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Last Updated: November 21, 2019

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RANEXA Drug Profile

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Which patents cover Ranexa, and what generic alternatives are available?

Ranexa is a drug marketed by Gilead and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred patent family members in twenty-nine countries.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

Drug patent expirations by year for RANEXA
Drug Prices for RANEXA

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Drug Sales Revenue Trends for RANEXA

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Recent Clinical Trials for RANEXA

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SponsorPhase
IRCCS San RaffaelePhase 2
Menarini International Operations Luxembourg SAPhase 2
Ohio State UniversityPhase 2

See all RANEXA clinical trials

Recent Litigation for RANEXA

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District Court Litigation
Case NameDate
Shire LLC, Supernus Pharmaceuticals, Incl v. IMPAX Laboratories, Inc.2010-12-02
ROCHE PALO ALTO LLC v. LUPIN PHARMACEUTICALS, INC.2010-07-14

See all RANEXA litigation

Synonyms for RANEXA
(-)-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
(+/-)-Ranolazine
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
AC1L1M17
AC1Q5LYD
ACT06286
AK-72950
AKOS015889500
AN-5494
BC205445
BCP04190
BCP0726000090
BCP9000558
BDBM50173335
BR-72950
BRD-A97674275-001-01-9
BRD-A97674275-001-04-3
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
D05700
DB00243
DSSTox_CID_25196
DSSTox_GSID_45196
DSSTox_RID_80743
DTXSID3045196
FT-0601594
GTPL7291
H959
HMS1922F16
HMS2090L09
HMS2093D21
HMS2098K06
HMS2230C19
HMS3369I08
HMS3655M12
HMS3715K06
HSDB 7924
HY-B0280
I01-2008
I06-0160
KB-298373
KEG-1295
KS-00000JS7
KS-1244
Latixa
Lopac0_001062
LS-187267
MCULE-8182023610
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-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 (TN)
RANOLAZINE
Ranolazine (Ranexa)
Ranolazine (USAN/INN)
Ranolazine [USAN:INN:BAN]
Ranolazine 2HCl
RS 43285-003
RS-43285-003
S-1794
s1799
SB13209
SBI-0051032.P002
SC-25810
SCHEMBL124665
SMR000857382
SPECTRUM1505366
SR-01000076216
SR-01000076216-5
SR-01000076216-8
ST24025536
SW197620-4
Tox21_110258
Tox21_110258_1
TR-031802
XKLMZUWKNUAPSZ-UHFFFAOYSA-N
Z68563450
Paragraph IV (Patent) Challenges for RANEXA
Tradename Dosage Ingredient NDA Submissiondate
RANEXA TABLET, EXTENDED RELEASE;ORAL ranolazine 021526 2010-05-17

US Patents and Regulatory Information for RANEXA

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 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 AB RX Yes Yes   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

Expired US Patents for RANEXA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RANEXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 341 Finland   Start Trial
1109558 PA2008017 Lithuania   Start Trial PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558 C01109558/01 Switzerland   Start Trial FORMER OWNER: ROCHE PALTO ALTO LLC, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Harvard Business School
Mallinckrodt
Dow
Express Scripts

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