SINEMET Drug Patent Profile
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Which patents cover Sinemet, and when can generic versions of Sinemet launch?
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-three 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.
Summary for SINEMET
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 83 |
Patent Applications: | 4,323 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SINEMET |
What excipients (inactive ingredients) are in SINEMET? | SINEMET excipients list |
DailyMed Link: | SINEMET at DailyMed |
Recent Clinical Trials for SINEMET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Los Angeles | Phase 1/Phase 2 |
Laboratorios Andromaco S.A. | Phase 1 |
Northwestern Medical Group | Phase 2 |
Pharmacology for SINEMET
Drug Class | Aromatic Amino Acid |
Anatomical Therapeutic Chemical (ATC) Classes for SINEMET
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-002 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 SINEMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SINEMET
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Amneal Pharma Europe Ltd | Numient | levodopa, carbidopa | EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease |
Withdrawn | no | no | no | 2015-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SINEMET
See the table below for patents covering SINEMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | A490073 | ⤷ Try a Trial | |
Czechoslovakia | 178077 | ⤷ Try a Trial | |
Canada | 919691 | PROCESS FOR PREPARING SUBSTITUTED PHENYLALKANOIC ACIDS AND INTERMEDIATES | ⤷ Try a Trial |
Romania | 62503 | ⤷ Try a Trial | |
Yugoslavia | 35111 | ⤷ Try a Trial | |
Switzerland | 555810 | VERFAHREN ZUR HERSTELLUNG VON L-ALPHA-HYDRAZINO-BETAPHENYLALKANSAEUREN, DEREN SALZEN ODER ESTERN. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |