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-two 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.
Summary for SINEMET CR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 7 |
| Clinical Trials: | 83 |
| Patent Applications: | 580 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for SINEMET CR
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 | ⤷ 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 CR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Ireland | 883679 | ⤷ Try a Trial | |
| Japan | H02209 | CONTROL RELEASE COMPOUND OF CARBIDOPA/LEVODOPA | ⤷ Try a Trial |
| Japan | H0667830 | ⤷ Try a Trial | |
| Hong Kong | 56191 | CONTROLLED RELEASE COMBINATION OF CARBIDOPA/LEVODOPA | ⤷ Try a Trial |
| Switzerland | 578512 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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