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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Covington
Dow
Daiichi Sankyo
UBS
Boehringer Ingelheim
Baxter
Johnson and Johnson

Generated: May 22, 2018

DrugPatentWatch Database Preview

Amlodipine besylate; valsartan - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; valsartan and what is the scope of amlodipine besylate; valsartan freedom to operate?

Amlodipine besylate; valsartan
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan Pharms Inc, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Novartis, and is included in ten NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate; valsartan. Fourteen suppliers are listed for this compound.

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
Invagen Pharms AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 205137-004 Sep 16, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 205137-001 Sep 16, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 206512-001 Apr 22, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
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 amlodipine besylate; valsartan

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 021990-004 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 021990-003 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for amlodipine besylate; valsartan

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:

Accenture
Queensland Health
UBS
Cerilliant
Colorcon
QuintilesIMS
Mallinckrodt
Federal Trade Commission
US Department of Justice

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