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Cipla
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Queensland Health
Healthtrust
Teva
QuintilesIMS
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Generated: September 18, 2018

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Ezetimibe; simvastatin - Generic Drug Details

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What are the generic drug sources for ezetimibe; simvastatin and what is the scope of ezetimibe; simvastatin freedom to operate?

Ezetimibe; simvastatin is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms Inc, Dr Reddys Labs Sa, Watson Labs Inc, and Msd Intl, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for ezetimibe; simvastatin. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Tentative approvals for EZETIMIBE; SIMVASTATIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial10MG; 80MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial10MG; 40MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial10MG; 20MGTABLET; ORAL

US Patents and Regulatory Information for ezetimibe; simvastatin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-002 Nov 21, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 202968-001 Apr 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-003 Nov 21, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-001 Apr 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-004 Apr 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-002 Apr 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ezetimibe; simvastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-002 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Harvard Business School
Cipla
Colorcon
Queensland Health
Healthtrust
Teva
QuintilesIMS
Medtronic

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