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 five branded drugs marketed by Am Regent, Eugia Pharma, Sandoz Inc, Lilly, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Alkem Labs Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, Eli Lilly Co, and Alkermes Inc, and is included in forty-four NDAs. There are nine patents protecting this compound. 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.
Summary for olanzapine
US Patents: | 9 |
Tradenames: | 5 |
Applicants: | 31 |
NDAs: | 44 |
Drug Master File Entries: | 33 |
Finished Product Suppliers / Packagers: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 131 |
Clinical Trials: | 483 |
Patent Applications: | 6,877 |
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 |
Recent Clinical Trials for olanzapine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Phase 3 |
University of Pennsylvania | Phase 2 |
Shi Yanxia | Phase 3 |
Pharmacology for olanzapine
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for olanzapine
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms | OLANZAPINE | olanzapine | TABLET;ORAL | 090459-006 | Jul 16, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Dr Reddys Labs Ltd | OLANZAPINE | olanzapine | TABLET;ORAL | 076255-002 | Apr 23, 2012 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-003 | May 28, 2021 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | See Plans and Pricing | See Plans and Pricing |
Lilly | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-004 | Apr 6, 2000 | See Plans and Pricing | See Plans and Pricing |
Lilly | ZYPREXA | olanzapine | TABLET;ORAL | 020592-002 | Sep 30, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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