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Generated: December 15, 2018

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Dalfampridine - Generic Drug Details

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What are the generic drug sources for dalfampridine and what is the scope of dalfampridine patent protection?

Dalfampridine is the generic ingredient in two branded drugs marketed by Acorda, Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma Ltd, and West-ward Pharms Int, and is included in six NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dalfampridine has fifty-three patent family members in twenty-three countries.

There are ten drug master file entries for dalfampridine. Five suppliers are listed for this compound. There are five tentative approvals for this compound.

Pharmacology for dalfampridine
Synonyms for dalfampridine
.gamma.-Aminopyridine
(T)4-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, 98% 50g
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
AB00052209_12
AB1004971
AC1L1C3R
AC1Q52BM
ACT05167
AI3-52547
AK-77153
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
BB_SC-6974
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
D08YIN
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
HE009136
HE241194
HE346274
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
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
Tentative approvals for DALFAMPRIDINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial0.0TABLET;ORAL

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
West-ward Pharms Int DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206646-001 Oct 24, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Fl Inc DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206836-001 Jan 23, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd DALFAMPRIDINE dalfampridine TABLET, EXTENDED RELEASE;ORAL 206811-001 Jan 23, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for dalfampridine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Acorda AMPYRA dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250-001 Jan 22, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for dalfampridine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013015 Lithuania ➤ Try a Free Trial PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720
2013 00045 Denmark ➤ Try a Free Trial
0120002 00051 Estonia ➤ Try a Free Trial PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
00515 Netherlands ➤ Try a Free Trial PRODUCT NAME: FAMPRIDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Department of Justice
Harvard Business School
Mallinckrodt
Argus Health
UBS
Covington
Deloitte
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.