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Last Updated: November 24, 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 Merz Pharms 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
International Patents:103
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 134
Patent Applications: 3,757
Drug Prices: Drug price information for INBRIJA
What excipients (inactive ingredients) are in INBRIJA?INBRIJA excipients list
DailyMed Link:INBRIJA at DailyMed
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

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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Capsules containing high doses of levodopa for pulmonary use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pulmonary delivery for levodopa
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Merz Pharms INBRIJA levodopa POWDER;INHALATION 209184-001 Dec 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
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
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

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
Patent: High dose levodopa capsules for pulmonary use
Estimated Expiration: ⤷  Sign Up

Patent: 13342247
Patent: Dosator for filling a capsule with powder
Estimated Expiration: ⤷  Sign Up

Patent: 13342248
Patent: Ultra low density pulmonary powders
Estimated Expiration: ⤷  Sign Up

Patent: 17279626
Patent: Dosator For Filling A Capsule With Powder
Estimated Expiration: ⤷  Sign Up

Patent: 18204674
Patent: High Dose Levodopa Capsules For Pulmonary Use
Estimated Expiration: ⤷  Sign Up

Patent: 18222983
Patent: Ultra Low Density Pulmonary Powders
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015010601
Estimated Expiration: ⤷  Sign Up

Patent: 2015010603
Patent: CÁPSULAS DE LEVODOPA DE DOSE ALTA PARA O USO PULMONAR
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 90451
Patent: CAPSULES DE LEVODOPA A DOSE ELEVEE POUR UNE UTILISATION PULMONAIRE (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 90454
Patent: APPAREIL DE DOSAGE POUR REMPLIR UNE CAPSULE AVEC UNE POUDRE SECHE (DOSATOR FOR FILLING A CAPSULE WITH POWDER)
Estimated Expiration: ⤷  Sign Up

Patent: 90459
Patent: POUDRES PULMONAIRES DE DENSITE ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 4918607
Patent: High dose levodopa capsules for pulmonary use
Estimated Expiration: ⤷  Sign Up

Patent: 5120843
Patent: Ultra low density pulmonary powders
Estimated Expiration: ⤷  Sign Up

Patent: 9106697
Patent: 用于肺部使用的高剂量左旋多巴胶囊 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 0833539
Patent: 超低密度的肺部粉末 (Ultra low density pulmonary powders)
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 16821
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 16821
Patent: CAPSULES DE LÉVODOPA À DOSE ÉLEVÉE POUR UNE UTILISATION PULMONAIRE (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 16826
Patent: POUDRES PULMONAIRES DE DENSITÉ ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 25611
Patent: APPAREIL DE DOSAGE POUR REMPLIR UNE CAPSULE AVEC UNE POUDRE SÈCHE (DOSATOR FOR FILLING A CAPSULE WITH POWDER)
Estimated Expiration: ⤷  Sign Up

Patent: 15679
Patent: CAPSULES DE LÉVODOPA À DOSE ÉLEVÉE POUR UNE UTILISATION PULMONAIRE (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 57301
Patent: POUDRES PULMONAIRES DE DENSITÉ ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 12884
Patent: 超低密度的肺部粉末 (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 13186
Patent: 用於肺部使用的高劑量左旋多巴膠囊 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 13187
Patent: 超低密度的肺部粉末 (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 13535
Patent: 用粉末填充膠囊的劑量分配器 (DOSATOR FOR FILLING A CAPSULE WITH POWDER)
Estimated Expiration: ⤷  Sign Up

Patent: 14957
Patent: 用於肺部使用的高劑量左旋多巴膠囊 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 47786
Estimated Expiration: ⤷  Sign Up

Patent: 48501
Estimated Expiration: ⤷  Sign Up

Patent: 69808
Estimated Expiration: ⤷  Sign Up

Patent: 21629
Estimated Expiration: ⤷  Sign Up

Patent: 36834
Estimated Expiration: ⤷  Sign Up

Patent: 15536197
Patent: 乾燥粉末を含むカプセルを充填する投与装置
Estimated Expiration: ⤷  Sign Up

Patent: 15536988
Patent: 肺使用のための高服用量のレボドパを含むカプセル
Estimated Expiration: ⤷  Sign Up

Patent: 15536989
Patent: 超低密度肺粉剤
Estimated Expiration: ⤷  Sign Up

Patent: 18150355
Patent: 肺使用のための高服用量のレボドパを含むカプセル (CAPSULES CONTAINING HIGH DOSES OF LEVODOPA FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 18162258
Patent: 超低密度肺粉剤 (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 19213867
Patent: 乾燥粉末を含むカプセルを充填する投与装置 (DOSING APPARATUS FOR FILLING CAPSULE WITH DRY POWDER)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 1008
Patent: POLVOS PULMONARES DE ULTRA BAJA DENSIDAD. (ULTRA LOW DENSITY PULMONARY POWDERS.)
Estimated Expiration: ⤷  Sign Up

Patent: 15005767
Patent: CÁPSULAS CON ALTAS DOSIS DE LEVODOPA PARA USO PULMONAR. (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE.)
Estimated Expiration: ⤷  Sign Up

Patent: 15005768
Patent: POLVOS PULMONARES DE ULTRA BAJA DENSIDAD. (ULTRA LOW DENSITY PULMONARY POWDERS.)
Estimated Expiration: ⤷  Sign Up

Patent: 20012506
Patent: CAPSULAS CON ALTAS DOSIS DE LEVODOPA PARA USO PULMONAR. (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8682
Patent: Dosator apparatus for filling a capsule with dry powder
Estimated Expiration: ⤷  Sign Up

Patent: 8684
Patent: High dose levodopa capsules for pulmonary use
Estimated Expiration: ⤷  Sign Up

Patent: 3459
Patent: Dosator for filling a capsule with dry powder
Estimated Expiration: ⤷  Sign Up

Patent: 7376
Patent: High dose levodopa capsules for pulmonary use
Estimated Expiration: ⤷  Sign Up

Patent: 7378
Patent: Ultra low density pulmonary powders
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 16821
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 16821
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 70987
Patent: ПОРОШКИ ДЛЯ ИНГАЛЯЦИИ С УЛЬТРАНИЗКОЙ ПЛОТНОСТЬЮ (ULTRA LOW DENSITY INHALATION POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 76093
Patent: КАПСУЛЫ, СОДЕРЖАЩИЕ ВЫСОКИЕ ДОЗЫ ЛЕВОДОПЫ, ДЛЯ ПРИМЕНЕНИЯ ПУТЕМ ИНГАЛЯЦИИ (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 15121091
Patent: ПОРОШКИ ДЛЯ ИНГАЛЯЦИИ С УЛЬТРАНИЗКОЙ ПЛОТНОСТЬЮ
Estimated Expiration: ⤷  Sign Up

Patent: 15121092
Patent: КАПСУЛЫ, СОДЕРЖАЩИЕ ВЫСОКИЕ ДОЗЫ ЛЕВОДОПЫ, ДЛЯ ПРИМЕНЕНИЯ ПУТЕМ ИНГАЛЯЦИИ
Estimated Expiration: ⤷  Sign Up

Patent: 18144622
Patent: КАПСУЛЫ, СОДЕРЖАЩИЕ ВЫСОКИЕ ДОЗЫ ЛЕВОДОПЫ, ДЛЯ ПРИМЕНЕНИЯ ПУТЕМ ИНГАЛЯЦИИ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201706465X
Patent: HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Estimated Expiration: ⤷  Sign Up

Patent: 201707103S
Patent: ULTRA LOW DENSITY PULMONARY POWDERS
Estimated Expiration: ⤷  Sign Up

Patent: 202109328Q
Patent: HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Estimated Expiration: ⤷  Sign Up

Patent: 201503543P
Patent: HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Estimated Expiration: ⤷  Sign Up

Patent: 201503547T
Patent: ULTRA LOW DENSITY PULMONARY POWDERS
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1504058
Patent: HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Estimated Expiration: ⤷  Sign Up

Patent: 1504060
Patent: ULTRA LOW DENSITY PULMONARY POWDERS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2257164
Estimated Expiration: ⤷  Sign Up

Patent: 2337781
Estimated Expiration: ⤷  Sign Up

Patent: 2389785
Estimated Expiration: ⤷  Sign Up

Patent: 150108816
Patent: ULTRA LOW DENSITY PULMONARY POWDERS
Estimated Expiration: ⤷  Sign Up

Patent: 150110480
Patent: 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 210062730
Patent: 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 210152020
Patent: 폐용 초저밀도 분말 (ULTRA LOW DENSITY PULMONARY POWDERS)
Estimated Expiration: ⤷  Sign Up

Patent: 220054703
Patent: 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Patent: 230116102
Patent: 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 44153
Estimated Expiration: ⤷  Sign Up

Patent: 80271
Estimated Expiration: ⤷  Sign Up

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
Singapore 11201503543P HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE ⤷  Sign Up
Australia 2003218307 PULMONARY DELIVERY FOR LEVODOPA ⤷  Sign Up
Japan 2018162258 超低密度肺粉剤 (ULTRA LOW DENSITY PULMONARY POWDERS) ⤷  Sign Up
Japan 2004526523 ⤷  Sign Up
Russian Federation 2676093 КАПСУЛЫ, СОДЕРЖАЩИЕ ВЫСОКИЕ ДОЗЫ ЛЕВОДОПЫ, ДЛЯ ПРИМЕНЕНИЯ ПУТЕМ ИНГАЛЯЦИИ (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE) ⤷  Sign Up
Canada 2477653 MOYENS DE PERFORATION S'UTILISANT DANS UN DISPOSITIF D'INHALATION (PUNCTURING MEANS FOR USE IN AN INHALATION DEVICE) ⤷  Sign Up
>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 ⤷  Sign Up 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 ⤷  Sign Up 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.