Sandoz Company Profile
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What is the competitive landscape for SANDOZ, and what generic alternatives to SANDOZ drugs are available?
SANDOZ has four hundred and eighty-six approved drugs.
There are nine US patents protecting SANDOZ drugs. There are thirty-three 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 one supplementary protection certificates in seventeen countries.
Summary for Sandoz
| International Patents: | 103 |
| US Patents: | 9 |
| Tradenames: | 320 |
| Ingredients: | 298 |
| NDAs: | 486 |
| 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 | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090422-002 | Aug 13, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | GALANTAMINE HYDROBROMIDE | galantamine hydrobromide | TABLET;ORAL | 077589-003 | Jun 22, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | NAFCILLIN SODIUM | nafcillin sodium | INJECTABLE;INJECTION | 062527-001 | Aug 2, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | CAFERGOT | caffeine; ergotamine tartrate | TABLET;ORAL | 084294-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | AMOXICILLIN | amoxicillin | TABLET;ORAL | 065228-002 | Jul 13, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ISOPTO CARPINE | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 200890-003 | Jun 22, 2010 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 076969-003 | Mar 20, 2008 | 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 | 021802-007 | Apr 21, 2011 | 7,431,944 | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-003 | Nov 13, 2001 | 6,355,656 | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-003 | Nov 13, 2001 | 6,528,530 | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | 5,837,284 | ⤷ Sign Up |
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | 9,402,805 | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | 6,355,656 | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-001 | Dec 31, 1992 | 4,695,578*PED | ⤷ 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 |
International Patents for Sandoz Drugs
Supplementary Protection Certificates for Sandoz Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1280520 | C01280520/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012 |
| 0770388 | PA2009004 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
| 2782584 | C202130068 | Spain | ⤷ Sign Up | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
| 2435024 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
| 1304992 | 122013000081 | Germany | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322 |
| 2435025 | 2019C/532 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
| 1003503 | 30/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
