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STALEVO 100 Drug Profile
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» See Plans and PricingWhich 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. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-eight patent family members in forty-one countries.
The generic ingredient in STALEVO 100 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.
US ANDA Litigation and Generic Entry Outlook for Stalevo 100
Stalevo 100 was eligible for patent challenges on October 19, 2003.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for STALEVO 100
| International Patents: | 58 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Patent Applications: | 4 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Asan Medical Center | N/A |
| SynAgile Corporation | Phase 2 |
| IRCCS San Raffaele | Phase 2 |
Recent Litigation for STALEVO 100
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Orion Corporation v. Mylan Pharmaceuticals Inc. | 2012-04-26 |
| ORION CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES INC. | 2007-11-13 |
| Orion Corporation v. Wockhardt USA Inc. | 2007-09-13 |
Pharmacology for STALEVO 100
| Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Synonyms for STALEVO 100
| 745835-09-0 |
| Carbidopa mixture with Entacapone and Levodopa |
| Carbidopa, levodopa, and entacapone |
| Carbidopa/levodopa/entacapone |
| DTXSID10225560 |
| ELC200 |
| L-Tyrosine, 3-hydroxy-, mixt. with (2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide and (alphaS)-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid |
| SCHEMBL3808214 |
| Stalevo 125 |
| Stalevo 200 |
| Stalevo 50 |
| Stalevo 75 |
Paragraph IV (Patent) Challenges for STALEVO 100
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 | Start Trial | Start Trial | Y | Start Trial | ||
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 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 | Start Trial | Start Trial |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | Start Trial | Start Trial |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | Start Trial | Start Trial |
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for STALEVO 100
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 222729 | Start Trial |
| Malta | P1012 | Start Trial |
| Yugoslavia | 2289 | Start Trial |
| United Kingdom | 2238047 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for STALEVO 100
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0426468 | 0490007-2 | Sweden | Start 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 | CA 2004 00007 | Denmark | Start Trial | |
| 0426468 | 91071 | Luxembourg | Start Trial | 91071, EXPIRES: 20151101 |
| 0426468 | C00426468/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
