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Express Scripts
Daiichi Sankyo
Colorcon
Moodys
Accenture
US Department of Justice
Healthtrust
McKinsey
Federal Trade Commission

Generated: February 17, 2019

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Upsher Smith Labs Company Profile

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Summary for Upsher Smith Labs
International Patents:22
US Patents:10
Tradenames:52
Ingredients:47
NDAs:71

Drugs and US Patents for Upsher Smith Labs

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 206484-003 Mar 24, 2017 AA RX No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs TOPIRAMATE topiramate TABLET;ORAL 078499-001 Jan 7, 2010 AB RX No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs AMOXAPINE amoxapine TABLET;ORAL 072943-001 Jun 28, 1991 DISCN No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 083561-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076189-001 Jun 19, 2003 DISCN No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076483-001 Apr 23, 2004 AB RX No No ➤ Sign Up ➤ Sign Up
Upsher Smith Labs EXEMESTANE exemestane TABLET;ORAL 209208-001 Jul 26, 2017 AB RX No No ➤ Sign Up ➤ 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 UPSHER SMITH LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg ➤ Subscribe 2015-12-24
➤ Subscribe Nasal Spray 200 IU/spray ➤ Subscribe 2006-03-29

Supplementary Protection Certificates for Upsher Smith Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0055 France ➤ Sign Up PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
C0048 France ➤ Sign Up PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
C0020 Belgium ➤ Sign Up PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902
C/GB08/020 United Kingdom ➤ Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
C/GB12/028 United Kingdom ➤ Sign Up PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
02C/035 Belgium ➤ Sign Up PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
12/018 Ireland ➤ Sign Up PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
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.

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Queensland Health
Farmers Insurance
Merck
Chubb
Cerilliant
QuintilesIMS
Covington
AstraZeneca

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