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Last Updated: November 2, 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 AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 202553-003 Apr 29, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare ARIPIPRAZOLE aripiprazole TABLET;ORAL 206251-006 Dec 7, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare CAPECITABINE capecitabine TABLET;ORAL 202593-002 Apr 23, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 202446-003 Jun 4, 2014 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 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 214347-001 Nov 22, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare Inc BUSULFAN busulfan INJECTABLE;INJECTION 210148-001 Feb 22, 2019 AP 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
1613288 SPC/GB11/045 United Kingdom ⤷  Sign Up PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
1381356 14C0010 France ⤷  Sign Up PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1667986 2013/021 Ireland ⤷  Sign Up PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1427415 PA2011012,C1427415 Lithuania ⤷  Sign Up PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518
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
0219829 SPC/GB06/034 United Kingdom ⤷  Sign Up PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
2785706 122020000046 Germany ⤷  Sign Up PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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