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Eagle Pharms Company Profile

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What is the competitive landscape for EAGLE PHARMS, and when can generic versions of EAGLE PHARMS drugs launch?

EAGLE PHARMS has five approved drugs.

There are twenty-three US patents protecting EAGLE PHARMS drugs. There is one tentative approval on EAGLE PHARMS drugs.

There are ninety patent family members on EAGLE PHARMS drugs in thirty-four countries and three supplementary protection certificates in three countries.

Summary for Eagle Pharms

International Patents:	90
US Patents:	23
Tradenames:	5
Ingredients:	4
NDAs:	5

Drugs and US Patents for Eagle Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	1,001,053		Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	8,609,707		Y
Eagle Pharms	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	205934-003	Dec 22, 2015	AP	RX	No	No	8,940,786		Y
Eagle Pharms	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;IV (INFUSION)	022434-001	Jun 29, 2011		RX	Yes	Yes	7,589,106		Y
Eagle Pharms	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes	8,609,707		Y
Eagle Pharms	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes	1,001,053		Y

Paragraph IV (Patent) Challenges for EAGLE PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	100 mg/4 mL (25 mg/mL) multiple-dose vials		2017-05-04

Non-Orange Book US Patents for Eagle Pharms

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
8,609,863	Bendamustine pharmaceutical compositions
9,271,964	Treatment using dantrolene
8,461,350	Bendamustine pharmaceutical compositions
9,789,090	Treatment using dantrolene
9,763,880	Non-aqueous taxane formulations and methods of using the same
8,436,190	Bendamustine pharmaceutical compositions

International Patents for Eagle Pharms Drugs

Country	Document Number	Estimated Expiration
Hong Kong	1116073
South Korea	20070094848
Japan	2015510940
World Intellectual Property Organization (WIPO)	2013142359
Russian Federation	2015116260
European Patent Office	2574334

Supplementary Protection Certificates for Eagle Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
/2013	Austria		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
60002	Netherlands		PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Eagle Pharms