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, Aspiro, Eugia Pharma, Sandoz Inc, Cheplapharm, 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, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, and Alkermes Inc, and is included in forty-seven NDAs. There are thirteen 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. Forty-seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for olanzapine
US Patents: | 13 |
Tradenames: | 5 |
Applicants: | 33 |
NDAs: | 47 |
Drug Master File Entries: | 33 |
Finished Product Suppliers / Packagers: | 47 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 503 |
Patent Applications: | 7,746 |
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 |
---|---|
Minerva Neurosciences | Phase 1 |
Simon Williamson Clinic | Phase 2 |
Helsinn Healthcare SA | Phase 2 |
Generic filers with tentative approvals for OLANZAPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eugia Pharma | OLANZAPINE | olanzapine | INJECTABLE;INTRAMUSCULAR | 210968-001 | Oct 22, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA RELPREVV | olanzapine pamoate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022173-002 | Dec 11, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alkermes Inc | LYBALVI | olanzapine; samidorphan l-malate | TABLET;ORAL | 213378-003 | May 28, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Macleods Pharms Ltd | OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 203044-004 | Feb 20, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Qilu | OLANZAPINE | olanzapine | TABLET;ORAL | 204319-003 | Jan 27, 2016 | 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 |
Expired US Patents for olanzapine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-001 | Apr 6, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-001 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-006 | Sep 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-001 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | 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 |
EU/EMA Drug Approvals for olanzapine
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Eli Lilly Nederland B.V. | Zyprexa Velotab | olanzapine | EMEA/H/C/000287 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | no | no | no | 2000-02-03 | |
Eli Lilly Nederland B.V. | Zypadhera | olanzapine | EMEA/H/C/000890 Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. |
Authorised | no | no | no | 2008-11-19 | |
Eli Lilly Nederland B.V. | Zyprexa | olanzapine | EMEA/H/C/000115 Coated tabletsAdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate. |
Authorised | no | no | no | 1996-09-27 | |
Krka | Zalasta | olanzapine | EMEA/H/C/000792 Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | yes | no | no | 2007-09-27 | |
Mylan Pharmaceuticals Limited | Olanzapine Mylan | olanzapine | EMEA/H/C/000961 AdultsOlanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode.In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. |
Authorised | yes | no | no | 2008-10-06 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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