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 Merz Pharms, 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
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

See all LEVODOPA clinical trials

Pharmacology for LEVODOPA

Drug Class	Aromatic Amino Acid

Medical Subject Heading (MeSH) Categories for LEVODOPA

Antiparkinson Agents
Dopamine Agents

Anatomical Therapeutic Chemical (ATC) Classes for LEVODOPA

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for LEVODOPA

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Valeant Pharm Intl	BENDOPA	levodopa	CAPSULE;ORAL	016948-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roche	LARODOPA	levodopa	TABLET;ORAL	016912-004	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018	⤷ Sign Up	⤷ Sign Up
Merz Pharms	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

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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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014074796		⤷ Sign Up
Spain	2487816		⤷ Sign Up
Australia	2018204674	High Dose Levodopa Capsules For Pulmonary Use	⤷ Sign Up
Mexico	2015005768	POLVOS PULMONARES DE ULTRA BAJA DENSIDAD. (ULTRA LOW DENSITY PULMONARY POWDERS.)	⤷ Sign Up
South Korea	20150110480	폐에서의 사용을 위한 고용량 레보도파 캡슐 (HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE)	⤷ Sign Up
Brazil	112015010601		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LEVODOPA

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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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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.