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Generated: April 22, 2019

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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, 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. Sixteen 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
Torrent AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202377-003 Mar 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 091235-004 Mar 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novel Labs Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202829-002 Mar 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
Alembic Pharms Ltd AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 202713-004 Apr 3, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090483-003 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 021990-004 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 021990-005 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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