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

International Patents:	32
US Patents:	11
Tradenames:	8
Applicants:	26
NDAs:	34
Finished Product Suppliers / Packagers:	33
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 Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ani Pharms	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	073587-003	Jun 29, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	077828-001	Aug 23, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy	CARBILEV	carbidopa; levodopa	TABLET, FOR SUSPENSION;ORAL	076643-003	Jun 10, 2005		DISCN	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
Avion Pharms	DHIVY	carbidopa; levodopa	TABLET;ORAL	214869-001	Nov 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	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
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	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
>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
Israel	206756	תערובות שחרור מבוקרות של levodopa ושימושיהן (Controlled release formulations of levodopa and uses thereof)	⤷ Sign Up
Japan	5783725		⤷ Sign Up
South Korea	101451564		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2019191353		⤷ Sign Up
Canada	2711014	FORMULATIONS À LIBERATION CONTRÔLEE DE LEVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF)	⤷ Sign Up
Australia	2008343787	Controlled release formulations of levodopa and uses thereof	⤷ Sign Up
Israel	248520	תערובות שחרור מבוקרות של levodopa ושמושיהן (Controlled release formulation of levodopa and uses thereof)	⤷ Sign Up
>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.