ZYPREXA Drug Patent Profile
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Which patents cover Zyprexa, and what generic alternatives are available?
Zyprexa is a drug marketed by Cheplapharm and is included in four NDAs.
The generic ingredient in ZYPREXA is olanzapine pamoate. There are thirty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the olanzapine pamoate profile page.
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Summary for ZYPREXA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 147 |
Clinical Trials: | 130 |
Patent Applications: | 4,698 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZYPREXA |
What excipients (inactive ingredients) are in ZYPREXA? | ZYPREXA excipients list |
DailyMed Link: | ZYPREXA at DailyMed |
![ZYPREXA drug patent expirations Drug patent expirations by year for ZYPREXA](/p/graph/s/t/ZYPREXA-patent-expirations.png)
![Drug Prices for ZYPREXA](/p/graph/drug-price/ZYPREXA.png)
![Drug Sales Revenue Trends for ZYPREXA](/p/graph/drug-sales-revenues/ZYPREXA.png)
Recent Clinical Trials for ZYPREXA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
OHSU Knight Cancer Institute | Phase 2 |
Oregon Health and Science University | Phase 2 |
Yale University | Phase 2 |
Pharmacology for ZYPREXA
Drug Class | Atypical Antipsychotic |
US Patents and Regulatory Information for ZYPREXA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | ZYPREXA | olanzapine | INJECTABLE;INTRAMUSCULAR | 021253-001 | Mar 29, 2004 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-006 | Sep 9, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-003 | Sep 30, 1996 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-002 | Apr 6, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA RELPREVV | olanzapine pamoate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022173-001 | Dec 11, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cheplapharm | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-004 | Apr 6, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-001 | Sep 30, 1996 | AB | RX | Yes | 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 ZYPREXA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-006 | Sep 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-002 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-004 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-002 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-005 | Sep 9, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Cheplapharm | ZYPREXA | olanzapine | TABLET;ORAL | 020592-003 | Sep 30, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ZYPREXA
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 | |
Teva B.V. | Olanzapine Teva | olanzapine | EMEA/H/C/000810 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 | 2007-12-12 | |
Apotex Europe BV | Olanzapine Apotex | olanzapine | EMEA/H/C/001178 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 | 2010-06-10 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZYPREXA
See the table below for patents covering ZYPREXA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I226829 | ⤷ Sign Up | |
Norway | 911624 | ⤷ Sign Up | |
Malaysia | 116503 | PROCESS FOR PREPARING OLANZAPINE | ⤷ Sign Up |
Australia | 643267 | ⤷ Sign Up | |
Australia | 761510 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 9811893 | ⤷ Sign Up | |
Ireland | 911348 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYPREXA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0454436 | C970015 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927 |
0454436 | 9/1997 | Austria | ⤷ Sign Up | PRODUCT NAME: OLANZAPIN ODER EIN SAEUREADDITIONSSALZ HIEVON; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927 |
0454436 | CA 2001 00042 | Denmark | ⤷ Sign Up | |
0454436 | 97C0012 | Belgium | ⤷ Sign Up | PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927 |
0454436 | SPC/GB96/058 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |