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Last Updated: May 6, 2021

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LATANOPROST - Generic Drug Details

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What are the generic drug 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, Sandoz Inc, Somerset, Upjohn, and Aerie Pharms Inc, and is included in thirteen NDAs. There are seventeen 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. Thirteen 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

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

SponsorPhase
JeniVision, Inc.Phase 1/Phase 2
Shaimaa Fawzy Abdel-rady Abdel-latifPhase 4
Harvard UniversityPhase 1

See all LATANOPROST clinical trials

Generic filers with tentative approvals for LATANOPROST
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $100.005%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
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
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Dr Reddys Labs Ltd LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 202077-001 Feb 11, 2013 AT RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Apotex Inc LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 077697-001 Mar 22, 2011 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Get Started for $10   Get Started for $10
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Get Started for $10   Get Started for $10
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Get Started for $10   Get Started for $10
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Get Started for $10   Get Started for $10
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996   Get Started for $10   Get Started for $10
>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 C970039 Netherlands   Get Started for $10 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 SPC/GB97/014 United Kingdom   Get Started for $10 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
0364417 9690031-1 Sweden   Get Started for $10 PRODUCT NAME: LATANOPROST
0364417 61/1997 Austria   Get Started for $10 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   Get Started for $10 PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
0364417 97C0128 France   Get Started for $10 PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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