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Last Updated: December 22, 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 SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 202825-003 Nov 7, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare CLOZAPINE clozapine TABLET;ORAL 202873-002 Nov 25, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride SOLUTION;INTRAVENOUS 209604-001 Aug 3, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 209281-001 Feb 7, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 202446-002 Jun 4, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 204022-001 Feb 28, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe
>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
1427415 C 2011 008 Romania ⤷  Subscribe PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518
0219829 06C0029 France ⤷  Subscribe PRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529
1203761 05C0029 France ⤷  Subscribe PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
0720599 122004000026 Germany ⤷  Subscribe PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
1427415 11C0042 France ⤷  Subscribe PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520
2217577 300970 Netherlands ⤷  Subscribe PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1300 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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