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STALEVO 100 Drug Profile
When do Stalevo 100 patents expire, 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.
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 |
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for STALEVO 100
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 25/100/200 mg and 37.5/150/200 mg | ➤ Subscribe | Start Trial |
International Patents for STALEVO 100
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1189608 | Start Trial |
| Italy | MI20001450 | Start Trial |
| Slovakia | 286451 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
