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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Ranolazine - Generic Drug Details

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

Ranolazine is the generic ingredient in two branded drugs marketed by Gilead, Actavis Elizabeth, Ajanta Pharma Ltd, Cadila, Cipla, Glenmark Pharms Ltd, Lupin Ltd, Sciegen Pharms Inc, and Sun Pharm, and is included in nine NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for ranolazine

See drug prices for ranolazine

Recent Clinical Trials for ranolazine

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

SponsorPhase
University of Kansas Medical CenterPhase 2
TSH Biopharm Corporation LimitedN/A
Elpen Pharmaceutical Co. Inc.Phase 2/Phase 3

See all ranolazine clinical trials

Recent Litigation for ranolazine

Identify potential future generic entrants

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 ranolazine litigation

Generic filers with tentative approvals for RANOLAZINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1000MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GMTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for ranolazine
Synonyms for 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
(+/-)-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
Ranexa (TN)
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 RANOLAZINE
Tradename Dosage Ingredient NDA Submissiondate
RANEXA TABLET, EXTENDED RELEASE;ORAL ranolazine 021526 2010-05-17

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
Actavis Elizabeth RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 208862-002 May 28, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-001 Feb 12, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526-002 Jan 27, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd RANOLAZINE ranolazine TABLET, EXTENDED RELEASE;ORAL 210054-001 May 28, 2019 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

Expired US Patents for ranolazine

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1109558 SZ 1/2009 Austria   Start Trial PRODUCT NAME: RANOLAZIN ODER EIN SALZ ODER SOLVAT DAVON
1109558 PA2008017,C1109558 Lithuania   Start Trial PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
1109558 CA 2008 00051 Denmark   Start Trial PRODUCT NAME: RANOLAZIN ELLER ET SALT DERAF
1109558 SPC/GB08/058 United Kingdom   Start Trial PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714
1109558 300371 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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