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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Boehringer Ingelheim
Federal Trade Commission
Merck
AstraZeneca
UBS
Johnson and Johnson
Citi

Generated: June 25, 2018

DrugPatentWatch Database Preview

EXFORGE Drug Profile

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When do Exforge patents expire, and when can generic versions of Exforge launch?

Exforge is a drug marketed by Novartis and is included in two NDAs. There are three patents protecting this drug and six Paragraph IV challenges.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

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

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Expired US Patents for EXFORGE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 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 021990-004 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for EXFORGE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m ➤ Subscribe 2009-09-14
➤ Subscribe Tablets 10 mg/12.5 mg/160 mg ➤ Subscribe 2009-10-22
➤ Subscribe Tablets 5 mg/320 mg ➤ Subscribe 2007-11-26
➤ Subscribe Tablets 10 mg/320 mg ➤ Subscribe 2007-11-09
➤ Subscribe Tablets 5 mg/160 mg ➤ Subscribe 2007-10-22
➤ Subscribe Tablets 10 mg/160 mg ➤ Subscribe 2007-10-01

Non-Orange Book US Patents for EXFORGE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,204,281 Method of treatment and pharmaceutical composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
US Army
Federal Trade Commission
Dow
Harvard Business School
Fish and Richardson
QuintilesIMS
Cipla

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