Upsher Smith Labs Company Profile

What is the competitive landscape for UPSHER SMITH LABS, and what generic alternatives to UPSHER SMITH LABS drugs are available?

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.

Summary for Upsher Smith Labs

International Patents:	17
US Patents:	8
Tradenames:	69
Ingredients:	63
NDAs:	89

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	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212744-003	Jun 25, 2020	AB	RX	No	No
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-004	Mar 11, 2014	AB2	RX	Yes	No	8,889,190		Y
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416-002	Oct 2, 2003	AB	RX	No	No
Upsher Smith Labs	OXANDROLONE	oxandrolone	TABLET;ORAL	078033-001	Mar 22, 2007		DISCN	No	No
Upsher Smith Labs	FOSINOPRIL SODIUM	fosinopril sodium	TABLET;ORAL	076188-002	Oct 8, 2004		DISCN	No	No
Upsher Smith Labs	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	091635-001	Apr 29, 2015		DISCN	No	No
Upsher Smith Labs	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	084487-001	Apr 9, 1982		DISCN	No	No

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
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	6,440,392
Upsher Smith Labs	FORTICAL	calcitonin salmon recombinant	SPRAY, METERED;NASAL	021406-001	Aug 12, 2005	RE40812

Paragraph IV (Patent) Challenges for UPSHER SMITH LABS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsules	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg		2015-12-24
	Nasal Spray	200 IU/spray		2006-03-29

International Patents for Upsher Smith Labs Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014143380
South Africa	201604587
South Korea	101674509
South Korea	20150132838
South Korea	20160124930
Canada	2857286
Hong Kong	1223852

Supplementary Protection Certificates for Upsher Smith Labs Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
1441735	08C0026	France		PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
0780390	PA2004012	Lithuania		PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-__ 1,4-DIHIDRO-8-METOKSI-7-[(4AS, 7AS)-OKTAHIDRO-6H-PIROLO[3,4-B]PIRIDIN_-6-IL]-4-OKSO-3-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Upsher Smith
• Upsher Smith Labs