LARODOPA Drug Patent Profile
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Which patents cover Larodopa, and when can generic versions of Larodopa launch?
Larodopa is a drug marketed by Roche and is included in one NDA.
The generic ingredient in LARODOPA 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 LARODOPA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,198 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LARODOPA at DailyMed |
Recent Clinical Trials for LARODOPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Arkansas | Phase 4 |
| University of Wisconsin, Madison | Phase 4 |
| Vanderbilt University | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for LARODOPA
US Patents and Regulatory Information for LARODOPA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roche | LARODOPA | levodopa | CAPSULE;ORAL | 016912-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | LARODOPA | levodopa | TABLET;ORAL | 016912-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | LARODOPA | levodopa | CAPSULE;ORAL | 016912-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Roche | LARODOPA | levodopa | CAPSULE;ORAL | 016912-006 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for LARODOPA
| 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 |
