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Last Updated: May 17, 2022

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-two approved drugs.

There are sixteen US patents protecting UPSHER SMITH LABS drugs.

There are ninety-three patent family members on UPSHER SMITH LABS drugs in twenty-one countries and fifty-five supplementary protection certificates in eleven countries.

Summary for Upsher Smith Labs
International Patents:93
US Patents:16
Tradenames:68
Ingredients:61
NDAs:92

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 AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 212654-005 Sep 29, 2021 AB RX No No See Plans and Pricing See Plans and Pricing
Upsher Smith Labs CLOBAZAM clobazam TABLET;ORAL 209687-002 Oct 22, 2018 AB RX No No See Plans and Pricing See Plans and Pricing
Upsher Smith Labs VOGELXO testosterone GEL;TRANSDERMAL 204399-002 Jun 4, 2014 AB2 RX No No 9,662,340 See Plans and Pricing Y See Plans and Pricing
Upsher Smith Labs CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 084920-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing
Upsher Smith Labs KLOR-CON M10 potassium chloride TABLET, EXTENDED RELEASE;ORAL 074726-002 Aug 9, 2000 AB1 RX No No See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 6,440,392 See Plans and Pricing
Upsher Smith Labs FORTICAL calcitonin salmon recombinant SPRAY, METERED;NASAL 021406-001 Aug 12, 2005 RE40812 See Plans and Pricing
>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 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0600675 SPC/GB10/031 United Kingdom See Plans and Pricing PRODUCT NAME: SILODOSIN, OPTIONALLY IN A FORM OF A PHARMACEUTICAL ACCEPTABLE SALT; REGISTERED: UK EU/1/09/607/001-014 20100129; UK EU/1/09/608/001-014 20100129
1441735 2008/010 Ireland See Plans and Pricing PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1507558 2012/018 Ireland See Plans and Pricing 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
3141251 301099 Netherlands See Plans and Pricing PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
0503785 CA 2011 00026 Denmark See Plans and Pricing PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
>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
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