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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Fish and Richardson
Healthtrust
Accenture
Daiichi Sankyo
Express Scripts
Fuji
Queensland Health
Medtronic

Generated: November 18, 2018

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Shire Orphan Therap Company Profile

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

SHIRE ORPHAN THERAP has one approved drug.

There is one US patent protecting SHIRE ORPHAN THERAP drugs.

Summary for Shire Orphan Therap

Drugs and US Patents for Shire Orphan Therap

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Orphan Therap FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up
Shire Orphan Therap FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 RX Yes Yes 5,648,333 ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SHIRE ORPHAN THERAP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2015-08-25

Supplementary Protection Certificates for Shire Orphan Therap Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0359 Netherlands ➤ Sign Up 300359, 20091121, EXPIRES: 20141120
/2008 Austria ➤ Sign Up PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
C0002 France ➤ Sign Up PRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Teva
Argus Health
Accenture
Farmers Insurance
Merck
Deloitte
Cerilliant
Moodys

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