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Last Updated: May 8, 2024

Sandoz Company Profile


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Summary for Sandoz

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 GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078531-002 Apr 30, 2009 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 077948-003 Aug 19, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-009 May 3, 2002 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Sandoz QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 078679-002 Dec 14, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 203649-001 Nov 30, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a 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 Sandoz

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-002 Oct 28, 1994 5,300,291 ⤷  Try a Trial
Sandoz AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998 5,378,703*PED ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 6,335,031 ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 5,344,658*PED ⤷  Try a Trial
Sandoz FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001 6,528,530 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SANDOZ drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Oral Solution 4 mg/5 mL ➤ Subscribe 2004-12-20
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 2007-03-30
➤ Subscribe Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 2008-08-29
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 2010-12-20
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 2011-09-29
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 2004-07-27
➤ Subscribe Extended-release Capsules 20 mg, 30 mg and 40 mg ➤ Subscribe 2006-08-21
➤ Subscribe Capsules 5 mg/40 mg and 10 mg/40 mg ➤ Subscribe 2006-11-17
➤ Subscribe Capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg ➤ Subscribe 2004-04-21
➤ Subscribe Transdermal System Extended-release 13.3 mg/24 hr ➤ Subscribe 2013-01-22
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 2007-05-14
➤ Subscribe For Injection 250 mg/vial ➤ Subscribe 2009-09-01
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 2010-12-15
➤ Subscribe Ophthalmic Solution 0.00% ➤ Subscribe 2009-02-19
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 2011-09-30
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe 2007-03-15
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 2007-05-21
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-05-27
➤ Subscribe Capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg ➤ Subscribe 2004-06-09
➤ Subscribe Ophthalmic Emulsion 0.05% ➤ Subscribe 2014-05-01
➤ Subscribe Oral Solution 2 mg/mL ➤ Subscribe 2004-11-05

Supplementary Protection Certificates for Sandoz Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 PA2014022 Lithuania ⤷  Try a Trial PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1539166 2013C/064 Belgium ⤷  Try a Trial PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
0480717 C990009 Netherlands ⤷  Try a Trial PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
2316456 65/2017 Austria ⤷  Try a Trial PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330
1746976 300885 Netherlands ⤷  Try a Trial PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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