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 ten patents protecting this drug.
This drug has one hundred and two 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: | 102 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Patent Applications: | 4,210 |
| 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 |
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
| Drug Class | Aromatic Amino Acid |
Anatomical Therapeutic Chemical (ATC) Classes for INBRIJA
US Patents and Regulatory Information for INBRIJA
INBRIJA is protected by ten 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
Particulate compositions for pulmonary delivery
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
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
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
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 | |||
| 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 |
| 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
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 |
|---|---|---|---|
| Denmark | 2916821 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 03043585 | ⤷ Try a Trial | |
| Spain | 2487816 | ⤷ Try a Trial | |
| South Korea | 20210152020 | 폐용 초저밀도 분말 (ULTRA LOW DENSITY PULMONARY POWDERS) | ⤷ 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 | 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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