Levodopa - Generic Drug Details

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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levodopa has one hundred and one 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:	101
US Patents:	10
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	435
Patent Applications:	6,919
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
VistaGen Therapeutics, Inc.	Phase 2
University of Minnesota	Early Phase 1
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 2

See all levodopa clinical trials

Pharmacology for levodopa

Drug Class

Aromatic Amino Acid

Medical Subject Heading (MeSH) Categories for levodopa

Antiparkinson Agents

Dopamine Agents

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
Shire	DOPAR	levodopa	TABLET;ORAL	016913-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Roche	LARODOPA	levodopa	CAPSULE;ORAL	016912-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes

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
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Acorda	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018

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

International Patents for levodopa

Country	Patent Number	Title	Estimated Expiration
Canada	2890459	POUDRES PULMONAIRES DE DENSITE ULTRA BASSE (ULTRA LOW DENSITY PULMONARY POWDERS)
Singapore	10201706465X	HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Portugal	1531798
Portugal	2494962

Supplementary Protection Certificates for levodopa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	92782	Luxembourg		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		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226