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 nine branded drugs marketed by Impax, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, 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, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-six NDAs. There are twenty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has sixty-four patent family members in fifteen countries.

Thirty-five suppliers are listed for this compound.

Summary for carbidopa; levodopa

International Patents:	64
US Patents:	21
Tradenames:	9
Applicants:	26
NDAs:	36
Finished Product Suppliers / Packagers:	35
Clinical Trials:	185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbidopa; levodopa
DailyMed Link:	carbidopa; levodopa at DailyMed

Recent Clinical Trials for carbidopa; levodopa

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	Phase 1
Bronx VA Medical Center	Phase 1
VistaGen Therapeutics, Inc.	Phase 2

See all carbidopa; levodopa clinical trials

Pharmacology for carbidopa; levodopa

Drug Class	Aromatic Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; levodopa

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, ORALLY DISINTEGRATING;ORAL	090631-001	Jun 8, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073607-001	Aug 28, 1992	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073618-001	Aug 28, 1992	AB	RX	No	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 carbidopa; levodopa

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	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
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	⤷ Sign Up	⤷ Sign Up
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for carbidopa; levodopa

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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

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Country	Patent Number	Title	Estimated Expiration
Colombia	2023009085	Pauta posológica de levodopa	⤷ Sign Up
South Korea	20100099731	CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF	⤷ Sign Up
European Patent Office	3054929	FORMULATIONS MUCOADHÉSIVES À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET/OU D'ESTERS DE LÉVODOPA ET LEURS UTILISATIONS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)	⤷ Sign Up
Spain	2804348		⤷ Sign Up
Canada	2926082	FORMULATIONS MUCOADHESIVES A LIBERATION CONTROLEE DE LEVODOPA ET/OU D'ESTERS DE LEVODOPA ET LEURS UTILISATIONS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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