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Last Updated: March 29, 2024

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INBRIJA Drug Patent Profile


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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 six patents protecting this drug.

This drug has one hundred and three 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

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Summary for INBRIJA
Drug patent expirations by year for INBRIJA
Drug Prices for INBRIJA

See drug prices for INBRIJA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INBRIJA
Generic Entry Date for INBRIJA*:
Constraining patent/regulatory exclusivity:
NDA:
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 INBRIJA
Anatomical Therapeutic Chemical (ATC) Classes for INBRIJA

US Patents and Regulatory Information for INBRIJA

INBRIJA is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INBRIJA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Particulate compositions for pulmonary delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pulmonary delivery for levodopa
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES

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

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

EU/EMA Drug Approvals for INBRIJA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Acorda Therapeutics Ireland Limited Inbrija levodopa EMEA/H/C/004786
Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Authorised no no no 2019-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 13342246
Estimated Expiration: ⤷  Try a Trial

Patent: 13342247
Estimated Expiration: ⤷  Try a Trial

Patent: 13342248
Estimated Expiration: ⤷  Try a Trial

Patent: 17279626
Estimated Expiration: ⤷  Try a Trial

Patent: 18204674
Estimated Expiration: ⤷  Try a Trial

Patent: 18222983
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015010601
Estimated Expiration: ⤷  Try a Trial

Patent: 2015010603
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 90451
Estimated Expiration: ⤷  Try a Trial

Patent: 90454
Estimated Expiration: ⤷  Try a Trial

Patent: 90459
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4918607
Estimated Expiration: ⤷  Try a Trial

Patent: 5120843
Estimated Expiration: ⤷  Try a Trial

Patent: 9106697
Estimated Expiration: ⤷  Try a Trial

Patent: 0833539
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 16821
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 16821
Estimated Expiration: ⤷  Try a Trial

Patent: 16826
Estimated Expiration: ⤷  Try a Trial

Patent: 25611
Estimated Expiration: ⤷  Try a Trial

Patent: 15679
Estimated Expiration: ⤷  Try a Trial

Patent: 57301
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12884
Estimated Expiration: ⤷  Try a Trial

Patent: 13186
Estimated Expiration: ⤷  Try a Trial

Patent: 13187
Estimated Expiration: ⤷  Try a Trial

Patent: 13535
Estimated Expiration: ⤷  Try a Trial

Patent: 14957
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 47786
Estimated Expiration: ⤷  Try a Trial

Patent: 48501
Estimated Expiration: ⤷  Try a Trial

Patent: 69808
Estimated Expiration: ⤷  Try a Trial

Patent: 21629
Estimated Expiration: ⤷  Try a Trial

Patent: 36834
Estimated Expiration: ⤷  Try a Trial

Patent: 15536197
Estimated Expiration: ⤷  Try a Trial

Patent: 15536988
Estimated Expiration: ⤷  Try a Trial

Patent: 15536989
Estimated Expiration: ⤷  Try a Trial

Patent: 18150355
Estimated Expiration: ⤷  Try a Trial

Patent: 18162258
Estimated Expiration: ⤷  Try a Trial

Patent: 19213867
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1008
Estimated Expiration: ⤷  Try a Trial

Patent: 15005767
Estimated Expiration: ⤷  Try a Trial

Patent: 15005768
Estimated Expiration: ⤷  Try a Trial

Patent: 20012506
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8682
Estimated Expiration: ⤷  Try a Trial

Patent: 8684
Estimated Expiration: ⤷  Try a Trial

Patent: 3459
Estimated Expiration: ⤷  Try a Trial

Patent: 7376
Estimated Expiration: ⤷  Try a Trial

Patent: 7378
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 16821
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 16821
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 70987
Estimated Expiration: ⤷  Try a Trial

Patent: 76093
Estimated Expiration: ⤷  Try a Trial

Patent: 15121091
Estimated Expiration: ⤷  Try a Trial

Patent: 15121092
Estimated Expiration: ⤷  Try a Trial

Patent: 18144622
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201706465X
Estimated Expiration: ⤷  Try a Trial

Patent: 201707103S
Estimated Expiration: ⤷  Try a Trial

Patent: 202109328Q
Estimated Expiration: ⤷  Try a Trial

Patent: 201503543P
Estimated Expiration: ⤷  Try a Trial

Patent: 201503547T
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1504058
Estimated Expiration: ⤷  Try a Trial

Patent: 1504060
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2257164
Estimated Expiration: ⤷  Try a Trial

Patent: 2337781
Estimated Expiration: ⤷  Try a Trial

Patent: 2389785
Estimated Expiration: ⤷  Try a Trial

Patent: 150108816
Estimated Expiration: ⤷  Try a Trial

Patent: 150110480
Estimated Expiration: ⤷  Try a Trial

Patent: 210062730
Estimated Expiration: ⤷  Try a Trial

Patent: 210152020
Estimated Expiration: ⤷  Try a Trial

Patent: 220054703
Estimated Expiration: ⤷  Try a Trial

Patent: 230116102
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 44153
Estimated Expiration: ⤷  Try a Trial

Patent: 80271
Estimated Expiration: ⤷  Try a Trial

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
World Intellectual Property Organization (WIPO) 2014074797 ⤷  Try a Trial
China 110833539 超低密度的肺部粉末 (Ultra low density pulmonary powders) ⤷  Try a Trial
Portugal 1318785 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INBRIJA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 92782 Luxembourg ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.