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Hospira Company Profile

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

HOSPIRA has five hundred and ten approved drugs.

There are nine US patents protecting HOSPIRA drugs. There are nine tentative approvals on HOSPIRA drugs.

Summary for Hospira

US Patents:	9
Tradenames:	329
Ingredients:	203
NDAs:	510
Patent Litigation for Hospira:	See patent lawsuits for Hospira
PTAB Cases with Hospira as petitioner:	See PTAB cases with Hospira as petitioner

Drugs and US Patents for Hospira

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	FUROSEMIDE	furosemide	INJECTABLE;INJECTION	070578-001	Jul 8, 1987		DISCN	No	No
Hospira	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	INJECTABLE;INJECTION	083838-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	heparin sodium	INJECTABLE;INJECTION	018916-003	Jan 31, 1984		DISCN	No	No

Expired US Patents for Hospira

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	4,910,214*PED
Hospira	BRETYLOL	bretylium tosylate	INJECTABLE;INJECTION	017954-001	Approved Prior to Jan 1, 1982	RE29618
Hospira Inc	NIPENT	pentostatin	INJECTABLE;INJECTION	020122-001	Oct 11, 1991	3,923,785

Paragraph IV (Patent) Challenges for HOSPIRA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	4 mcg/mL, 50 mL and 100 mL vials		2013-12-26
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Injection	100 mcg/mL		2009-04-08
	Injection	4 mcg/mL, 20 mL vials		2015-09-30
	Injection	1 mg/mL, 50 mL vials		2011-12-16

Non-Orange Book US Patents for Hospira

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
8,436,033	Methods of treatment using a dexmedetomidine premix formulation

International Patents for Hospira Drugs

Country	Document Number	Estimated Expiration
Russian Federation	2630597
Slovakia	14362000
Hungary	E028339

Supplementary Protection Certificates for Hospira Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2002	Austria		PRODUCT NAME: LINEZOLID; NAT. REGISTRATION NO/DATE: 1-24227 - 1-24230 20011009; FIRST REGISTRATION: GB PL 00032/0259 - PL 00032/0262 20010105
2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
00653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906

Similar Applicant Names

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

• Hospira
• Hospira Inc
• Hospira Worldwide