Details for New Drug Application (NDA): 209184

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NDA 209184 describes INBRIJA, which is a drug marketed by Merz Pharms and is included in one NDA. It is available from one supplier. There are six 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:	Merz Pharms
Ingredient:	levodopa
Patents:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209184

Generic Entry Date for 209184^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Antiparkinson Agents
Dopamine Agents

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	Merz Pharmaceuticals, LLC, a subsidiary of Merz Therapeutics GmbH	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	Merz Pharmaceuticals, LLC, a subsidiary of Merz Therapeutics GmbH	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:	RX	Dosage:	POWDER;INHALATION			Strength	42MG
Approval Date:	Dec 21, 2018	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 22, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Nov 16, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Nov 16, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209184

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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