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Last Updated: May 25, 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 TREPROSTINIL treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 203649-003 Nov 30, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up
Sandoz WESTADONE methadone hydrochloride TABLET, EFFERVESCENT;ORAL 017108-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sandoz PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040593-002 Nov 8, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sandoz RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-005 Oct 27, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Sandoz FAMOTIDINE famotidine TABLET;ORAL 075793-001 Apr 16, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sandoz GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077589-002 Jun 22, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up
Sandoz MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 076175-001 Feb 20, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up
>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 FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 6,635,284 ⤷  Sign Up
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 5,344,658*PED ⤷  Sign Up
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-003 Oct 28, 1994 4,814,168 ⤷  Sign Up
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 5,656,286 ⤷  Sign Up
Sandoz TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592-001 Aug 18, 1988 5,149,694 ⤷  Sign Up
Sandoz CIPRO HC ciprofloxacin hydrochloride; hydrocortisone SUSPENSION/DROPS;OTIC 020805-001 Feb 10, 1998 4,670,444*PED ⤷  Sign Up
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-001 Oct 28, 1994 4,814,168 ⤷  Sign Up
>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 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
➤ 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

Supplementary Protection Certificates for Sandoz Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 9890027-7 Sweden ⤷  Sign Up PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
1746976 1790033-3 Sweden ⤷  Sign Up PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
0521471 0391023-9 Sweden ⤷  Sign Up PRODUCT NAME: ROSUVASTATIN
0122232 2004C/008 Belgium ⤷  Sign Up PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
2582683 2019008 Norway ⤷  Sign Up PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904
0454511 SPC/GB98/037 United Kingdom ⤷  Sign Up PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
0480717 SPC/GB98/025 United Kingdom ⤷  Sign Up PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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