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Last Updated: December 5, 2019

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Latanoprost - Generic Drug Details

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

Latanoprost is the generic ingredient in five branded drugs marketed by Sun Pharma Global, Akorn, Amring Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Dr Reddys Labs Ltd, Fdc Ltd, Mylan, Sandoz Inc, Pharmacia And Upjohn, and Aerie Pharms Inc, and is included in thirteen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprost has nineteen patent family members in seventeen countries.

There are twenty drug master file entries for latanoprost. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for latanoprost

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Drug Sales Revenue Trends for latanoprost

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Recent Clinical Trials for latanoprost

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SponsorPhase
PolyActiva Pty LtdPhase 1
Icahn School of Medicine at Mount SinaiPhase 4
Universiti Kebangsaan Malaysia Medical CentrePhase 4

See all latanoprost clinical trials

Recent Litigation for latanoprost

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan, Inc. v. Sandoz, Inc.2015-10-19
Allergan Inc. v. Barr Laboratories Inc.2009-05-07
Alcon Research Ltd. v. Barr Laboratories Inc.2009-04-30

See all latanoprost litigation

Generic filers with tentative approvals for LATANOPROST
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.005%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 latanoprost
Synonyms for latanoprost
(15R)-Latanoprost
(5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptanoic acid 1-methylethyl ester
(5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid 1-Methylethyl Ester
(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic acid propan-2-yl ester
(Z)-isopropyl 7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((R)-3-hydroxy-5-phenylpentyl)cyclopentyl)hept-5-enoate
130209-82-4
155551-81-8
209L824
33537-EP2295409A1
33537-EP2311820A1
5-Heptenoic acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl ester
5-Heptenoic acid, 7-(3,5-dihydroxy-2-(3-hydroxy-5-phenylpentyl)cyclopentyl)-, 1-methylethyl ester, (1R-(1-alpha(Z),2-beta(R*),3-alpha,5-alpha))-
6Z5B6HVF6O
A806039
AB00640005-04
AB00640005-06
AB2000019
ABP001061
AC1NSK8Q
AKOS024458331
AR-202
AT-3016
BDBM50240648
C26H40O5
Catioprost
CCG-100946
CHEBI:6384
CHEMBL1051
CPD000466354
CS-2758
D00356
DB00654
DTXSID1041057
EX-A1770
GAAP Ofteno
GGXICVAJURFBLW-CEYXHVGTSA-N
GTPL1961
HMS2051H11
HMS2089J17
HMS3715N22
HY-B0577
Isopropyl (5Z,9alpha,11alpha,15R)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinor-prost-5-en-1-oate
isopropyl (5Z,9alpha,11alpha,15R)-9,11,15-trihydroxy-17-phenyl-18,19,20-trinorprost-5-en-1-oate
Isopropyl (Z)-7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((3R)-3-hydroxy-5-phenylpentyl)cyclopentyl)-5-heptenoate
Isopropyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate
Isopropyl 7-((1R,2R,3R,5S)-3,5-dihydroxy-2-((R)-3-hydroxy-5-phenylpentyl)cyclopentyl)hept-5-enoate
Isopropyl-(Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate
J-005764
Jsp001835
L-PPDS
L0262
latanoprost (isopropyl ester)
Latanoprost (JAN/USAN/INN)
Latanoprost [USAN:INN:BAN]
Latanoprost, (+/-)-
Latanoprost, >=98% (HPLC), oil
Latanoprost, United States Pharmacopeia (USP) Reference Standard
latanoprostum
MFCD00216074
MLS000759468
MLS001424106
MolPort-003-942-862
NC00196
NCGC00246969-01
Nova-21027
PhXA 41
PHXA-41
PhXA34 [as 15(R,S)-isomer]
PhXA41
propan-2-yl (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate
propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-bis(oxidanyl)-2-[(3R)-3-oxidanyl-5-phenyl-pentyl]cyclopentyl]hept-5-enoate
propan-2-yl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate
s4709
SAM001246671
SC-18987
SCHEMBL24698
SMR000466354
SR-01000759428
SR-01000759428-4
ST24047444
T-2345
TL8000716
Tris(2,4-dimethylphenyl)phosphine-5,5',5""""-trisulfonic acid trisodium salt
UNII-6Z5B6HVF6O
UNII-8S5FB3XXG8 component GGXICVAJURFBLW-CEYXHVGTSA-N
XA 41
XA-41
XA41
Xalatan
Xalatan (TN)
ZINC12468792
Paragraph IV (Patent) Challenges for LATANOPROST
Tradename Dosage Ingredient NDA Submissiondate
XALATAN SOLUTION/DROPS;OPHTHALMIC latanoprost 020597

US Patents and Regulatory Information for latanoprost

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 201786-001 Mar 22, 2011 AT RX No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Sandoz Inc LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 091449-001 Mar 22, 2011 AT RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 206519-001 Sep 3, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Amring Pharms LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 200925-001 Mar 22, 2011 AT RX No No   Start Trial   Start Trial   Start Trial
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   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 latanoprost

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Start Trial   Start Trial
Pharmacia And Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Start Trial   Start Trial
Pharmacia And Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Start Trial   Start Trial
Pharmacia And Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Start Trial   Start Trial
Pharmacia And Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for latanoprost

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0364417 61/1997 Austria   Start Trial PRODUCT NAME: LATANOPROST UND SEINE THERAPEUTISCH AKTIVEN UND PHYSIOLOGISCH ANNEHMBAREN DERIVATE; NAT. REGISTRATION NO/DATE: 1-22019 19970627; FIRST REGISTRATION: SE 12716 19960718
0364417 97C0111 Belgium   Start Trial PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
0364417 97C0128 France   Start Trial PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
0364417 C970039 Netherlands   Start Trial PRODUCT NAME: [1R-[1 ALPHA (Z),2 BETA(R*),3 ALPHA,5ALPHA]]-7-[3,5-DIHYDROXY-2-(3-HYDROXY-5- FENYLPENTYL)CYCLOPENTYL]-5-HEPTEENZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN ESTER, IN HET BIJZONDER LATANOPROSTUM; NAT. REGISTRATION NO/DATE: RVG 21304 19970610; FIRST REGISTRATION: SE 12716 19960718
0364417 9690031-1 Sweden   Start Trial PRODUCT NAME: LATANOPROST
0364417 SPC/GB97/014 United Kingdom   Start Trial PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Colorcon
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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.