SANDOZ Company Profile

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

SANDOZ has four hundred and seventy-four approved drugs.

There are nine US patents protecting SANDOZ drugs. There are thirty-two tentative approvals on SANDOZ drugs.

There are one hundred and three patent family members on SANDOZ drugs in thirty-four countries and five hundred and seven supplementary protection certificates in seventeen countries.

Summary for SANDOZ

International Patents:	103
US Patents:	9
Tradenames:	313
Ingredients:	291
NDAs:	474
Patent Litigation for SANDOZ:	See patent lawsuits for SANDOZ
PTAB Cases with SANDOZ as petitioner:	See PTAB cases with SANDOZ as petitioner

Drugs and US Patents for SANDOZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz Inc	TOPOTECAN	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200199-002	Feb 25, 2011		DISCN	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-006	Apr 11, 2006	AB	RX	Yes	Yes
Sandoz	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077446-001	Sep 27, 2012	AB	RX	No	No
Sandoz	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074162-002	Dec 21, 1993		DISCN	No	No
Sandoz	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	078167-001	Dec 26, 2007		DISCN	No	No
Sandoz	BUTABARBITAL SODIUM	butabarbital sodium	TABLET;ORAL	085938-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sandoz	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090107-001	Jul 1, 2011	AB	RX	No	No

Expired US Patents for SANDOZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999	5,656,286
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004	5,837,284
Sandoz	ZOFRAN PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	020007-003	Dec 10, 1993	5,578,628*PED
Sandoz	HYCAMTIN	topotecan hydrochloride	CAPSULE;ORAL	020981-001	Oct 11, 2007	5,004,758*PED
Sandoz	ZOFRAN	ondansetron hydrochloride	SOLUTION;ORAL	020605-001	Jan 24, 1997	5,578,628*PED
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-007	Apr 21, 2011	6,730,325
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-006	Aug 11, 2010	5,908,850

Paragraph IV (Patent) Challenges for SANDOZ drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsule	30 mg		2010-12-15
	Ophthalmic Solution	0.00%		2009-02-19
	Extended-release capsules	25 mg		2011-09-30
	Extended-release Tablets	80 mg		2007-03-15
	Extended-release Capsules	10 mg		2007-05-21
	Tablets	5 mg and 10 mg		2004-05-27
	Capsules	2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg		2004-06-09
	Ophthalmic Emulsion	0.05%		2014-05-01
	Oral Solution	2 mg/mL		2004-11-05
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Delayed-release Tablets	20 mg		2015-06-03
	Oral Solution	4 mg/5 mL		2004-12-20
	Extended-release Capsules	5mg, 10mg and 20 mg		2007-03-30
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29
	Extended-release Capsule	40 mg		2010-12-20
	Otic Suspension	0.3%/0.1%		2012-07-31
	Extended-release capsules	35 mg		2011-09-29
	Tablets	2.5 mg		2004-07-27
	Extended-release Capsules	20 mg, 30 mg and 40 mg		2006-08-21
	Capsules	5 mg/40 mg and 10 mg/40 mg		2006-11-17
	Capsules	1.5 mg, 3 mg, 4.5 mg and 6 mg		2004-04-21
	Transdermal System Extended-release	13.3 mg/24 hr		2013-01-22
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Extended-release Capsules	15 mg		2007-05-14
	For Injection	250 mg/vial		2009-09-01

International Patents for SANDOZ Drugs

Country	Patent Number	Estimated Expiration
Poland	2068822
Japan	2013234199
Colombia	5680461
Taiwan	200530250
Japan	4785970
European Patent Office	1429780
Tunisia	SN06084

Supplementary Protection Certificates for SANDOZ Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
3141251	C202130017	Spain		PRODUCT NAME: COMBINACION DE PRINCIPIOS ACTIVOS EN DOS DOSIS, EN LA QUE LA PRIMERA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, SULFATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO, Y LA SEGUNDA DOSIS CONSISTE EN LOS PRINCIPIOS ACTIVOS POLIETILENGLICOL, ACIDO ASCORBICO, ASCORBATO DE SODIO, CLORURO DE SODIO Y CLORURO DE POTASIO.; NATIONAL AUTHORISATION NUMBER: 82959-SE/H/1801/001/DC; DATE OF AUTHORISATION: 20180525; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): IS/1/17/083/01; DATE OF FIRST AUTHORISATION IN EEA: 20171016
2217577	CR 2019 00003	Denmark		PRODUCT NAME: ALLOPURINOL AND LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
0489070	22/2004	Austria		PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720

Similar Applicant Names

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

• Sandoz
• Sandoz Canada Inc
• Sandoz Inc