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Last Updated: April 27, 2024

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 six branded drugs marketed by Sun Pharm, Thea Pharma, Amring Pharms, Apotex Inc, Bausch And Lomb, Carnegie, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Sandoz, Somerset, Upjohn, and Alcon Labs Inc, and is included in fourteen NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Latanoprost has fifty-three patent family members in thirty-one countries.

There are twenty drug master file entries for latanoprost. Twelve 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
DataPharm Australia, CMAX Clinical Research, Agilex AustraliaPhase 1
Aneira Pharma, Inc.Phase 1
Uzoma Chinyei JoanPhase 4

See all latanoprost clinical trials

Generic filers with tentative approvals for LATANOPROST
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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
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
Somerset LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 201786-001 Mar 22, 2011 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb VYZULTA latanoprostene bunod SOLUTION/DROPS;OPHTHALMIC 207795-001 Nov 2, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Carnegie LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 202077-001 Feb 11, 2013 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for latanoprost

Country Patent Number Title Estimated Expiration
Colombia 6660508 Sistema polimérico para suministrar una solución no viscosa a base de prostaglandina, sin conservadores ⤷  Try a Trial
Poland 2588078 ⤷  Try a Trial
Australia 2008344909 ⤷  Try a Trial
New Zealand 584555 STABILISED OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN AND A POLYETHYLENE GLYCOL HYDROXYSTEARATE SUCH AS SOLUTOL HS 15 ⤷  Try a Trial
South Korea 20100087107 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for latanoprost

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3461484 21C1024 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3461484 301101 Netherlands ⤷  Try a Trial PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3461484 132021000000068 Italy ⤷  Try a Trial PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3461484 122021000036 Germany ⤷  Try a Trial PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
0364417 SPC/GB97/014 United Kingdom ⤷  Try a 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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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 verification 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.