Symbyax Drug Patent Profile
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When do Symbyax patents expire, and what generic alternatives are available?
Symbyax is a drug marketed by Lilly and is included in one NDA.
The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for Symbyax
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 5 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Symbyax |
What excipients (inactive ingredients) are in Symbyax? | Symbyax excipients list |
DailyMed Link: | Symbyax at DailyMed |
Recent Clinical Trials for Symbyax
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eli Lilly and Company | Phase 3 |
Eli Lilly and Company | Phase 4 |
M.D. Anderson Cancer Center | Phase 1 |
Pharmacology for Symbyax
Drug Class | Atypical Antipsychotic Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for Symbyax
Paragraph IV (Patent) Challenges for SYMBYAX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SYMBYAX | Capsules | fluoxetine hydrochloride; olanzapine | 6 mg/25 mg 12 mg/25 mg 6 mg/50 mg 12 mg/50 mg | 021520 | 1 | 2005-01-10 |
US Patents and Regulatory Information for Symbyax
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-001 | Apr 9, 2007 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-003 | Dec 24, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-002 | Dec 24, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 Symbyax
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-005 | Dec 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-002 | Dec 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-005 | Dec 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Symbyax
See the table below for patents covering Symbyax around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 911624 | ⤷ Try a Trial | |
Japan | 2527860 | ⤷ Try a Trial | |
Hungary | 212416 | PROCESS FOR PREPARING 2-METHYL-10-(4-METHYL-1-PIPERAZINYL)-4H-THIENO[2,3-B][1,5]-BENZODIAZEPINE AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAID COMPOUND | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Symbyax
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0454436 | 9/1997 | Austria | ⤷ Try a Trial | 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 | ⤷ Try a Trial | |
0454436 | SPC/GB96/058 | United Kingdom | ⤷ Try a Trial | 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 |