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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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Levodopa has one hundred and fifty-one patent family members in twenty-six countries.
There are eighteen drug master file entries for levodopa. One supplier is listed for this compound.
Summary for levodopa
| International Patents: | 151 |
| US Patents: | 18 |
| Tradenames: | 4 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 121 |
| Clinical Trials: | 397 |
| Patent Applications: | 6,336 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in levodopa? | levodopa excipients list |
| DailyMed Link: | levodopa at DailyMed |
Recent Clinical Trials for levodopa
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | Early Phase 1 |
| Biohaven Pharmaceuticals, Inc. | Early Phase 1 |
| Emory University | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Valeant Pharm Intl | BENDOPA | levodopa | CAPSULE;ORAL | 016948-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Shire | DOPAR | levodopa | CAPSULE;ORAL | 016913-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | Start Trial | Start Trial |
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | Start Trial | Start Trial |
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | Start Trial | Start Trial |
| Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for levodopa
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 733459 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03080163 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2014074797 | Start Trial |
| European Patent Office | 1381416 | Start Trial |
| Hong Kong | 1213535 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for levodopa
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613296 | 92782 | Luxembourg | Start 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 | Start 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 |
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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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