Upsher Smith Labs Company Profile

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UPSHER SMITH LABS has eighty-nine approved drugs.

There are eight US patents protecting UPSHER SMITH LABS drugs.

There are seventeen patent family members on UPSHER SMITH LABS drugs in ten countries and one hundred and thirty-four supplementary protection certificates in thirteen countries.

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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	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-003	Oct 2, 2003	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	202104-003	Jun 3, 2013		RX	No	No		⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014	AB2	RX	Yes	No	8,889,190	⤷ Sign Up	Y			⤷ Sign Up
Upsher Smith Labs	ZALEPLON	zaleplon	CAPSULE;ORAL	078095-002	Jun 6, 2008		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	IRBESARTAN	irbesartan	TABLET;ORAL	200461-003	Sep 27, 2012		DISCN	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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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	6,440,392	⤷ Sign Up
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE43580	⤷ Sign Up
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE40812	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713823	1490064-1	Sweden	⤷ Sign Up	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0733366	SPC/GB98/031	United Kingdom	⤷ Sign Up	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
1713823	92595	Luxembourg	⤷ Sign Up	PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
2203431	1590018-6	Sweden	⤷ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1519731	C300740	Netherlands	⤷ Sign Up	PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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