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Last Updated: April 19, 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 GRISEOFULVIN, ULTRAMICROSIZE griseofulvin, ultramicrosize TABLET;ORAL 202805-001 Dec 26, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065387-001 Mar 26, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz FLUMAZENIL flumazenil INJECTABLE;INJECTION 077071-001 May 3, 2005 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091022-004 Sep 28, 2012 AB4 RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz CLARITHROMYCIN clarithromycin FOR SUSPENSION;ORAL 065283-002 Sep 4, 2007 RX No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIMETIDINE cimetidine TABLET;ORAL 074250-002 Jun 29, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Sandoz ALPRAZOLAM alprazolam TABLET;ORAL 074112-001 Dec 29, 1995 AB 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 020323-001 Oct 28, 1994 5,300,291 ⤷  Try a Trial
Sandoz FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 6,255,325 ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 6,528,530 ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 6,335,031 ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 6,228,398 ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 5,837,284 ⤷  Try a Trial
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 6,355,656 ⤷  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 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
➤ 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

Supplementary Protection Certificates for Sandoz Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2012022 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
0193926 98C0038 Belgium ⤷  Try a Trial PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
1920764 PA2012017 Lithuania ⤷  Try a Trial PRODUCT NAME: TRAVOPROSTUM; NAT. REGISTRATION NO/DATE: LT 02/7821/3 20020402; FIRST REGISTRATION: EU/1/01/199/001 - EU/1/01/199/002 20011127
1602370 SPC/GB09/024 United Kingdom ⤷  Try a Trial PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
2785706 122020000046 Germany ⤷  Try a Trial PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
2498758 CR 2020 00017 Denmark ⤷  Try a Trial PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1534313 C 2015 055 Romania ⤷  Try a Trial PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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