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Last Updated: April 16, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209184

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NDA 209184 describes INBRIJA, which is a drug marketed by Acorda and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the INBRIJA profile page.

The generic ingredient in INBRIJA is levodopa. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levodopa profile page.
Summary for 209184
Tradename:INBRIJA
Applicant:Acorda
Ingredient:levodopa
Patents:18
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209184
Generic Entry Date for 209184*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 209184
Medical Subject Heading (MeSH) Categories for 209184
Suppliers and Packaging for NDA: 209184
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INBRIJA levodopa POWDER;INHALATION 209184 NDA Acorda Therapeutics, Inc. 10144-342 10144-342-04 1 BLISTER PACK in 1 CARTON (10144-342-04) > 4 CAPSULE in 1 BLISTER PACK (10144-342-01)
INBRIJA levodopa POWDER;INHALATION 209184 NDA Acorda Therapeutics, Inc. 10144-342 10144-342-12 3 BLISTER PACK in 1 CARTON (10144-342-12) > 4 CAPSULE in 1 BLISTER PACK (10144-342-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength42MG
Approval Date:Dec 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Sep 19, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
Patent:  Start TrialPatent Expiration:Sep 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES

Expired US Patents for NDA 209184

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
Acorda INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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