SINEMET CR Drug Patent Profile
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Which patents cover Sinemet Cr, and what generic alternatives are available?
Sinemet Cr is a drug marketed by Organon Llc and is included in one NDA.
The generic ingredient in SINEMET CR is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sinemet Cr
A generic version of SINEMET CR was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.
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Questions you can ask:
- What is the 5 year forecast for SINEMET CR?
- What are the global sales for SINEMET CR?
- What is Average Wholesale Price for SINEMET CR?
Summary for SINEMET CR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 84 |
Patent Applications: | 460 |
DailyMed Link: | SINEMET CR at DailyMed |
Recent Clinical Trials for SINEMET CR
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 |
US Patents and Regulatory Information for SINEMET CR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 SINEMET CR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SINEMET CR
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 CR
See the table below for patents covering SINEMET CR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Romania | 62503 | ⤷ Sign Up | |
U.S.S.R. | 701530 | METHOD OF PREPARING SUBSTITUTED L-ALPHAHYDRAZINO-BETA-PNENYLPROPIONIC ACIDS | ⤷ Sign Up |
Poland | 96933 | ⤷ Sign Up | |
Australia | 597670 | ⤷ Sign Up | |
Austria | 332381 | ⤷ Sign Up | |
Spain | 413739 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |