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Rucaparib camsylate - Generic Drug Details

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What are the generic drug sources for rucaparib camsylate and what is the scope of rucaparib camsylate patent protection?

Rucaparib camsylate is the generic ingredient in one branded drug marketed by Clovis Oncology Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rucaparib camsylate has two hundred and thirty-six patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for rucaparib camsylate

International Patents:	236
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	1
Patent Applications:	2
DailyMed Link:	rucaparib camsylate at DailyMed

Pharmacology for rucaparib camsylate

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for rucaparib camsylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No			Y	Y
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for rucaparib camsylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,449,464	Phthalazinone derivatives
7,662,818	Phthalazinone derivatives
7,981,889	Phthalazinone derivatives
8,912,187	Phthalazinone derivatives

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International Patents for rucaparib camsylate

Country	Document Number	Estimated Expiration
Israel	176013
European Patent Office	1140936
Norway	20060906
Japan	2006519827

Supplementary Protection Certificates for rucaparib camsylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
500012	Hungary		PRODUCT NAME: OLAPARIB
2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
0150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216