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STALEVO 100 Drug Profile
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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-six patent family members in forty countries.
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
| International Patents: | 56 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 16 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STALEVO 100 |
| DailyMed Link: | STALEVO 100 at DailyMed |
Generic Entry Opportunity Date for STALEVO 100
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
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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 |
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International Patents for STALEVO 100
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0101984 | ➤ Sign Up |
| Canada | 2378469 | ➤ Sign Up |
| Italy | MI20001450 | ➤ Sign Up |
| Eurasian Patent Organization | 200200106 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
