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 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	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Abbvie	DUOPA	carbidopa; levodopa	SUSPENSION;ENTERAL	203952-001	Jan 9, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	090324-001	Sep 28, 2009	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
>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	101451564		⤷ Sign Up
New Zealand	586870	Controlled release formulations of levodopa, carbidopa andd a caboxylic acid	⤷ Sign Up
China	101910113	Controlled release formulations of levodopa and uses thereof	⤷ Sign Up
Japan	6033373		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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