SINEMET Drug Patent Profile
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When do Sinemet patents expire, and what generic alternatives are available?
Sinemet is a drug marketed by Organon and Organon Llc and is included in two NDAs.
The generic ingredient in SINEMET is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sinemet
A generic version of SINEMET was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.
US Patents and Regulatory Information for SINEMET
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SINEMET
See the table below for patents covering SINEMET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 413744 | ⤷ Start Trial | |
| Austria | 318573 | ⤷ Start Trial | |
| Spain | 413738 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SINEMET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3209302 | 2390502-9 | Sweden | ⤷ Start Trial | PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
