Levodopa - Generic Drug Details
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What are the generic drug sources for levodopa and what is the scope of patent protection?
Levodopa
is the generic ingredient in four branded drugs marketed by Valeant Pharm Intl, Shire, Roche, and Acorda, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Levodopa has one hundred and three patent family members in twenty-two countries.
There are eighteen drug master file entries for levodopa. One supplier is listed for this compound.
Summary for levodopa
| International Patents: | 103 |
| US Patents: | 6 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 439 |
| Patent Applications: | 6,932 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in levodopa? | levodopa excipients list |
| DailyMed Link: | levodopa at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for levodopa
Generic Entry Date for levodopa*:
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.
Recent Clinical Trials for levodopa
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Intra-Cellular Therapies, Inc. | Phase 2 |
| Georgetown University | Phase 4 |
| Bronx VA Medical Center | Phase 1 |
Pharmacology for levodopa
| Drug Class | Aromatic Amino Acid |
Medical Subject Heading (MeSH) Categories for levodopa
US Patents and Regulatory Information for levodopa
| 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 | 016912-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Valeant Pharm Intl | BENDOPA | levodopa | CAPSULE;ORAL | 016948-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 | |||
| 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 | ||||
| >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 levodopa
| 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 levodopa
| 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 levodopa
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2006507218 | ⤷ Try a Trial | |
| China | 104918607 | High dose levodopa capsules for pulmonary use | ⤷ Try a Trial |
| Portugal | 2494962 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 03079992 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for levodopa
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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