ROTIGOTINE - Generic Drug Details

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What are the generic sources for rotigotine and what is the scope of freedom to operate?

Rotigotine is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rotigotine has eighty-nine patent family members in thirty countries.

There are seven drug master file entries for rotigotine. One supplier is listed for this compound.

Summary for ROTIGOTINE

International Patents:	89
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	81
Patent Applications:	2,960
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROTIGOTINE
What excipients (inactive ingredients) are in ROTIGOTINE?	ROTIGOTINE excipients list
DailyMed Link:	ROTIGOTINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ROTIGOTINE

Generic Entry Date for ROTIGOTINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: FILM, EXTENDED RELEASE;TRANSDERMAL

^*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 ROTIGOTINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Virginia Commonwealth University	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 2
Hoffmann-La Roche	Phase 1

See all ROTIGOTINE clinical trials

Pharmacology for ROTIGOTINE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ROTIGOTINE

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for ROTIGOTINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEUPRO	Extended-release Transdermal Film	rotigotine	1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr	021829	1	2013-11-26

US Patents and Regulatory Information for ROTIGOTINE

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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
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-001	May 9, 2007		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-003	May 9, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 ROTIGOTINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	⤷ Sign Up	⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007	⤷ Sign Up	⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-005	Apr 2, 2012	⤷ Sign Up	⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-002	May 9, 2007	⤷ Sign Up	⤷ Sign Up
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829-004	Apr 2, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ROTIGOTINE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
UCB Pharma S.A.	Leganto	rotigotine	EMEA/H/C/002380 Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).	Withdrawn	no	no	no	2011-06-16
UCB Pharma S.A.	Neupro	rotigotine	EMEA/H/C/000626 Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations).Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.	Authorised	no	no	no	2006-02-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ROTIGOTINE

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Country	Patent Number	Title	Estimated Expiration
Brazil	0313091	Sistema de liberação transdérmica aperfeiçoado para a administração de rotigotina	⤷ Sign Up
Germany	60304477		⤷ Sign Up
Norway	333297		⤷ Sign Up
Denmark	2515887		⤷ Sign Up
Germany	60309329		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ROTIGOTINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1033978	24/2006	Austria	⤷ Sign Up	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 - EU/1/05/331/013 20060215
1033978	06C0025	France	⤷ Sign Up	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001 20060215
1033978	C300236	Netherlands	⤷ Sign Up	PRODUCT NAME: ROTIGOTINE; REGISTRATION NO/DATE: EU/1/05/331/001-013 20060215
1033978	CA 2006 00020	Denmark	⤷ Sign Up	PRODUCT NAME: ROTIGOTINE
1033978	SZ 24/2006	Austria	⤷ Sign Up	PRODUCT NAME: ROTIGOTINE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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