STALEVO 100 Drug Patent Profile
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Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?
Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.
The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
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Summary for STALEVO 100
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 17 |
| Patent Applications: | 5 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STALEVO 100 |
| DailyMed Link: | STALEVO 100 at DailyMed |
Recent Clinical Trials for STALEVO 100
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 |
| SynAgile Corporation | Phase 2 |
Pharmacology for STALEVO 100
| Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
US Patents and Regulatory Information for STALEVO 100
| 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 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | AB | RX | Yes | No | ⤷ 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 100
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for STALEVO 100
| 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 100
See the table below for patents covering STALEVO 100 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 86236 | PROCESSO PARA A PREPARACAO DE DERIVADOS DE CATECOL E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ Sign Up |
| Japan | 4204783 | ⤷ Sign Up | |
| Sweden | 8704751 | ⤷ Sign Up | |
| Estonia | 05473 | Levodopa/karbidopa/entakapooni farmatseutiline preparaat, selle valmistamise meetod ja kasutamine | ⤷ Sign Up |
| Norway | 874966 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STALEVO 100
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >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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