Last Updated: November 13, 2026

Upsher Smith Company Profile

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What is the competitive landscape for UPSHER SMITH

UPSHER SMITH has eighty-seven approved drugs.

There are eight US patents protecting UPSHER SMITH drugs.

Summary for Upsher Smith

US Patents:	8
Tradenames:	64
Ingredients:	59
NDAs:	87

Drugs and US Patents for Upsher Smith

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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	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	206484-002	Mar 24, 2017		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	218191-001	Feb 11, 2025	AB	RX	No	No		⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	MORPHINE SULFATE	morphine sulfate	TABLET;ORAL	210610-001	Jul 22, 2019	AB	RX	No	No		⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014	AB2	RX	Yes	No	8,889,190	⤷ Start Trial	Y			⤷ Start Trial
Upsher Smith Labs	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	084487-001	Apr 9, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075315-002	Jun 30, 2000		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Upsher Smith Labs	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076188-002	Oct 8, 2004		DISCN	No	No		⤷ 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

Expired US Patents for Upsher Smith

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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	⤷ Start Trial
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE43580	⤷ Start Trial
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE40812	⤷ Start 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

International Patents for Upsher Smith Drugs

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Country	Patent Number	Estimated Expiration
Canada	2857286	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2015089289	⤷ Start Trial
South Korea	20200010608	⤷ Start Trial
Hong Kong	1223852	⤷ Start Trial
South Korea	20200010608	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2014143380	⤷ Start Trial
South Korea	20160124930	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Upsher Smith Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	SPC/GB13/034	United Kingdom	⤷ Start 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
1441735	SPC/GB08/020	United Kingdom	⤷ Start Trial	PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1409467	244 4-2015	Slovakia	⤷ Start Trial	PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
2666774	CR 2020 00037	Denmark	⤷ Start Trial	PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0579826	02C0041	France	⤷ Start Trial	PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1713823	92595	Luxembourg	⤷ Start Trial	PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
1631293	92462	Luxembourg	⤷ Start Trial	PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
>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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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.