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 seventy-five 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: | 314 |
| Ingredients: | 292 |
| NDAs: | 475 |
| 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 | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 078679-007 | Dec 14, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | METHYLDOPA AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; methyldopa | TABLET;ORAL | 070829-001 | Mar 9, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 203939-001 | Dec 8, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | CAPSULE;ORAL | 077469-002 | Nov 17, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz | BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 203654-001 | Jul 26, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET;ORAL | 079230-002 | Dec 31, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Sandoz Inc | AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 065098-002 | Dec 16, 2002 | AB | RX | 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 | HYCAMTIN | topotecan hydrochloride | CAPSULE;ORAL | 020981-002 | Oct 11, 2007 | 5,004,758*PED | ⤷ Sign Up |
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | 5,578,628*PED | ⤷ Sign Up |
| Sandoz | HYCAMTIN | topotecan hydrochloride | INJECTABLE;INJECTION | 020671-001 | May 28, 1996 | 5,004,758*PED | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | 5,908,850 | ⤷ Sign Up |
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | 5,837,284 | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-004 | Oct 28, 1994 | 5,300,291 | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | 5,908,850 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for SANDOZ Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200603508 | ⤷ Sign Up |
| South Africa | 200901164 | ⤷ Sign Up |
| Taiwan | 200522969 | ⤷ Sign Up |
| Malaysia | 141763 | ⤷ Sign Up |
| Taiwan | I394564 | ⤷ Sign Up |
| Russian Federation | 2006120422 | ⤷ Sign Up |
| Hong Kong | 1126419 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SANDOZ Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | SPC/GB11/013 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 0275821 | SPC/GB01/039 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128 |
| 0429987 | 99C0021 | Belgium | ⤷ Sign Up | PRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223 |
| 2217577 | 1990005-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF LESINURAD OR A PHARMACEUTICA LLY ACCEPTABLE SALT THEREOF AND ALLOPURINOL; REG. NO/DATE: EU/18/1300 20180827 |
| 1412357 | C 2008 016 | Romania | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
| 0503785 | C300486 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 |
| 0122232 | 2004C/008 | Belgium | ⤷ Sign Up | PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316 |
| >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.
