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Last Updated: June 2, 2020

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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 Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227-001 Jul 11, 2016 AT RX No No   Start Trial   Start Trial
Sandoz Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079171-004 Jul 19, 2016 AB RX No No   Start Trial   Start Trial
Sandoz ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078050-002 Aug 13, 2007 AB RX No No   Start Trial   Start Trial
Sandoz DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET;ORAL 072104-001 Jun 20, 1988 AB RX No No   Start Trial   Start Trial
Sandoz MEROPENEM meropenem INJECTABLE;INJECTION 091201-001 Mar 29, 2011 DISCN No No   Start Trial   Start Trial
Sandoz Inc REGONOL pyridostigmine bromide INJECTABLE;INJECTION 017398-001 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start 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 Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 4,342,783   Start Trial
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 5,196,404*PED   Start Trial
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 6,174,524*PED   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 4,311,708   Start Trial
Sandoz Inc BETOPTIC betaxolol hydrochloride SOLUTION/DROPS;OPHTHALMIC 019270-001 Aug 30, 1985 4,252,984   Start Trial
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-002 Oct 21, 1998 6,174,524*PED   Start 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 Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ 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
1631293 92462 Luxembourg   Start Trial PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
2582683 2019008 Norway   Start Trial PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904
0720599 C300688 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
1534313 92923 Luxembourg   Start Trial PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
0299602 SPC/GB96/040 United Kingdom   Start Trial PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0227494 95C0013 Belgium   Start Trial PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
>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.

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Colorcon
Boehringer Ingelheim
Merck
Mallinckrodt

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