Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Last Updated: December 12, 2019

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AMANTADINE HYDROCHLORIDE Drug Profile

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When do Amantadine Hydrochloride patents expire, and what generic alternatives are available?

Amantadine Hydrochloride is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Lannett Co Inc, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, and Jubilant Generics. and is included in twenty-six NDAs.

The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Amantadine Hydrochloride

A generic version of AMANTADINE HYDROCHLORIDE was launched as amantadine hydrochloride by UPSHER SMITH LABS on December 12th, 2019.

Drug patent expirations by year for AMANTADINE HYDROCHLORIDE
Recent Clinical Trials for AMANTADINE HYDROCHLORIDE

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

SponsorPhase
University Hospital, Strasbourg, FrancePhase 2
TC Erciyes UniversityPhase 4
University of MalagaPhase 3

See all AMANTADINE HYDROCHLORIDE clinical trials

Recent Litigation for AMANTADINE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Osmotica Pharmaceutical US LLC v. Adamas Pharmaceuticals, Inc.2018-02-16

See all AMANTADINE HYDROCHLORIDE litigation

Pharmacology for AMANTADINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for AMANTADINE HYDROCHLORIDE
Synonyms for AMANTADINE HYDROCHLORIDE
(3R,5S,7s)-Adamantan-1-amine hydrochloride
(3s,5s,7s)-adamantan-1-amine hydrochloride
1-Adamantanamin Hydrochlorid
1-Adamantanamine HCl
1-Adamantanamine hydrochloride
1-Adamantanamine hydrochloride, 99+%
1-Adamantanamine hydrochloride; 1-Adamantylamine hydrochloride; 1-Aminoadamantane hydrochloride
1-Adamantanamine, hydrochloride
1-Adamantanaminehydrochloride
1-Adamantylamine hydrochloride
1-aminoada- mantane hydrochloride
1-Aminoadamantane hydrochloride
1-Aminoadamantene hydrochloride
13878-11-0
665-66-7
768-94-5 (Parent)
A 1260
A0588
A3A501
AB0014024
AB1008533
AC-8689
AC1L20JO
ACMC-209nvq
Adamantamine hydrochloride
adamantan-1-amine hydrochloride
adamantan-1-amine;hydrochloride
adamantan-1-aminium chloride
Adamantanamine HCl
Adamantanamine hydrochloride
adamantanylamine, chloride
Adamantine hydrochloride
adamantyl amine hydrochloride
Adamantylamine hydrochloride
Adamin
Adamine
ADS-5101
ADS-5102
AI3-52211
AK-40714
AKOS015900347
AKOS015951188
Amantadine (hydrochloride)
Amantadine HCl
Amantadine hydrochloride (JP17/USP)
Amantadine hydrochloride (Symmetrel)
Amantadine hydrochloride [USAN:JAN]
Amantadine hydrochloride [USAN:USP:JAN]
Amantadine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Amantadine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Amantadine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Amantan
amantidine hydrochloride
Amazolon
Aminoadamantane hydrochloride
AN-7740
ANW-35220
AOB5792
BC204764
BCP11857
C07939
CA-1982
CCG-38899
Cerebramed
CHEBI:2619
CHEMBL1255870
CHEMBL1569
CPD001370746
CS-2502
CTK2F3028
D00777
EBD2156754
EC 211-560-2
EINECS 211-560-2
EU-0100004
EXP 105-1
Exp-105-1
F3111-1111
FT-0622248
GP 38026
HMS1920A19
Hofcomant
HY-B0402A
I14-0454
Influenol
J-650095
J-650235
K091
KB-11068
KS-000009I7
KSC353A2R
LP00004
LS-14931
Lysovir
M6Q1EO9TD0
Mantadan
Mantadine
Mantadix
MCULE-2948891352
MFCD00074723
MFCD00074723 (98%)
Midantan
Midantane
MLS000028731
MLS002153257
MLS003899199
MolPort-000-692-440
MolPort-003-925-531
MolPort-038-942-500
Mydantane
N04BB01
NC00489
NCGC00093531-01
NCGC00093531-02
NCGC00093531-03
NCGC00093531-04
NCGC00260689-01
NSC 83653
NSC-755860
NSC-83653
NSC755860
NSC83653
Nurelin
Opera_ID_671
Pharmakon1600-01500110
PubChem6390
Q-200621
RTR-022507
s2451
SAM002554881
SBB003680
SC-06172
SCHEMBL40713
SMR000059204
SMR001370746
SPECTRUM1500110
SR-01000075353
SR-01000075353-1
ST24032190
ST50508424
STR01017
SW219892-1
SY012930
Symmetrel
Symmetrel (TN)
TL8004713
Tox21_500004
TR-022507
TRA0093399
Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, hydrochloride
Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, hydrochloride (9CI)
Tricyclo(3.3.1.13,7)decan-1-amine, hydrochloride
Tricyclo[3.3.1.1 3,7]decan-1-amine hydrochloride
Tricyclo[3.3.1.13, hydrochloride
Tricyclo[3.3.1.13,7]decan-1-amine hydrochloride
Tricyclo[3.3.1.13,7]decan-1-amine, hydrochloride
Tricyclodecane
Trivaline
UNII-M6Q1EO9TD0
V2452
Virasol
Viregyt
Virofral
Virosol
WLN: L66 B6 A B- C 1B ITJ BZ &GH
WOLHOYHSEKDWQH-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for AMANTADINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GOCOVRI CAPSULE, EXTENDED RELEASE;ORAL amantadine hydrochloride 208944 2018-01-16

US Patents and Regulatory Information for AMANTADINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 077659-001 Feb 23, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Pharm Assoc AMANTADINE HYDROCHLORIDE amantadine hydrochloride SYRUP;ORAL 074509-001 Jul 17, 1995 AA RX No Yes   Start Trial   Start Trial   Start Trial
Strides Pharma AMANTADINE HYDROCHLORIDE amantadine hydrochloride TABLET;ORAL 209035-001 Jun 9, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 071293-001 Feb 18, 1987 AB RX No Yes   Start Trial   Start Trial   Start Trial
Heritage Pharma AMANTADINE HYDROCHLORIDE amantadine hydrochloride CAPSULE;ORAL 209171-001 Jun 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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McKesson
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Dow
Medtronic

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