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Last Updated: June 27, 2022

Latanoprost - Generic Drug Details


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What are the generic drug sources for latanoprost and what is the scope of freedom to operate?

Latanoprost is the generic ingredient in five branded drugs marketed by Sun Pharm, Akorn, Amring Pharms, Apotex Inc, Bausch And Lomb, Dr Reddys Labs Ltd, Eugia Pharma, Fdc Ltd, Sandoz Inc, Somerset, Upjohn, and Aerie Pharms Inc, and is included in thirteen NDAs. There are twenty-one 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. Eleven 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
Aerie PharmaceuticalsPhase 4
TearClear CorpPhase 3
Laboratoires TheaPhase 4

See all latanoprost clinical trials

Generic filers with tentative approvals for LATANOPROST
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.005%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
Anatomical Therapeutic Chemical (ATC) Classes for latanoprost

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
Sun Pharm XELPROS latanoprost EMULSION;OPHTHALMIC 206185-001 Sep 12, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aerie Pharms Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 AT RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 077697-001 Mar 22, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 206519-001 Sep 3, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Somerset LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 201786-001 Mar 22, 2011 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 See Plans and Pricing See Plans and Pricing
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 See Plans and Pricing See Plans and Pricing
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 See Plans and Pricing See Plans and Pricing
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for latanoprost

Country Patent Number Title Estimated Expiration
South Africa 201002615 OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN See Plans and Pricing
Colombia 6270384 COMPOSICIONES OFTALMICAS QUE COMPRENDEN DERIVADOS DE PROSTAGLANDINA See Plans and Pricing
European Patent Office 2197449 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009084021 See Plans and Pricing
Australia 2008344909 See Plans and Pricing
Canada 2702478 COMPOSITION OPHTALMOLOGIQUE (OPHTHALMIC COMPOSITION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for latanoprost

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0364417 97C0128 France See Plans and Pricing PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
0364417 C970039 Netherlands See Plans and Pricing 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
3461484 2021C/515 Belgium See Plans and Pricing PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108
3461484 C202130024 Spain See Plans and Pricing PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107
0364417 SPC/GB97/014 United Kingdom See Plans and Pricing 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 97C0111 Belgium See Plans and Pricing PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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