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

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Last Updated: December 13, 2019

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DALFAMPRIDINE Drug Profile

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Which patents cover Dalfampridine, and when can generic versions of Dalfampridine launch?

Dalfampridine is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, Micro Labs, Sun Pharm, and West-ward Pharms Int. and is included in seven NDAs.

The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.

US ANDA Litigation and Generic Entry Outlook for Dalfampridine

A generic version of DALFAMPRIDINE was launched as dalfampridine by ACTAVIS LABS FL INC on December 13th, 2019.

Drug patent expirations by year for DALFAMPRIDINE
Drug Prices for DALFAMPRIDINE

See drug prices for DALFAMPRIDINE

Recent Clinical Trials for DALFAMPRIDINE

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

SponsorPhase
Milton S. Hershey Medical CenterPhase 1/Phase 2
Hospital for Special Surgery, New YorkPhase 1
Weill Medical College of Cornell UniversityPhase 1

See all DALFAMPRIDINE clinical trials

Recent Litigation for DALFAMPRIDINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc.2015-03-17
Acorda Therapeutics Inc. v. Actavis Laboratories FL, Inc.2015-01-23
Acorda Therapeutics Inc. v. Apotex Corp.2014-07-18

See all DALFAMPRIDINE litigation

PTAB Litigation
PetitionerDate
Coalition for Affordable Drugs (ADROCA) LLC2015-09-03
Coalition For Affordable Drugs (ADROCA) LLC2015-09-02
Coalition for Affordable Drugs (ADROCA) LLC2015-02-27

See all DALFAMPRIDINE litigation

Pharmacology for DALFAMPRIDINE
Synonyms for DALFAMPRIDINE
.gamma.-Aminopyridine
[J.Pharmacol.Exp.Ther. 275:864 (1995)]
29212-32-6
3rxf
4 Aminopyridine
4 AP
4- Aminopyridine
4-amino pyridine
4-amino-pyridine
4-AMINOPYRDINE
4-aminopyridine
4-Aminopyridine 10
4-Aminopyridine, >=99%
4-Aminopyridine, 98%
4-Aminopyridine, PESTANAL(R), analytical standard
4-AP
4-imino-1,4-dihydropyridine
4-Pyridinamine
4-Pyridinamine, 4-Pyridylamine
4-Pyridinamine; Fampridine
4-pyridyl amine
4-Pyridylamine
4(1H)-Pyridinimine
4AP
5-22-09-00106 (Beilstein Handbook Reference)
504-24-5
68146-EP2269990A1
68146-EP2284157A1
68146-EP2289894A2
68146-EP2298731A1
68146-EP2308874A1
68146-EP2380872A1
79676-EP2305695A2
79676-EP2305696A2
79676-EP2305697A2
79676-EP2305698A2
A 0152
A0414
A106
AB00052209_12
AB1004971
AC1L1C3R
AC1Q52BM
ACT05167
AI3-52547
AKOS000119896
AM20061261
Amaya
Amino-4 pyridine
Amino-4-Pyridine
AMPD00207
Ampydin
Ampyra
Ampyra (TN)
AN-45400
ANW-75388
ARONIS25052
Avitrol
Avitrol 200
AZ0001-0464
B3530
BBL009925
BC227053
BDBM10458
BH3B64OKL9
BIIB 041
BIIB-041
BIIB041
Bio1_000353
Bio1_000842
Bio1_001331
Bio2_000282
Bio2_000762
BP-21343
BRN 0105782
BS-3729
BSPBio_001562
C13728
C5H6N2
CAS-504-24-5
Caswell No. 038
CCG-39031
CHEBI:34385
CHEMBL284348
CL-COB-III-274-1
Compound 1861
CS-2822
CTK0J1462
D04127
Dalfampridine (USAN)
Dalfampridine [USAN:INN]
Dalfampridine-ER
Dalfampridine, United States Pharmacopeia (USP) Reference Standard
DB-028705
DB06637
DivK1c_000572
DSSTox_CID_3870
DSSTox_GSID_23870
DSSTox_RID_77212
DTXSID0023870
EINECS 207-987-9
EL-970
EPA Pesticide Chemical Code 069201
EU-0100032
F2190-0487
fampridina
Fampridine
Fampridine (JAN/INN)
Fampridine [INN]
Fampridine [USAN:INN]
Fampridine-PR
Fampridine-SR
fampridinum
FAMPYRA
Fampyra (TN)
Frampridine
FT-0083754
FT-0617606
gamma-Aminopyridine
GTPL2416
HC150041
HMS1361O04
HMS1791O04
HMS1921H15
HMS1989O04
HMS2092F05
HMS2234N24
HMS3260G05
HMS3267E21
HMS3370J03
HMS3402O04
HMS501M14
HSDB 6037
HTS004685
HY-B0604
IDI1_000572
IDI1_034032
InChI=1/C5H6N2/c6-5-1-3-7-4-2-5/h1-4H,(H2,6,7
KB-36586
KBio1_000572
KBio2_000282
KBio2_000635
KBio2_002850
KBio2_003203
KBio2_005418
KBio2_005771
KBio3_000563
KBio3_000564
KBio3_001888
KBioGR_000282
KBioGR_001505
KBioSS_000282
KBioSS_000635
KS-0000057B
KS-000046YS
KUC111877N
Lopac-A-0152
Lopac0_000032
LP00032
LS-130202
LS20499
M-6065
MCULE-6604546217
MFCD00006439
Mi-W-3
MLS000069400
MolPort-000-146-022
N07XX07
NCGC00015009-01
NCGC00015009-02
NCGC00015009-03
NCGC00015009-04
NCGC00015009-05
NCGC00015009-06
NCGC00015009-07
NCGC00015009-08
NCGC00015009-09
NCGC00015009-10
NCGC00015009-11
NCGC00015009-12
NCGC00015009-13
NCGC00015009-14
NCGC00015009-16
NCGC00024890-01
NCGC00024890-02
NCGC00024890-03
NCGC00024890-04
NCGC00024890-05
NCGC00024890-06
NCGC00024890-07
NCGC00024890-08
NCGC00024890-09
NCGC00024890-10
NCGC00258347-01
NCGC00260717-01
Neurelan
Neurelan (TN)
NINDS_000572
NSC 15041
NSC-15041
NSC-757845
NSC15041
NSC757845
NUKYPUAOHBNCPY-UHFFFAOYSA-N
Opera_ID_1768
p-Aminopyridine
p-Aminopyridine [UN2671] [Poison]
p-Aminopyridine [UN2671] [Poison]
Pharmakon1600-01501130
Philips 1861
Phillips 1861
Pimadin (free base)
Prc 1237
PubChem1281
Pymadin
Pymadine
pyridin-4-amine
pyridin-4-yl-amine
pyridin-4-ylamine
pyridine-4-amine
pyridine-4-ylamine
Pyridine, 4-amino-
PYRIDINE,4-AMINO
Q-200436
QC-4324
RB8003
RCRA waste no. P008
RP18049
RW2023
SBB004393
SBI-0050021.P003
SC-04870
SDCCGMLS-0066228.P001
SMR000058211
SPBio_001486
Spectrum_000155
SPECTRUM1501130
Spectrum2_001413
Spectrum3_000914
Spectrum4_001013
Spectrum5_001501
SR-01000075299
SR-01000075299-1
SR-01000075299-3
SR-01000075299-5
ST45053817
STK298717
TC-063856
TC-164133
TL8003344
Tocris-0940
Tox21_110065
Tox21_110065_1
Tox21_200793
Tox21_500032
UNII-BH3B64OKL9
UPCMLD-DP125
UPCMLD-DP125:001
VMI 10-3
VMI 103
VMI-10-3
VMI-103
VP10051
WLN: T6NJ DZ
Z955123498
ZINC599985
Paragraph IV (Patent) Challenges for DALFAMPRIDINE
Tradename Dosage Ingredient NDA Submissiondate
AMPYRA TABLET, EXTENDED RELEASE;ORAL dalfampridine 022250 2014-01-22

US Patents and Regulatory Information for DALFAMPRIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206863-001 Jul 11, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206646-001 Oct 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206811-001 Jan 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206836-001 Jan 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206765-001 Jul 30, 2018 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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