SYMBYAX Drug Patent Profile
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Which patents cover Symbyax, 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 | |||
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-004 | Dec 24, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-005 | 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 | 021520-002 | 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 | 021520-002 | Dec 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-001 | Apr 9, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-003 | Dec 24, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-003 | 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 |
|---|---|---|---|
| Yugoslavia | 42198 | ⤷ Try a Trial | |
| Czech Republic | 279937 | Farmaceutické směsi a způsob výroby jejich učinné látky (2-METHYL-10-(4-METHYL-1-PIPERAZINYL(-4H-THIENO/2,3-b/ /1,5/BENZODIAZEPINE PROCESS OF ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF) | ⤷ Try a Trial |
| Slovenia | 9110739 | PROCESS FOR OBTAINING OF 2-METHYL-10-(4-METHYL-1-PIPERAZINYL)-4H-THIENO 2,3-b 1,5 BENZODIAZEPINE | ⤷ Try a Trial |
| Japan | 2000507945 | ⤷ Try a Trial | |
| Norway | 318035 | ⤷ Try a Trial | |
| Taiwan | I226829 | ⤷ 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 |
| 0454436 | 97C0012 | Belgium | ⤷ Try a Trial | PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927 |
| 0454436 | C970015 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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