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-nine 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 three supplementary protection certificates in seventeen countries.
Summary for Sandoz
International Patents: | 103 |
US Patents: | 9 |
Tradenames: | 322 |
Ingredients: | 300 |
NDAs: | 489 |
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 | BUTABARBITAL SODIUM | butabarbital sodium | TABLET;ORAL | 085934-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Sandoz | THEOPHYLLINE | theophylline | CAPSULE, EXTENDED RELEASE;ORAL | 087462-001 | May 11, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Sandoz | METOLAZONE | metolazone | TABLET;ORAL | 076466-002 | Dec 19, 2003 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | CAPSULE;ORAL | 071293-001 | Feb 18, 1987 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212600-001 | Jun 13, 2022 | 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 |
>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 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 |
➤ Subscribe | Extended-release Capsule | 30 mg | ➤ Subscribe | 2010-12-15 |
➤ Subscribe | Ophthalmic Solution | 0.00% | ➤ Subscribe | 2009-02-19 |
International Patents for Sandoz Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Taiwan | I345977 | ⤷ Try a Trial |
South Africa | 200901164 | ⤷ Try a Trial |
Australia | 2004271731 | ⤷ Try a Trial |
Uruguay | 30605 | ⤷ Try a Trial |
South Korea | 20090058567 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Sandoz Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2782584 | C202130068 | Spain | ⤷ Try a Trial | 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 |
0174726 | 93C0021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LANSOPRAZOLE; NAT. REG.: 150 S 539 F 4 19921119; FIRST REG.: FR 333 412.1 19901211 |
0247633 | 97C0118 | France | ⤷ Try a Trial | PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107 |
0503785 | C300486 | Netherlands | ⤷ Try a Trial | 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 |
0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.