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RYTARY Drug Profile

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When do Rytary patents expire, and when can generic versions of Rytary launch?

Rytary is a drug marketed by Impax Labs Inc and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-seven patent family members in fourteen countries.

The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for RYTARY

International Patents:	37
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	3
Patent Applications:	30
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RYTARY
Drug Sales Revenues:	Drug sales revenues for RYTARY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYTARY
Prior Art and Litigation Support	Order Prior Art and Litigation support for RYTARY
DailyMed Link:	RYTARY at DailyMed

Pharmacology for RYTARY

Drug Class

Aromatic Amino Acid

Synonyms for RYTARY

(2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid; (2S)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid

500019-90-9

57308-51-7

AC1L2XHE

Carbidopa / Levodopa

CARBIDOPA AND LEVODOPA

Carbidopa Levodopa

Carbidopa mixture with Levodopa

Carbidopa-L-dopa mixt

Carbidopa-L-dopa mixt.

Carbidopa-levodopa (1:10)

Carbidopa-levodopa ER

Carbidopa-levodopa extended release

Carbidopa-levodopa mixt

Carbidopa-levodopa mixt.

carbidopa, levodopa drug combination

CHF 1512

Co-careldopa

CR-3

CR-5

DM-1992

Dopabain

Duodopa

Duopa

IPX 066

IPX066

Isicom

IVTMXOXVAHXCHI-YXLMWLKOSA-N

L-Tyrosine, 3-hydroxy-, mixt. with (S)-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid

L-Tyrosine, 3-hydroxy-, mixt. with (S)-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid (10:1)

Levodopa / carbidopa

levodopa carbidopa

Levodopa-carbidopa (10:1)

Levodopa/Carbidopa Solution

LS-158296

Nacom

Nakom

ND 0612

ND0612

SCHEMBL2049245

Sinemet CR

Sinemet CR4

US Patents and Regulatory Information for RYTARY

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	203312-002	Jan 7, 2015		RX	Yes	No			Y
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y
Impax Labs Inc	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y

Paragraph IV (Patent) Challenges for RYTARY

Drugname	Dosage	Strength	RLD	Date
	Extended-release Capsules	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg
	Extended-release Capsules	61.25 mg/245 mg

International Patents for RYTARY

Country	Patent Number	Estimated Expiration
Japan	2017014295
European Patent Office	2234963
South Korea	101752080
Taiwan	200706182
New Zealand	586870
World Intellectual Property Organization (WIPO)	2006073729