CARBIDOPA; LEVODOPA - Generic Drug Details

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
University of Minnesota	Early Phase 1
VistaGen Therapeutics, Inc.	Phase 2

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scs	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	074080-001	Mar 25, 1994		DISCN	No	No
Ranbaxy	CARBILEV	carbidopa; levodopa	TABLET, FOR SUSPENSION;ORAL	076643-002	Jun 10, 2005		DISCN	No	No
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y
Scs	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	074080-002	Mar 25, 1994		DISCN	No	No
Kv Pharm	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	076663-001	Jun 24, 2004		DISCN	No	No
Rubicon	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	216505-002	Sep 21, 2022	AB	RX	No	No
Sun Pharm	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET, ORALLY DISINTEGRATING;ORAL	078690-002	Jul 31, 2009		RX	No	No

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
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015

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

International Patents for CARBIDOPA; LEVODOPA

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2234963	FORMULATIONS À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF)
Canada	2711014	FORMULATIONS À LIBERATION CONTRÔLEE DE LEVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF)
South Africa	201005309	CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF
China	111954523	左旋多巴分次剂量组合物及用途 (Levodopa fractionated dose composition and use)
Japan	6033373
Israel	263053	תערובות שחרור מבוקרות של ושמושיהן levodopa (Controlled release formulation of levodopa and uses thereof)
Japan	2017014295	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)