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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 patent protection?

Olanzapine is the generic ingredient in four branded drugs marketed by Am Regent, 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, 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, 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. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for olanzapine

US Patents:	0
Tradenames:	4
Applicants:	27
NDAs:	39
Drug Master File Entries:	33
Suppliers / Packagers:	39
Bulk Api Vendors:	113
Clinical Trials:	420
Patent Applications:	4,896
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for olanzapine
Drug Sales Revenues:	Drug sales revenues for olanzapine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olanzapine
DailyMed Link:	olanzapine at DailyMed

See drug prices for olanzapine

See drug sales revenues for olanzapine

Recent Clinical Trials for olanzapine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Augusta University	Phase 4
CR-CSSS Champlain-Charles-Le Moyne	Phase 3
Corcept Therapeutics	Phase 1

See all olanzapine clinical trials

Recent Litigation for olanzapine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ALCON MANUFACTURING, LTD v. APOTEX INC.	2006-11-15
Bayer AG v. Dr. Reddy's Lab.Ltd.	2004-03-24
ELI LILLY AND COMPANY v. ZENITH GOLDLINE PHARMACEUTICALS, INC.

See all olanzapine litigation

Generic filers with tentative approvals for OLANZAPINE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL

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

Pharmacology for olanzapine

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for OLANZAPINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ZYPREXA ZYDIS	TABLET, ORALLY DISINTEGRATING;ORAL	olanzapine	021086
ZYPREXA	TABLET;ORAL	olanzapine	020592

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
Dr Reddys Labs Ltd	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	076534-001	Oct 24, 2011	AB	RX	No	No
Jiangsu Hansoh Pharm	OLANZAPINE	olanzapine	TABLET;ORAL	209399-003	Sep 24, 2018	AB	RX	No	No
Lilly	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	AB	RX	Yes	No
Sun Pharm Inds	OLANZAPINE	olanzapine	TABLET;ORAL	091038-006	Apr 23, 2012	AB	RX	No	No

Expired US Patents for olanzapine

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