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Last Updated: May 30, 2023

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 eighteen US patents protecting UPSHER SMITH LABS drugs. There is one tentative approval on UPSHER SMITH LABS drugs.

There are one hundred and five patent family members on UPSHER SMITH LABS drugs in twenty-seven countries and seventy-six supplementary protection certificates in twelve countries.

Summary for Upsher Smith Labs
International Patents:105
US Patents:18
Tradenames:71
Ingredients:64
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 ORVATEN midodrine hydrochloride TABLET;ORAL 076725-002 Nov 3, 2004 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 209251-004 Jul 9, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784-003 Oct 24, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 AB2 RX Yes No 8,889,190 ⤷  Try a Trial Y ⤷  Try a Trial
Upsher Smith Labs FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784-002 Oct 24, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs LAMIVUDINE lamivudine TABLET;ORAL 206974-001 Nov 21, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 083215-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a 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 Upsher Smith Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE43580 ⤷  Try a Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 6,440,392 ⤷  Try a Trial
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE40812 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
0316633 99C0012 Belgium ⤷  Try a Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
0350733 SPC/GB03/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
1507558 12C0033 France ⤷  Try a Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
1631293 300683 Netherlands ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
0733366 SZ 25/1998 Austria ⤷  Try a Trial PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
0113964 97C0037 Belgium ⤷  Try a Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
1499331 SPC/GB13/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
>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:

Merck
Colorcon
McKinsey
Moodys
Johnson and Johnson
Mallinckrodt

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