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Olanzapine - Generic Drug Details

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What are the generic sources for olanzapine and what is the scope of patent protection?

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

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

Summary for olanzapine

US Patents:	0
Tradenames:	4
Applicants:	29
NDAs:	43
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	439
Patent Applications:	7,130
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for olanzapine
Drug Sales Revenues:	Drug sales revenues for olanzapine
What excipients (inactive ingredients) are in olanzapine?	olanzapine excipients list
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
Tan Tock Seng Hospital	Phase 3
HCA Hospice Care	Phase 2
Amani Hassan Abdel-Wahab	Phase 1/Phase 2

See all olanzapine clinical trials

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	TABLET;ORAL	olanzapine	020592
ZYPREXA ZYDIS	TABLET, ORALLY DISINTEGRATING;ORAL	olanzapine	021086

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
Apotex Inc	OLANZAPINE	olanzapine	TABLET;ORAL	090798-005	Apr 23, 2012	AB	RX	No	No
Hisun Pharm Hangzhou	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	206892-002	Dec 31, 2020	AB	RX	No	No
Invagen Pharms	OLANZAPINE	olanzapine	TABLET;ORAL	203333-001	Mar 15, 2016	AB	RX	No	No
Torrent Pharms Llc	OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	091415-001	Oct 25, 2011	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	021086-001	Apr 6, 2000
Lilly	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996
Lilly	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000