You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 203312


✉ Email this page to a colleague

« Back to Dashboard


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 eight 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. Thirty-three 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:8
Pharmacology for NDA: 203312
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 Amneal Pharmaceuticals LLC 64896-661 64896-661-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)
RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312 NDA Amneal Pharmaceuticals LLC 64896-661 64896-661-09 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (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
Patent:⤷  Try a TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE
Patent:⤷  Try a TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Patent:⤷  Try a TrialPatent Expiration:Dec 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Expired US Patents for NDA 203312

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.