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Last Updated: April 27, 2024

Upsher Smith Company Profile


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Summary for Upsher Smith
International Patents:17
US Patents:8
Tradenames:74
Ingredients:68
NDAs:97

Drugs and US Patents for Upsher Smith

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 MORPHINE SULFATE morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 202104-002 Jun 3, 2013 RX No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Try a Trial Y ⤷  Try a Trial
Upsher Smith Labs HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET;ORAL 085088-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs MIRTAZAPINE mirtazapine TABLET;ORAL 076189-002 Jun 19, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784-004 Oct 24, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 AB2 RX Yes No 8,652,527 ⤷  Try a Trial Y ⤷  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

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 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 Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0473687 SPC/GB98/030 United Kingdom ⤷  Try a Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0637297 SPC/GB01/041 United Kingdom ⤷  Try a Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB01/041 GRANTED TO EISAI R + D MANAGEMENT., LTD. IN RESPECT OF THE PRODUCT BEXAROTENE (4-(1-(3, 5, 5, 8, 8-PENTAMETHYL-5, 6, 7, 8-TETRAHYDRO-2-NAPHTHALENYL)VINYL)BENZOIC ACID), WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 6469 DATED 15/05/2013 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 01/04/2016.
1519731 C300740 Netherlands ⤷  Try a Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0480717 SPC/GB98/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
2380576 2020/043 Ireland ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
0454511 24/1998 Austria ⤷  Try a Trial PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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