INBRIJA Drug Patent Profile

Which patents cover Inbrija, and when can generic versions of Inbrija launch?

Inbrija is a drug marketed by Acorda and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred patent family members in twenty-two countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Inbrija

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INBRIJA

International Patents:	100
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	4,187
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INBRIJA
What excipients (inactive ingredients) are in INBRIJA?	INBRIJA excipients list
DailyMed Link:	INBRIJA at DailyMed

See drug prices for INBRIJA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for INBRIJA

NDA:

209184

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.

Anatomical Therapeutic Chemical (ATC) Classes for INBRIJA

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for INBRIJA

INBRIJA is protected by ten US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INBRIJA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y

Expired US Patents for INBRIJA

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

International Patents for INBRIJA

When does loss-of-exclusivity occur for INBRIJA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INBRIJA around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	2630954
European Patent Office	2916826	POUDRES PULMONAIRES DE DENSITÉ ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
China	105120843	Ultra low density pulmonary powders
Israel	158357	INHALATION DEVICE
Israel	153281
Hong Kong	1213186	用於肺部使用的高劑量左旋多巴膠囊 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Canada	2465675	COMPOSITIONS PARTICULAIRES AMELIOREES DESTINEES A ETRE ADMINISTREES PAR VOIE PULMONAIRE (IMPROVED PARTICULATE COMPOSITIONS FOR PULMONARY DELIVERY)

Supplementary Protection Certificates for INBRIJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226