Viewing data from:

SYMBYAX

NDA

FLUOXETINE HYDROCHLORIDE; OLANZAPINE | N021520 | ELI LILLY AND CO

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Symbyax (2023)

Total Spending

$65K

Total Claims

134

Beneficiaries

Avg Cost/Unit

$11.79

Spending Trend

$287K(2019)→$197K(2020)→$112K(2021)→$88K(2022)→$65K(2023)

YoY Change:-2.4%

5yr CAGR:-5.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

39 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -56	View Letter (PDF)
Aug 22, 2023	SUPPL -55	View Letter (PDF)
Sep 23, 2021	SUPPL -54	View Letter (PDF)
Mar 5, 2021	SUPPL -52	View Letter (PDF)
Oct 27, 2020	SUPPL -51	View Letter (PDF)
Apr 22, 2020	SUPPL -53	View Letter (PDF)
Mar 29, 2018	SUPPL -50	View Letter (PDF)
Mar 29, 2017	SUPPL -42	View Letter (PDF)
Mar 2, 2017	SUPPL -49	View Letter (PDF)
Mar 2, 2017	SUPPL -48	View Letter (PDF)
Jan 13, 2017	SUPPL -47	View Letter (PDF)
Oct 14, 2016	SUPPL -46	View Letter (PDF)
Dec 23, 2014	SUPPL -34	View Letter (PDF)
Oct 15, 2014	SUPPL -41	View Letter (PDF)
Jul 24, 2014	SUPPL -45	View Letter (PDF)
Aug 8, 2013	SUPPL -40	View Letter (PDF)
Jul 30, 2013	SUPPL -39	View Letter (PDF)
Jul 30, 2013	SUPPL -37	View Letter (PDF)
Jan 7, 2013	SUPPL -36	View Letter (PDF)
Jan 7, 2013	SUPPL -35	View Letter (PDF)
Aug 9, 2012	SUPPL -38	View Letter (PDF)
Oct 5, 2011	SUPPL -33	View Letter (PDF)
Jun 27, 2011	SUPPL -31	View Letter (PDF)
Jun 27, 2011	SUPPL -32	View Letter (PDF)
Apr 25, 2011	SUPPL -28	View Letter (PDF)
Apr 25, 2011	SUPPL -25	View Letter (PDF)
Dec 7, 2010	SUPPL -29	View Letter (PDF)
Dec 7, 2010	SUPPL -27	View Letter (PDF)
Feb 1, 2010	SUPPL -23	View Letter (PDF)
Aug 19, 2008	SUPPL -20	View Letter (PDF)
Mar 24, 2008	SUPPL -17	View Letter (PDF)
Mar 19, 2008	SUPPL -16	View Letter (PDF)
Aug 7, 2007	SUPPL -13	View Letter (PDF)
Aug 7, 2007	SUPPL -14	View Letter (PDF)
Apr 20, 2007	SUPPL -8	View Letter (PDF)
Apr 20, 2007	SUPPL -10	View Letter (PDF)
Dec 28, 2006	SUPPL -9	View Letter (PDF)
Feb 23, 2005	SUPPL -5	View Letter (PDF)
Jan 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 25MG BASE;EQ 3MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 9, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE;EQ 6MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 24, 2003

#003 — EQ 50MG BASE;EQ 6MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 24, 2003

#004 — EQ 25MG BASE;EQ 12MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 24, 2003

#005 — EQ 50MG BASE;EQ 12MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 24, 2003