | 19232001 | Farmaceutický preparát s levodopou /karbidopou/ entacapónom (LEVODOPA / CARBIDOPA / ENTACAPONE PHARMACEUTICAL PREPARATION) | ⤷ Try a Trial |
| Japan | 4885896 | ⤷ 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 | 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.
ISSN: 2162-2639
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