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Generated: May 22, 2019

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Olanzapine - Generic Drug Details

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

Olanzapine is the generic ingredient in four branded drugs marketed by Luitpold, Sandoz Inc, Lilly, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma Pharms, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu Pharm Co Ltd, Sunshine Lake, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms Usa Inc, and Eli Lilly Co, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for olanzapine. Forty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for olanzapine
Generic filers with tentative approvals for OLANZAPINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunshine Lake OLANZAPINE olanzapine TABLET;ORAL 206238-003 Nov 19, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms OLANZAPINE olanzapine TABLET;ORAL 203333-003 Mar 15, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd OLANZAPINE olanzapine TABLET;ORAL 076255-004 Apr 23, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc OLANZAPINE olanzapine TABLET;ORAL 090459-001 Jul 16, 2018 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 olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-003 Sep 30, 1996 ➤ Sign Up ➤ Sign Up
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000 ➤ Sign Up ➤ Sign Up
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-002 Sep 30, 1996 ➤ Sign Up ➤ Sign Up
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-006 Sep 9, 1997 ➤ Sign Up ➤ Sign Up
Lilly ZYPREXA olanzapine TABLET;ORAL 020592-001 Sep 30, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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