Hospira Company Profile

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

HOSPIRA has five hundred and seventeen approved drugs.

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

There are seventy patent family members on HOSPIRA drugs in thirty-eight countries and four hundred and twenty-two supplementary protection certificates in sixteen countries.

Summary for Hospira

International Patents:	70
US Patents:	9
Tradenames:	333
Ingredients:	210
NDAs:	517
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	IOPAMIDOL-250	iopamidol	INJECTABLE;INJECTION	074898-002	Dec 30, 1997		DISCN	No	No
Hospira	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dobutamine hydrochloride	INJECTABLE;INJECTION	020201-006	Jul 7, 1994	AP	RX	Yes	Yes
Hospira	MARCAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%	heparin sodium	INJECTABLE;INJECTION	018911-005	Jan 30, 1985		DISCN	No	No
Hospira	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088330-001	May 17, 1984		DISCN	No	No
Hospira	KETOROLAC TROMETHAMINE	ketorolac tromethamine	INJECTABLE;INJECTION	074802-001	Jun 5, 1997	AP	RX	No	Yes
Hospira	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	070252-001	Jan 16, 1987		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	021038-002	Mar 13, 2013	4,910,214*PED
Hospira	BRETYLOL	bretylium tosylate	INJECTABLE;INJECTION	017954-001	Approved Prior to Jan 1, 1982	RE29618
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	4,910,214*PED
Hospira	TRACRIUM PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	018831-001	Nov 23, 1983	4,179,507
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	6,716,867*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-001	Dec 17, 1999	4,910,214*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-001	Dec 17, 1999	5,344,840

Paragraph IV (Patent) Challenges for HOSPIRA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Injection	4 mcg/mL, 50 mL and 100 mL vials		2013-12-26

International Patents for Hospira Drugs

Country	Patent Number	Estimated Expiration
Cyprus	1120521
European Patent Office	2895187
European Patent Office	3345599
Mexico	2013003629
Morocco	37956
Taiwan	I593409
Denmark	2648520

Supplementary Protection Certificates for Hospira Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
1532149	8/2012	Austria		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1255752	C 2008 002	Romania		PRODUCT NAME: N-[2-(DIETILAMINO)ETIL]-5-[(Z)-(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL]-2,4-DIMETIL-1H-PIROL-3-CAROXAMIDA - SUNITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC,INCLUSIV A SARII L-MALAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/06/347/001, RO EU/1/06/347/002, RO EU/1/06/347/003; DATE OF NATIONAL AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003; DATE OF FIRST AUTHORISATION IN EEA: 20060719
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1425001	SPC/GB14/034	United Kingdom		PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
0961612	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710

Similar Applicant Names

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

• Hospira
• Hospira Inc
• Hospira Worldwide