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Last Updated: May 24, 2024

Carbidopa; levodopa - Generic Drug Details


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What are the generic sources for carbidopa; levodopa and what is the scope of patent protection?

Carbidopa; levodopa is the generic ingredient in eight branded drugs marketed by Impax Labs Inc, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Rising, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rubicon, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has thirty-two patent family members in thirteen countries.

Thirty-three suppliers are listed for this compound.

Summary for carbidopa; levodopa
Recent Clinical Trials for carbidopa; levodopa

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bronx VA Medical CenterPhase 1
VistaGen Therapeutics, Inc.Phase 2
University of MinnesotaEarly Phase 1

See all carbidopa; levodopa clinical trials

Pharmacology for carbidopa; levodopa
Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; levodopa
Paragraph IV (Patent) Challenges for CARBIDOPA; LEVODOPA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RYTARY Extended-release Capsules carbidopa; levodopa 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg 203312 1 2015-06-24
RYTARY Extended-release Capsules carbidopa; levodopa 61.25 mg/245 mg 203312 1 2015-06-10

US Patents and Regulatory Information for carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ranbaxy CARBILEV carbidopa; levodopa TABLET, FOR SUSPENSION;ORAL 076643-003 Jun 10, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Elizabeth CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 074260-002 Sep 3, 1993 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Watson Labs CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073383-001 Sep 28, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 076521-002 May 14, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 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

Expired US Patents for carbidopa; levodopa

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
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 ⤷  Sign Up ⤷  Sign Up
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 ⤷  Sign Up ⤷  Sign Up
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for carbidopa; levodopa

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 carbidopa; levodopa

Country Patent Number Title Estimated Expiration
China 101910113 Controlled release formulations of levodopa and uses thereof ⤷  Sign Up
Japan 2015187178 レボドパの放出制御製剤及びその使用 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) ⤷  Sign Up
South Korea 101569604 ⤷  Sign Up
China 111954523 左旋多巴分次剂量组合物及用途 (Levodopa fractionated dose composition and use) ⤷  Sign Up
New Zealand 586870 Controlled release formulations of levodopa, carbidopa andd a caboxylic acid ⤷  Sign Up
South Korea 20150133854 레보도파 방출 제어형 제제 및 이의 용도 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) ⤷  Sign Up
Brazil 112020017422 composição de dose fracionada de levodopa e uso ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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