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Last Updated: March 28, 2024

Fluoxetine hydrochloride; olanzapine - Generic Drug Details


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What are the generic sources for fluoxetine hydrochloride; olanzapine and what is the scope of freedom to operate?

Fluoxetine hydrochloride; olanzapine is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Par Pharm, Teva Pharms, and Lilly, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for fluoxetine hydrochloride; olanzapine
Recent Clinical Trials for fluoxetine hydrochloride; olanzapine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital of Chongqing Medical UniversityPhase 1/Phase 2
Second Xiangya Hospital of Central South UniversityPhase 1/Phase 2
First Affiliated Hospital of Zhejiang UniversityPhase 4

See all fluoxetine hydrochloride; olanzapine clinical trials

Pharmacology for fluoxetine hydrochloride; olanzapine
Paragraph IV (Patent) Challenges for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
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 fluoxetine hydrochloride; olanzapine

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 021520-005 Dec 24, 2003 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077742-001 Nov 2, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-003 Nov 16, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-001 Nov 16, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-004 Nov 16, 2012 AB RX No 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 fluoxetine hydrochloride; olanzapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021520-001 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 021520-005 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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