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SYMMETREL

NDA

AMANTADINE HYDROCHLORIDE | N016023 | ENDO PHARMACEUTICALS INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Osmotica Pharmaceutical US LLC et al v. Adamas Pharmaceuticals, Inc. et al 1:2018cv00278 14 patentsANDA 075060amantadine hydrochloride	D. Del.	2018-02-16	Terminated 2021-01-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2016-P-2469 · 6 docket documents Hyman, Phelps & McNamara, P.C. petitioned the FDA under 21 C.F.R. § 314.122 and 314.161 and FDC Act sections 505(j) and 505(w) to determine whether SYMMETREL (amantadine hydrochloride) Syrup, 50 mg/5 mL, approved under NDA 016023 and NDA 017118 and held by Endo Pharmaceuticals, was voluntarily withd	Other	2016-08-10	Granted	Hyman, Phelps & McNamara, P. C.

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

Clinical Trials

64 trials from ClinicalTrials.gov — 1 recruiting, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial NCT04302870	Phase 2/3	Recruiting	University of Edinburgh	1,150	2020-02-27 → 2030-12
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects NCT00979251	Phase 2	Completed	Adamas Pharmaceuticals, Inc.	2	2009-09 → 2011-08
Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)NCT00970944	Phase 2/3	Completed	JFK Medical Center	184	2003-02 → 2010-03
Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease NCT01313845	Phase 4	Completed	Jee-Young Lee	46	2011-02 → 2012-06
Amantadine to Speed Awakening After Cardiac Arrest NCT02486211	Phase 2	Completed	Jon Rittenberger, MD	14	2015-09 → 2018-06-30
Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State NCT00693121	Phase 4	Completed	Methodist Rehabilitation Center	79	2003-04 → 2019-03
Open-Label Safety Study of ADS-5102 in PD Patients With LID NCT02202551	Phase 3	Completed	Adamas Pharmaceuticals, Inc.	223	2014-07 → 2018-02
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine NCT00416962	Phase 1	Completed	Novartis	18	2006-08 → 2006-12
Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2 NCT00158132	Phase 2	Completed	University of Pennsylvania	199	1999-09 → 2006-02
Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects NCT01441986	Phase 2	Completed	Profil Institut für Stoffwechselforschung GmbH	20	2011-09 → 2012-05

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

API Supply Chain5 active DMFs1 inactive

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

MOEHS IBERICA SLAMANTADINE HYDROCHLORIDE

DMF 69241987

OLPHA ASAMANTADINE HYDROCHLORIDE

DMF 235282010

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDAMANTADINE HYDROCHLORIDE USP

DMF 251512011

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAAMANTADINE HYDROCHLORIDE

DMF 294862015

ALEMBIC PHARMACEUTICALS LTDAMANTADINE HYDROCHLORIDE USP

DMF 415172025

NORTHEAST GENERAL PHARMACEUTICAL FACTORYInactiveAMANTADINE HYDROCHLORIDE

DMF 96651992

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 3, 2009	SUPPL -41	View Letter (PDF)
Sep 26, 2008	SUPPL -40	View Letter (PDF)
Mar 7, 2007	SUPPL -39	View Letter (PDF)
Nov 25, 2003	SUPPL -37	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.