SYMBYAX Drug Patent Profile
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Which patents cover Symbyax, and when can generic versions of Symbyax launch?
Symbyax is a drug marketed by Lilly and is included in one NDA.
The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
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Summary for SYMBYAX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 5 |
| 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 |
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 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-003 | Dec 24, 2003 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-002 | Dec 24, 2003 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | 021520-001 | Apr 9, 2007 | 6,960,577 | ⤷ Start Trial |
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-003 | Dec 24, 2003 | 6,960,577 | ⤷ Start Trial |
| Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-005 | Dec 24, 2003 | 5,945,416 | ⤷ Start 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 |
|---|---|---|---|
| Austria | 127804 | ⤷ Start Trial | |
| Australia | 643267 | ⤷ Start Trial | |
| Australia | 7518691 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYMBYAX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0454436 | CA 2001 00042 | Denmark | ⤷ Start Trial | |
| 0454436 | C970015 | Netherlands | ⤷ Start 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 |
| 0454436 | SPC/GB96/058 | United Kingdom | ⤷ Start 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 |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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