Hospira Company Profile

What is the competitive landscape for HOSPIRA

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-one patent family members on HOSPIRA drugs in thirty-nine countries and four hundred and twenty-three supplementary protection certificates in sixteen countries.

Summary for Hospira

International Patents:	71
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	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071166-001	Jun 16, 1988		DISCN	No	No
Hospira	HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	018916-011	Jun 23, 1989	AP	RX	Yes	Yes
Hospira	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%	heparin sodium	INJECTABLE;INJECTION	018911-004	Jan 30, 1985		DISCN	No	No
Hospira	PANCURONIUM BROMIDE	pancuronium bromide	INJECTABLE;INJECTION	072320-001	Jan 19, 1989		DISCN	No	No
Hospira	PARICALCITOL	paricalcitol	SOLUTION;INTRAVENOUS	201657-001	Oct 21, 2014		DISCN	No	No
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes

Expired US Patents for Hospira

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	4,910,214*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	6,716,867*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	4,910,214*PED
Hospira	TRACRIUM PRESERVATIVE FREE	atracurium besylate	INJECTABLE;INJECTION	018831-001	Nov 23, 1983	4,179,507

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

International Patents for Hospira Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3345599
Malaysia	188598
New Zealand	741342
South Africa	201502310
Spain	2671749
World Intellectual Property Organization (WIPO)	2014041425

Supplementary Protection Certificates for Hospira Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
3225249	CA 2019 00023	Denmark		PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313

Similar Applicant Names

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

• Hospira
• Hospira Inc
• Hospira Worldwide

Pharmaceutical Competitive Landscape Analysis: HOSPIRA – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Hospira emerged as a significant player, known for its specialty injectable pharmaceuticals and medical devices. This analysis delves into Hospira's market position, strengths, and strategic insights, providing valuable information for industry professionals seeking to understand the competitive landscape.

Hospira's Market Position

Hospira, before its acquisition by Pfizer in 2015, held a prominent position in the pharmaceutical industry. The company was recognized as:

1. The world's largest producer of generic injectable pharmaceuticals[1].
2. A leading provider of injectable drugs and infusion technologies[9].
3. A global leader in biosimilars[9].

These positions underscore Hospira's significant market presence and its importance in the pharmaceutical landscape.

Core Business Areas

Hospira's business was primarily focused on two key areas:

Specialty Injectable Pharmaceuticals (SIP)

Specialty Injectable Pharmaceuticals formed the backbone of Hospira's operations, accounting for 68% of the company's sales[6]. This segment included:

• Generic injectables
• Proprietary specialty injectables
• Biosimilars (in certain markets)

The SIP segment positioned Hospira as a crucial player in the injectable pharmaceuticals market, which was estimated to reach $70 billion by 2020[7].

Medical Devices

While less prominent than its pharmaceutical business, Hospira's medical device segment was still significant:

• It included medication management systems (MMS) such as infusion pumps and safety software[5].
• This segment represented less than 20% of Hospira's sales[6].

Hospira's Strengths

Hospira's market position was built on several key strengths:

1. Product Portfolio

Hospira boasted a broad and diverse product portfolio:

• A wide range of generic injectable pharmaceuticals[1].
• Advanced delivery systems for medications[5].
• Medication management systems, including infusion pumps and safety software[5].

This diverse portfolio allowed Hospira to cater to various healthcare needs and maintain a strong market presence.

2. Manufacturing Capabilities

Hospira's manufacturing capabilities were a significant strength:

• The company had state-of-the-art facilities for producing sterile injectables across multiple presentations (e.g., vials, pre-filled syringes, bags)[3].
• These capabilities positioned Hospira as a reliable supplier in the pharmaceutical industry.

3. Biosimilars Expertise

Hospira was at the forefront of the emerging biosimilars market:

• The company had significant experience in developing and manufacturing recombinant proteins[3].
• It had already launched biosimilar Remicade in Europe and was preparing to launch biosimilar Epogen in the U.S.[6].

This expertise in biosimilars positioned Hospira well in a market estimated to reach $20 billion by 2020[7].

4. Global Presence

While Hospira's operations were primarily concentrated in the Americas (80% of sales)[6], the company had a growing international presence:

• It had operations in Europe, Middle East, and Africa (EMEA) as well as Asia Pacific (APAC) regions[5].
• This global footprint provided opportunities for expansion and growth.

Strategic Insights

Hospira's strategic approach focused on several key areas:

1. Investment in Growth

Hospira consistently invested in growth initiatives:

• Increased R&D pipeline investment[5].
• Accelerated new product introductions, particularly in Medication Management Systems and Specialty Injectable Pharmaceuticals[5].
• Pursued international expansion[5].

2. Margin Improvement

Alongside growth initiatives, Hospira focused on improving its margins:

• Exited low-margin businesses[5].
• Launched manufacturing optimization initiatives[5].

3. Acquisitions and Alliances

Hospira actively pursued strategic acquisitions and alliances to strengthen its market position:

• Acquired Mayne Pharma Ltd. in 2007 for $2.1 billion, enhancing its specialty injectable pharmaceuticals business[1].
• Formed alliances to build its SIP portfolio outside the U.S.[5].

4. Focus on Biosimilars

Recognizing the potential of the biosimilars market, Hospira invested heavily in this area:

• Developed a significant pipeline of biosimilar products[3].
• Partnered with Celltrion to accelerate growth in the biosimilars field[6].

"The Pfizer-Hospira combination is an excellent strategic fit, presenting a unique opportunity to leverage the complementary strengths of our robust portfolios and rich pipelines," said F. Michael Ball, Chief Executive Officer, Hospira[7].

Competitive Dynamics

Hospira operated in a highly competitive pharmaceutical landscape:

Market Concentration

The generic injectable pharmaceuticals market, Hospira's primary focus, was characterized by a limited number of players[6]. This concentration led to:

• Stronger pricing power compared to the typical small molecule generic market[6].
• Better returns on investment[6].

Key Competitors

While specific competitor information is limited in the provided sources, it's worth noting that Hospira competed with other major pharmaceutical companies in the injectable and biosimilar markets.

Recent Strategic Actions

The most significant strategic action involving Hospira was its acquisition by Pfizer in 2015:

• Pfizer acquired Hospira for approximately $17 billion[1].
• This acquisition strengthened Pfizer's position in the sterile injectables and biosimilars markets[7].

Impact of Pfizer Acquisition

The acquisition of Hospira by Pfizer in 2015 had significant implications:

1. Enhanced Global Reach

Pfizer's global presence provided opportunities to expand Hospira's product reach:

• Hospira's products gained access to Pfizer's global distribution network[6].
• This expanded reach was expected to drive stronger growth prospects for Hospira's products[6].

2. Strengthened Manufacturing Capabilities

The acquisition addressed some of Hospira's manufacturing challenges:

• Pfizer's global manufacturing capabilities were expected to strengthen the competitive positioning of Hospira's products[6].
• This was particularly important given Hospira's history of manufacturing issues[6].

3. Biosimilars Synergy

The combination of Hospira and Pfizer created a powerful force in the biosimilars market:

• Hospira's biosimilars portfolio and pipeline complemented Pfizer's efforts in this emerging field[6].
• The combined entity was positioned to be a leading player in the growing biosimilars market[7].

4. Sterile Injectables Leadership

The acquisition created a leading global sterile injectables business:

• Hospira's broad generic sterile injectables product line was combined with Pfizer's branded sterile injectables[7].
• This combination reinforced Pfizer's growth strategy in the off-patent sterile injectables marketplace[7].

Key Takeaways

1. Hospira was a leading player in the specialty injectable pharmaceuticals and medical devices markets before its acquisition by Pfizer.

2. The company's strengths included a diverse product portfolio, strong manufacturing capabilities, expertise in biosimilars, and a growing global presence.

3. Hospira's strategic focus was on growth investment, margin improvement, strategic acquisitions and alliances, and biosimilars development.

4. The acquisition by Pfizer in 2015 significantly enhanced Hospira's global reach and manufacturing capabilities, while creating synergies in the biosimilars and sterile injectables markets.

5. The combined Pfizer-Hospira entity is well-positioned to be a leader in the growing markets for sterile injectables and biosimilars.

FAQs

1. What was Hospira's main business focus? Hospira's main focus was on specialty injectable pharmaceuticals, which accounted for 68% of its sales. The company was also involved in medical devices, particularly medication management systems.

2. How did the Pfizer acquisition impact Hospira's market position? The acquisition significantly enhanced Hospira's global reach by leveraging Pfizer's worldwide distribution network. It also strengthened Hospira's manufacturing capabilities and created synergies in the biosimilars and sterile injectables markets.

3. What were Hospira's key strengths in the pharmaceutical market? Hospira's key strengths included its diverse product portfolio, advanced manufacturing capabilities, expertise in biosimilars, and growing international presence.

4. How significant was Hospira's biosimilars business? Hospira was considered a global leader in biosimilars, with marketed products in Europe and a robust pipeline. The biosimilars market was estimated to reach $20 billion by 2020, making it a significant growth area for the company.

5. What was the rationale behind Pfizer's acquisition of Hospira? Pfizer acquired Hospira to strengthen its position in the sterile injectables and biosimilars markets. The acquisition was seen as strategically complementary, adding a growing revenue stream and a platform for growth to Pfizer's Global Established Pharmaceutical business.

Sources cited:

1. https://en.wikipedia.org/wiki/Hospira
2. https://s21.q4cdn.com/317678438/files/doc_presentations/HospiraAnnouncement020515FINAL.pdf
3. http://media.corporate-ir.net/media_files/irol/17/175550/032008_Hospira_Overview_Presentation.pdf
4. https://www.morningstar.com/stocks/pfizers-acquisition-hospira-strengthens-its-moat-fair-price
5. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-acquire-hospira
6. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-hospira