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Last Updated: July 19, 2024

SUN PHARM Company Profile


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Summary for SUN PHARM

Drugs and US Patents for SUN PHARM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc REPAGLINIDE repaglinide TABLET;ORAL 077571-002 Jul 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up
Sun Pharm AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078738-001 Jun 21, 2010 AT RX No No ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd SIMVASTATIN simvastatin TABLET;ORAL 076285-005 Jun 23, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 077974-003 Jul 9, 2007 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 SUN PHARM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-005 Aug 15, 2014 8,367,102 ⤷  Sign Up
Sun Pharm Industries BACTRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017560-001 Approved Prior to Jan 1, 1982 RE28636 ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-003 May 25, 2012 9,089,534 ⤷  Sign Up
Sun Pharm Inds Inc ABSORICA isotretinoin CAPSULE;ORAL 021951-004 May 25, 2012 9,089,534 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SUN PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Capsules 20 mg ➤ Subscribe 2013-01-07
➤ Subscribe Capsules 25 mg ➤ Subscribe 2016-05-16
➤ Subscribe Capsules 35 mg ➤ Subscribe 2015-11-25
➤ Subscribe Tablets 125 mg ➤ Subscribe 2018-07-23
➤ Subscribe Capsules 20 mg ➤ Subscribe 2013-06-19
➤ Subscribe Capsules 30 mg and 40 mg ➤ Subscribe 2012-12-31

Supplementary Protection Certificates for SUN PHARM Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1602370 SPC/GB09/024 United Kingdom ⤷  Sign Up PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
2435024 301102 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0136011 2000C/027 Belgium ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0984957 122012000051 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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