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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Citi
McKesson
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Argus Health
Teva
Daiichi Sankyo
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Generated: September 24, 2017

DrugPatentWatch Database Preview

Hospira Company Profile

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What is the competitive landscape for HOSPIRA, and what generic alternatives to HOSPIRA drugs are available?

HOSPIRA has five hundred and eight approved drugs.

There are seven US patents protecting HOSPIRA drugs on HOSPIRA drugs in the past three years. There are nine tentative approvals on HOSPIRA drugs.

There are sixty-six patent family members on HOSPIRA drugs in thirty-six countries.

Summary for Applicant: Hospira

Patents:7
Tradenames:328
Ingredients:201
NDAs:508
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
dobutamine hydrochloride
INJECTABLE;INJECTION020269-002Oct 19, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
TALWIN
pentazocine lactate
INJECTABLE;INJECTION016194-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Hospira
SORBITOL-MANNITOL IN PLASTIC CONTAINER
mannitol; sorbitol
SOLUTION;IRRIGATION017636-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
AMPICILLIN AND SULBACTAM
ampicillin sodium; sulbactam sodium
INJECTABLE;INJECTION090375-002Dec 21, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION200795-003Aug 4, 2011APRXYesYes► Subscribe► Subscribe► Subscribe
Hospira
MORPHINE SULFATE
morphine sulfate
INJECTABLE;INJECTION073509-001Sep 30, 1992APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira
SORBITOL-MANNITOL
mannitol; sorbitol
SOLUTION;IRRIGATION080224-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
DROPERIDOL
droperidol
INJECTABLE;INJECTION072272-001Aug 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
A-METHAPRED
methylprednisolone sodium succinate
INJECTABLE;INJECTION085853-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
VECURONIUM BROMIDE
vecuronium bromide
INJECTABLE;INJECTION075164-002Oct 21, 1999APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Hospira

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013► Subscribe► Subscribe
Hospira
BRETYLOL
bretylium tosylate
INJECTABLE;INJECTION017954-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Hospira
TRACRIUM PRESERVATIVE FREE
atracurium besylate
INJECTABLE;INJECTION018831-001Nov 23, 1983► Subscribe► Subscribe
Hospira Inc
NIPENT
pentostatin
INJECTABLE;INJECTION020122-001Oct 11, 1991► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999► Subscribe► Subscribe
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Paragraph IV activity for HOSPIRA drugs

Drugname Dosage Strength Tradename Submissiondate
dexmedetomidine
Injection 4 mcg/mL, 20 mL vials
PRECEDEX
9/30/2015
dexmedetomidine
Injection4 mcg/mL, 50 mL and 100 mL vials
PRECEDEX
12/26/2013
argatroban in sodium chloride
Injection1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
dexmedetomidine
Injection100 mcg/mL
PRECEDEX
4/8/2009
argatroban
Injection100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007

Non-Orange Book 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
8,436,033Methods of treatment using a dexmedetomidine premix formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Hospira Drugs

Country Document Number Estimated Expiration
Canada2806706► Subscribe
Bulgaria104797► Subscribe
Japan4606581► Subscribe
Japan5927680► Subscribe
Mexico2013003629► Subscribe
China1295473► Subscribe
Taiwan552136► Subscribe
Japan5990832► Subscribe
Brazil9909872► Subscribe
Norway20004931► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Hospira Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2015000111Germany► SubscribePRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
C0035France► SubscribePRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
C0042France► SubscribePRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
41/2009Austria► SubscribePRODUCT NAME: PACLITAXEL ALBUMIN
/2014Austria► SubscribePRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
0812Netherlands► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
90062-5Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
C0022France► SubscribePRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
AstraZeneca
Chinese Patent Office
Merck
Teva
Express Scripts
Farmers Insurance
Argus Health
US Army
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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