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Generated: December 16, 2018

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Ranolazine - Generic Drug Details

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

Ranolazine is the generic ingredient in two branded drugs marketed by Gilead and Lupin Ltd, and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ranolazine has ninety-eight patent family members in twenty-nine countries.

There are twenty-one drug master file entries for ranolazine. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Medical Subject Heading (MeSH) Categories for ranolazine
Synonyms for ranolazine
( )-Ranolazine
(-)-Ranolazine
(+-)-N-(2,6-Dimethylphenyl)-4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)-1-piperazineacetamide
(+-)-Ranolazine
(+/-)-1-(3-(2-Methoxyphenoxy)-2-hydroxypropyl)-4-(n-(2,6-dimethylphenyl)carbamoylmethyl)piperazine
(+/-)-4-(2-Hydroxy-3-(o-methoxyphenoxy)propyl)-1-piperazineaceto-2',6'-xylidide
1-[3-(2-methoxyphenoxy)-2-hydroxypropyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine
1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)-
1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)-, (+-)-
1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-
110445-25-5
142387-99-3
4CA-1078
635R555
95635-55-5
A11162
AB0007809
AB00698532_16
AB00698532_17
AB00698532_18
AB00698532-11
AB00698532-13
AB00698532-14
AB00698532-15
AB2000299
AC-1673
AC-3497
AC1L1M17
AC1Q5LYD
ACT06286
AK-72950
AKOS015889500
AN-5494
BC205445
BCP0726000090
BCP9000558
BDBM50173335
BR-72950
BRD-A97674275-001-01-9
BSPBio_002276
C24H33N3O4
CAS-95635-55-5
CCG-205139
CHEBI:87690
CHEMBL1404
CR0012
CS-2292
CTK3I7295
CVT 303
CVT 303;RS 43285-003
CVT-303
D03HYQ
D05700
D06TES
DB00243
DR002639
DSSTox_CID_25196
DSSTox_GSID_45196
DSSTox_RID_80743
DTXSID3045196
FT-0601594
GTPL7291
H959
HE292530
HE419447
HMS1922F16
HMS2090L09
HMS2093D21
HMS2098K06
HMS2230C19
HMS3369I08
HMS3655M12
HSDB 7924
HY-B0280
I01-2008
I06-0160
KB-298373
KEG-1295
KS-00000JS7
KS-1244
Latixa
Lopac0_001062
LS-187267
MCULE-8182023610
MFCD00864690
MLS002154149
MolPort-003-666-653
N-(2,6-Dimethyl-phenyl)-2-{4-[2-hydroxy-3-(2-methoxy-phenoxy)-propyl]-piperazin-1-yl}-acetamide
N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)piperazin-1-yl)acetamide
N-(2,6-dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide
N-(2,6-dimethylphenyl)-2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetamide
N-(2,6-dimethylphenyl)-2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}ethanimidic acid
N-(2,6-dimethylphenyl)-4-(2-hydroxy-3-(2-methoxyphenoxy)propyl)-1-piperazineacetamide
N-(2,6-DIMETHYLPHENYL)-4-[2-[2-HYDROXY-3-(2-METHOXYPHENOXY)PROPYL]PIPERAZIN-1-YL]ACETAMIDE
N-(2,6-DIMETHYLPHENYL)-4-[2-HYDROXY-3-(2-METHOXYPHENOXY)PROPYL]-1-PIPERAZINEACETAMIDE
NCGC00015897-02
NCGC00015897-03
NCGC00015897-04
NCGC00015897-05
NCGC00015897-06
NCGC00015897-08
NCGC00095177-01
NCGC00095177-02
NCGC00095177-03
NSC-759100
NSC759100
PB21724
Pharmakon1600-01505366
RAN D
Ran4
Ranexa
Ranexa (TN)
Ranexa, Ranolazine
Ranolazine 1g
Ranolazine (Ranexa)
Ranolazine (USAN/INN)
Ranolazine [USAN:INN:BAN]
Ranolazine 2HCl
Ranolazine/Dronedarone Fixed-Dose Combination
renexa
RS-43285
RS-43285-003
S-1794
s1799
SBI-0051032.P002
SC-25810
SCHEMBL124665
SMR000857382
SPECTRUM1505366
ST24025536
Tox21_110258
Tox21_110258_1
TR-031802
XKLMZUWKNUAPSZ-UHFFFAOYSA-N
Z68563450
Tentative approvals for RANOLAZINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1000MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up500MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GMTABLET, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for ranolazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 ranolazine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 ➤ Sign Up ➤ Sign Up
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ranolazine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558/01 Switzerland ➤ Sign Up PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: SWISSMEDIC 60553 13.04.2010
08/034 Ireland ➤ Sign Up PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1 Finland ➤ Sign Up
C/GB08/058 United Kingdom ➤ Sign Up PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 - 006 20080714
0371 Netherlands ➤ Sign Up PRODUCT NAME: RANOLAZINE OF EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
McKesson
US Department of Justice
Cantor Fitzgerald
Chubb
Julphar
Accenture
Covington
Argus Health

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.