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Last Updated: December 10, 2019

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Olopatadine hydrochloride - Generic Drug Details

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

Olopatadine hydrochloride is the generic ingredient in five branded drugs marketed by Akorn, Akorn Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Cipla, Fdc Ltd, Gland Pharma Ltd, Mylan, Somerset Theraps Llc, USV, Wockhardt Ltd, Zambon Spa, Novartis, and Perrigo Israel, and is included in twenty-four NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has fifty-nine patent family members in twenty-five countries.

There are seventeen drug master file entries for olopatadine hydrochloride. Twenty-four suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for olopatadine hydrochloride

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

SponsorPhase
Michael Marchand, MDPhase 4
Université de MontréalPhase 4
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPhase 4

See all olopatadine hydrochloride clinical trials

Recent Litigation for olopatadine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alcon Research, Ltd. v. Cipla Limited2017-08-31
Alcon Research, Ltd. v. Lupin Ltd.2017-03-24
Alcon Research Ltd. v. Apotex Inc.2016-10-06

See all olopatadine hydrochloride litigation

PTAB Litigation
PetitionerDate
Cipla Limited2018-06-05
Apotex, Inc.2016-08-18
Argentum Pharmaceuticals, LLC2016-02-02

See all olopatadine hydrochloride litigation

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.1%SOLUTION; OPHTHALMIC
  Start Trial  Start Trial0.2%SOLUTION;OPHTHALMIC
  Start Trial  Start Trial0.1%SOLUTION;OPHTHALMIC

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

Pharmacology for olopatadine hydrochloride
Medical Subject Heading (MeSH) Categories for olopatadine hydrochloride
Synonyms for olopatadine hydrochloride
(11Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride
(z)-11-(3-(dimethyl-amino)-propylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid
(Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic acid hydrochloride
(Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride ;Olopatadine HCL
(Z)-2-(11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic acid
(Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic acid hydrochloride
[(2Z)-2-[3-(dimethylamino)propylidene]-9-oxatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-5-yl]acetic acid
[(2Z)-2-[3-(dimethylamino)propylidene]-9-oxatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-5-yl]acetic acid hydrochloride
[11-(3-Dimethylamino-propylidene)-6,11-dihydro-dibenzo[b,e]oxepin-2-yl]-acetic acid; hydrochloride
{(11Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenzo[b,e]oxepin-2-yl}acetic acid
11-((Z)-3-(Dimethyl-amino)propylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid
11-((Z)-3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid
11-((Z)-3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid hydrochloride
11-((Z)-3-(Dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid, hydrochloride
11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic acid
113806-05-6
113806-05-6 (Parent)
140462-76-6
140462-76-6 (hydrochloride)
2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid
2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride
2-[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid;hydrochloride
2-[(2Z)-2-[3-(dimethylamino)propylidene]-9-oxatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-5-yl]acetic acid
2XG66W44KF
806O056
AB00698500_11
AB00698500-07
AB00698500-09
AB00698500-10
AB0107085
AB2000599
AC1NQXZH
AC1NR00D
AKOS005557129
AKOS015895232
AKOS025149118
AKOS025149450
AKOS026750048
AL-4943A
Allelock
Allelock (TN)
ALO 4943A
ALO-4943A
ALO4943A
AM84372
AN-33374
API0005265
BCP12203
BCP9001022
BDBM50002096
BIDD:GT0285
BRD-K37130586-003-01-3
BRD-K67637637-003-12-6
C-21208
C07789
CAS-140462-76-6
CCG-101141
CHEBI:31933
CHEBI:94593
CHEMBL1189432
CHEMBL1719
CPD000469220
CS-0053963
CS-2532
D01192
D08293
D27V6190PM
DB00768
DE 114
Dibenz(b,e)oxepin-2-acetic acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, hydrochloride, (Z)-
Dibenz(b,e)oxepin-2-acetic acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, hydrochloride, (Z)-
DSSTox_CID_26486
DSSTox_GSID_46486
DSSTox_RID_81657
DTXSID0046486
DTXSID3023390
EX-A1347
FT-0082377
GTPL7249
H06O056
HCl of KW 4679
HMS2089K10
HVRLZEKDTUEKQH-NOILCQHBSA-N
HY-B0426A
JBIMVDZLSHOPLA-LSCVHKIXSA-N
KS-1228
KW 4679
KW-4679
KW-4943A
KW4679
L000748
LS-172239
LS-61598
MFCD00875716
MLS001401465
MLS006011811
MolPort-003-986-254
MolPort-003-986-408
NC00391
NCGC00164623-01
NCGC00263532-01
O-PPDS
O0361
Olopatadin
Olopatadina
Olopatadine
Olopatadine (hydrochloride)
Olopatadine (INN)
Olopatadine [INN:BAN]
OLOPATADINE HCl
Olopatadine Hydrochlorde
Olopatadine hydrochloride (JP17/USAN)
Olopatadine hydrochloride (Opatanol)
Olopatadine hydrochloride [USAN:USP]
Olopatadine hydrochloride tablets (JP17)
Olopatadine hydrochloride, >=98% (HPLC)
Olopatadine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Olopatadinum
Olopax
Olopine
Opatanol
Opatanol (TN)
Opatanol;Pataday;Patanase;Allelock
Pataday
Patadine
Patanase
Patanol
Patanol (TN)
Pazeo
PubChem18816
Q-201511
s2494
SAM001246802
SB10717
SCHEMBL23213
SCHEMBL4668
SMR000469220
SMR004703490
SR-01000763388
SR-01000763388-3
SR-01000763388-4
STK624184
TL8000403
TL8000904
Tox21_112242
Tox21_112242_1
UNII-2XG66W44KF
UNII-D27V6190PM
ZINC1850
Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PAZEO SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 206276 2015-09-10
PATANASE SPRAY, METERED;NASAL olopatadine hydrochloride 021861 2009-06-29
PATADAY SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 021545 2008-09-08
PATANOL SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 020688 2006-07-17

US Patents and Regulatory Information for olopatadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Somerset Theraps Llc OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206306-001 Dec 7, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 209995-001 Apr 4, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd OLOPATADINE HYDROCHLORIDE olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204812-001 Dec 18, 2015 AT 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 olopatadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATADAY olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021545-001 Dec 22, 2004   Start Trial   Start Trial
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861-001 Apr 15, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for olopatadine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0799044 02C0040 France   Start Trial PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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