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Last Updated: May 10, 2024

CARBIDOPA; LEVODOPA - Generic Drug Details

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What are the generic drug sources for carbidopa; levodopa and what is the scope of freedom to operate?

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

International Patents:	32
US Patents:	11
Tradenames:	8
Applicants:	26
NDAs:	34
Finished Product Suppliers / Packagers:	33
Clinical Trials:	183
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
Bronx VA Medical Center	Phase 1
VistaGen Therapeutics, Inc.	Phase 2
University of Minnesota	Early Phase 1

See all CARBIDOPA; LEVODOPA clinical trials

Pharmacology for CARBIDOPA; LEVODOPA

Drug Class	Aromatic Amino Acid

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
Mylan	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	090324-003	Sep 28, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sciegen Pharms Inc	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	214092-001	May 7, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex Inc	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	077120-003	Jun 2, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	210341-001	Jun 5, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	078536-002	Oct 28, 2008	AB	RX	No	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 CARBIDOPA; LEVODOPA

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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	⤷ 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	017555-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	⤷ 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 Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	⤷ 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
>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
South Korea	20100099731	CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF	⤷ Try a Trial
South Korea	101451564		⤷ Try a Trial
China	111954523	左旋多巴分次剂量组合物及用途 (Levodopa fractionated dose composition and use)	⤷ Try a Trial
Israel	263053	תערובות שחרור מבוקרות של ושמושיהן levodopa (Controlled release formulation of levodopa and uses thereof)	⤷ Try a Trial
Japan	2022133449	レボドパ分割用量組成物および使用	⤷ Try a Trial
Japan	5783725		⤷ Try a Trial
China	101910113	Controlled release formulations of levodopa and uses thereof	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.