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Last Updated: November 2, 2024

Amlodipine besylate; valsartan - Generic Drug Details


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Recent Clinical Trials for amlodipine besylate; valsartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
CJ HealthCare CorporationPhase 1

See all amlodipine besylate; valsartan clinical trials

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; VALSARTAN
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 amlodipine besylate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090245-003 Mar 30, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090245-004 Mar 30, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202377-001 Mar 30, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 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 amlodipine besylate; valsartan

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

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