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SYMBYAX Drug Profile

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Symbyax is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-six patent family members in twenty-five countries.

The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for Tradename: SYMBYAX

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: SYMBYAX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-001Apr 9, 2007RXNo6,960,577► subscribe ► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-005Dec 24, 2003RXNo► subscribe► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-002Dec 24, 2003RXNo► subscribe► subscribe
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Expired Patents for Tradename: SYMBYAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-001Apr 9, 20075,229,382*PED► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-005Dec 24, 20035,229,382*PED► subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-002Dec 24, 2003522,982► subscribe
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Paragraph IV activity for: SYMBYAX

Drugname Dosage Strength RLD Submissiondate
olanzapine and fluoxetine hydrochlorideCapsules3 mg/25 mgSymbyax5/8/2008
olanzapine and fluoxetine hydrochlorideCapsules6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mgSymbyax1/10/2005

Premature patent expiration for: SYMBYAX

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
5,945,416
SYMBYAX
August 31, 2011

International Patent Family for Tradename: SYMBYAX

Country Document Number Estimated Expiration
Slovakia17512000► subscribe
Indonesia26861► subscribe
Norway984431► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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. thinkBiotech performs no independent verifification 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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