You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 27, 2024

EXFORGE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Paragraph IV (Patent) Challenges for EXFORGE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXFORGE Tablets amlodipine besylate; valsartan 5 mg/320 mg 021990 1 2007-11-26
EXFORGE Tablets amlodipine besylate; valsartan 10 mg/320 mg 021990 1 2007-11-09
EXFORGE Tablets amlodipine besylate; valsartan 5 mg/160 mg 021990 1 2007-10-22
EXFORGE Tablets amlodipine besylate; valsartan 10 mg/160 mg 021990 1 2007-10-01

US Patents and Regulatory Information for EXFORGE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 AB RX Yes No ⤷  Sign Up ⤷  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 EXFORGE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for EXFORGE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0443983 23/1997 Austria ⤷  Sign Up PRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513
0502314 SPC/GB11/010 United Kingdom ⤷  Sign Up PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0443983 C970001 Netherlands ⤷  Sign Up PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
1003503 05C0048 France ⤷  Sign Up PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0502314 C300478 Netherlands ⤷  Sign Up PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.