Upsher Smith Company Profile

What is the competitive landscape for UPSHER SMITH, and when can generic versions of UPSHER SMITH drugs launch?

UPSHER SMITH has ninety-seven approved drugs.

There are eight US patents protecting UPSHER SMITH drugs.

There are seventeen patent family members on UPSHER SMITH drugs in ten countries and one hundred and forty-two supplementary protection certificates in fourteen countries.

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	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014	AB2	RX	Yes	Yes	10,363,224
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-001	Nov 3, 2004	AB	RX	No	No
Upsher Smith Labs	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	075566-002	Mar 8, 2004		DISCN	No	No
Upsher Smith Labs	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078311-002	Mar 6, 2009		DISCN	No	No
Upsher Smith Labs	PACERONE	amiodarone hydrochloride	TABLET;ORAL	075135-002	Apr 12, 2005	AB	RX	No	No
Upsher Smith Labs	PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212744-001	Jun 25, 2020	AB	RX	No	No
Upsher Smith Labs	IRBESARTAN	irbesartan	TABLET;ORAL	200461-003	Sep 27, 2012		DISCN	No	No

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
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 drugs

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

International Patents for Upsher Smith Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015089289
European Patent Office	2968177
European Patent Office	3079703
South Korea	20160124930
Israel	241053
Hong Kong	1223852
Singapore	11201604788U

Supplementary Protection Certificates for Upsher Smith Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0780390	PA2004012,C0780390	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-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
0392059	2002C/035	Belgium		PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0350733	C300111	Netherlands		PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621
1409467	122015000051	Germany		PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;

Similar Applicant Names

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

• Upsher Smith
• Upsher Smith Labs