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PATANASE

NDA

OLOPATADINE HYDROCHLORIDE | N021861 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Sterne, Kessler, Goldstein & Fox, P.L.L.C. FDA-2005-P-0190 · 6 docket documents Sterne, Kessler, Goldstein & Fox, P.L.L.C., a law firm, filed this citizen petition on October 5, 2005, requesting that the FDA Commissioner refrain from accepting the proposed trade name PATANASE for Alcon's pending new drug application (NDA) for olopatadine hydrochloride nasal spray, or alternativ	Other	2009-02-19	Denied	Sterne, Kessler, Goldstein & Fox, P.L.L.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

49 trials from ClinicalTrials.gov, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Olopatadine Eye Drops and Allergy Skin Testing NCT00775658	N/A	Completed	Vanderbilt University Medical Center	24	2008-01 → 2008-06
Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis NCT00836485	Phase 2	Completed	Senju USA, Inc.	122	2009-02 → 2009-03
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)NCT01435460	Phase 3	Completed	Bausch & Lomb Incorporated	300	2010-08 → 2011-05
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid NCT00845195	Phase 4	Completed	Alcon Research	150	2009-03
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects NCT00987272	Phase 3	Completed	Alcon Research	267	2009-10 → 2009-11
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)NCT02478398	Phase 3	Completed	Merck Sharp & Dohme LLC	1,025	2015-07-20 → 2018-11-19
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis NCT01363700	Phase 3	Completed	Santen Pharmaceutical Co., Ltd.	87	—
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis NCT01743027	Phase 3	Completed	Alcon Research	902	2013-01 → 2013-07
Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)NCT00550550	Phase 3	Completed	ALK-Abelló A/S	345	2007-11 → 2009-09
Safety Study of Olopatadine Nasal Spray NCT00578331	Phase 3	Completed	Alcon Research	890	2006-12 → 2008-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs4 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

CURIA SPAIN SAUOLOPATADINE HYDROCHLORIDE (PROCESS I)

DMF 195262006

INDOCO REMEDIES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 241062010

USV PRIVATE LTDOLOPATADINE HYDROCHLORIDE USP

DMF 245422011

MSN LABORATORIES PRIVATE LTDOLOPATADINE HYDROCHLORIDE USP [ROUTE CODE - "OH"]

DMF 246242011

CURIA SPAIN SAUOLOPATADINE HYDROCHLORIDE, USP (PROCESS II)

DMF 250442011

FIS FABBRICA ITALIANA SINTETICI SPAOLOPATADINE HYDROCHLORIDE

DMF 262972012

KYOWA PHARMA CHEMICAL CO LTDOLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 283892014

FDC LTDOLOPATADINE HYDROCHLORIDE USP

DMF 294642015

SUN PHARMACEUTICAL INDUSTRIES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 298652015

ALIVUS LIFE SCIENCES LTDOLOPATADINE HYDROCHLORIDE USP

DMF 317612017

KYOWA KIRIN CO LTDInactiveOLOPATADINE HYDROCHLORIDE (KW 4679)

DMF 118011996

URQUIMA SAInactiveOLOPATADINE HYDROCHLORIDE

DMF 194172006

FIS FABBRICA ITALIANA SINTETICI SPAInactiveOLOPATADINE HYDROCHLORIDE

DMF 232402009

APOTEX PHARMACHEM INDIA PVT LTDInactiveOLOPATADINE HYDROCHLORIDE USP

DMF 271712013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 5, 2021	SUPPL -15	View Letter (PDF)
Oct 28, 2015	SUPPL -11	View Letter (PDF)
Feb 27, 2012	SUPPL -9	View Letter (PDF)
Apr 5, 2010	SUPPL -8	View Letter (PDF)
Jan 26, 2010	SUPPL -2	View Letter (PDF)
Apr 22, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Apr 15, 2008

No patent or exclusivity listings for this strength.