DrugPatentWatch Database Preview
STALEVO 100 Drug Profile
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. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in STALEVO 100 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for STALEVO 100
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Patent Applications: | 3 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STALEVO 100 |
| DailyMed Link: | STALEVO 100 at DailyMed |
Pharmacology for STALEVO 100
| Ingredient-type | Amino Acids, Aromatic |
| 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 |
| DTXSID10225560 |
| 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 200 |
| Stalevo 50 |
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 | Y | ➤ Sign Up | ||
| Orion Pharma | STALEVO 100 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-002 | Jun 11, 2003 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 |
| 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 | ➤ Sign Up |
International Patents for STALEVO 100
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200200106 | ➤ Sign Up |
| Croatia | P20020088 | ➤ Sign Up |
| Denmark | 1189608 | ➤ Sign Up |
| Finland | 109453 | ➤ Sign Up |
| Australia | 5830600 | ➤ Sign Up |
| Norway | 330260 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
