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Last Updated: March 30, 2020

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Upsher Smith Labs Company Profile


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

UPSHER SMITH LABS has ninety-five approved drugs.

There are seventeen US patents protecting UPSHER SMITH LABS drugs.

There are seventy patent family members on UPSHER SMITH LABS drugs in seventeen countries and forty-four supplementary protection certificates in nine countries.

Summary for Upsher Smith Labs
International Patents:70
US Patents:17
Tradenames:64
Ingredients:59
NDAs:95

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 ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075871-003 Apr 22, 2009 DISCN No No   Start Trial   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 RX Yes No 8,652,527   Start Trial Y   Start Trial
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 085088-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Upsher Smith Labs ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 076116-001 Sep 19, 2001 DISCN No No   Start Trial   Start Trial
Upsher Smith Labs TOPIRAMATE topiramate TABLET;ORAL 078499-003 Jan 7, 2010 AB RX No No   Start Trial   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 BC RX Yes No 8,889,190   Start Trial Y   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 BC RX Yes No 10,363,224   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
Paragraph IV (Patent) Challenges for UPSHER SMITH LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Nasal Spray 200 IU/spray ➤ Subscribe 2006-03-29
➤ Subscribe Extended-release Capsules 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg ➤ Subscribe 2015-12-24

Supplementary Protection Certificates for Upsher Smith Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C300528 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0637297 C300054 Netherlands   Start Trial PRODUCT NAME: BEXAROTENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVER- BINDING MET DE FORMULE R9OH, WAARIN R9 EEN; NAT. REGISTRATION NO/DATE: EU/1/01/178/001 20010329; FIRST REGISTRATION: EU/1/01/178/001 20010329
0443983 C300445 Netherlands   Start Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0733366 SPC/GB98/031 United Kingdom   Start Trial PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0253310 SZ 16/1996 Austria   Start Trial PRODUCT NAME: LOSARTAN-KALIUM
1175904 2007C/048 Belgium   Start Trial PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0678503 C300499 Netherlands   Start Trial PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
McKinsey
Moodys
Johnson and Johnson
Mallinckrodt

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 verification 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.