Details for New Drug Application (NDA): 209184
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NDA 209184 describes INBRIJA, which is a drug marketed by Acorda and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the INBRIJA profile page.
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.
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.
Summary for 209184
| Tradename: | INBRIJA |
| Applicant: | Acorda |
| Ingredient: | levodopa |
| Patents: | 10 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209184
Generic Entry Date for 209184*:
Constraining patent/regulatory exclusivity:
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 NDA: 209184
Medical Subject Heading (MeSH) Categories for 209184
Suppliers and Packaging for NDA: 209184
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INBRIJA | levodopa | POWDER;INHALATION | 209184 | NDA | Acorda Therapeutics, Inc. | 10144-342 | 10144-342-04 | 1 BLISTER PACK in 1 CARTON (10144-342-04) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) |
| INBRIJA | levodopa | POWDER;INHALATION | 209184 | NDA | Acorda Therapeutics, Inc. | 10144-342 | 10144-342-12 | 3 BLISTER PACK in 1 CARTON (10144-342-12) / 4 CAPSULE in 1 BLISTER PACK (10144-342-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 42MG | ||||
| Approval Date: | Dec 21, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 22, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 20, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 19, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES | ||||||||
Expired US Patents for NDA 209184
| 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 |
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