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: | 445 |
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 |
---|---|
Centro Hospitalar de Lisboa Central | N/A |
The Affiliated Hospital of Qingdao University | Phase 1 |
UCB Biopharma SRL | Phase 2 |
Pharmacology for LEVODOPA
Drug Class | Aromatic Amino Acid |
Medical Subject Heading (MeSH) Categories for LEVODOPA
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Shire | DOPAR | levodopa | CAPSULE;ORAL | 016913-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Valeant Pharm Intl | BENDOPA | levodopa | CAPSULE;ORAL | 016948-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Shire | DOPAR | levodopa | TABLET;ORAL | 016913-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Acorda | INBRIJA | levodopa | POWDER;INHALATION | 209184-001 | Dec 21, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
European Patent Office | 3957301 | POUDRES PULMONAIRES DE DENSITÉ ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS) | ⤷ Sign Up |
European Patent Office | 2494962 | Apport pulmonaire de levodopa (Pulmonary delivery for levodopa) | ⤷ Sign Up |
South Korea | 102337781 | ⤷ Sign Up | |
South Korea | 20210152020 | 폐용 초저밀도 분말 (ULTRA LOW DENSITY PULMONARY POWDERS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEVODOPA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1613296 | CR 2015 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226 |
1613296 | 92782 | Luxembourg | ⤷ Sign Up | 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 |
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