Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Merck
Express Scripts
McKesson
Baxter

Last Updated: October 20, 2019

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Hospira Company Profile

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Summary for Hospira

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 Inc CEFOTAXIME SODIUM cefotaxime sodium INJECTABLE;INJECTION 065290-003 Aug 11, 2006 AP RX No No   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes 9,320,712*PED   Start Trial Y   Start Trial
Hospira IOPAMIDOL iopamidol INJECTABLE;INJECTION 074734-001 Dec 10, 1996 DISCN No No   Start Trial   Start Trial
Hospira PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 083838-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Hospira TAZICEF ceftazidime INJECTABLE;INJECTION 064032-002 Oct 31, 1993 AP RX No No   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 6,716,867*PED   Start Trial
Hospira BRETYLOL bretylium tosylate INJECTABLE;INJECTION 017954-001 Approved Prior to Jan 1, 1982 RE29618   Start Trial
Hospira TRACRIUM PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 018831-001 Nov 23, 1983 4,179,507   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 4,910,214*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for HOSPIRA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 4 mcg/mL, 50 mL and 100 mL vials ➤ Subscribe 2013-12-26
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Injection 100 mcg/mL ➤ Subscribe 2009-04-08
➤ Subscribe Injection 4 mcg/mL, 20 mL vials ➤ Subscribe 2015-09-30
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16

Supplementary Protection Certificates for Hospira Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0230893 C980024 Netherlands   Start Trial PRODUCT NAME: GADOBEENZUUR,DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN ALKA- LIMETAAL, AARDALKALIMETAAL, OF BASISCH GEPROTONEERD AMINOZUUR OF VAN EEN ALKYLAMMONIUM-, ALKANOLAMMONIUM- OF POLYHYDROXYAL- KYLAMMONIUMZOUT, IN HET BIJZONDER DIMEGLUMINI GADOBENAS; NAT. REGISTRATION NO/DATE: RVG 22324 19980706; FIRST REGISTRATION: GB PL 06099/0006 19970722
0641330 SPC/GB04/034 United Kingdom   Start Trial PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
0933372 SPC/GB08/018 United Kingdom   Start Trial PRODUCT 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
2957286 CA 2018 00043 Denmark   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1480644 16C1019 France   Start Trial PRODUCT NAME: ASSOCIATION OU MELANGE PHARMACEUTIQUE RENFERMANT EN TANT QU'INGREDIENTS ACTIFS:(1) LA CEFTAZIDIME OU UN DES SES SELS ET (2) L'AVIBACTAM OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/16/1109 20160628
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Harvard Business School
Colorcon
Johnson and Johnson
Mallinckrodt

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