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Last Updated: June 10, 2024

ACCORD Company Profile


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Summary for ACCORD

Drugs and US Patents for ACCORD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare TOPIRAMATE topiramate TABLET;ORAL 076311-001 Mar 27, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare SIMVASTATIN simvastatin TABLET;ORAL 078155-005 Apr 5, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 200044-003 Feb 13, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 202152-005 Mar 27, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 202555-001 Aug 23, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 202556-002 Sep 24, 2012 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
Paragraph IV (Patent) Challenges for ACCORD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for ACCORD Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 132014902271575 Italy ⤷  Sign Up PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
2316456 17C1058 France ⤷  Sign Up PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
1189916 C01189916/01 Switzerland ⤷  Sign Up PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1853250 2014C/037 Belgium ⤷  Sign Up PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
0720599 92545 Luxembourg ⤷  Sign Up PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0265685 C980030 Netherlands ⤷  Sign Up PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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