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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Questions you can ask:
- What is the 5 year forecast for INBRIJA?
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INBRIJA
*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
| Drug Class | Aromatic Amino Acid |
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 | |||
| >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 |
| >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 |
|---|---|---|---|
| Japan | 2019213867 | 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) | ⤷ Sign Up |
| South Korea | 20150110480 | 폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE) | ⤷ Sign Up |
| Australia | 2013342246 | High dose levodopa capsules for pulmonary use | ⤷ Sign Up |
| Canada | 2890451 | CAPSULES DE LEVODOPA A DOSE ELEVEE POUR UNE UTILISATION PULMONAIRE (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE) | ⤷ 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 | 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 |
| 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 |
| >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.
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