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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
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Daiichi Sankyo
Cerilliant
Moodys
UBS
Express Scripts
Colorcon

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203312

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NDA 203312 describes RYTARY, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RYTARY profile page.

The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 203312
Tradename:RYTARY
Applicant:Impax Labs Inc
Ingredient:carbidopa; levodopa
Patents:9
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203312
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 203312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Impax Specialty Pharma 64896-661 E 64896-661-01
RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Impax Specialty Pharma 64896-661 E 64896-661-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength23.75MG;95MG
Approval Date:Jan 7, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 7, 2018
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:➤ Try a Free TrialPatent Expiration:May 29, 2022Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Patent:➤ Try a Free TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

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