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Last Updated: May 20, 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.

Summary for latanoprost

International Patents:	53
US Patents:	23
Tradenames:	6
Applicants:	13
NDAs:	14
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	190
Patent Applications:	7,181
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for latanoprost
Drug Sales Revenues:	Drug sales revenues for latanoprost
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for latanoprost
What excipients (inactive ingredients) are in latanoprost?	latanoprost excipients list
DailyMed Link:	latanoprost at DailyMed

See drug prices for latanoprost

Drug Sales Revenue Trends for latanoprost

See drug sales revenues for latanoprost

Recent Clinical Trials for latanoprost

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

Sponsor	Phase
Aneira Pharma, Inc.	Phase 1
DataPharm Australia, CMAX Clinical Research, Agilex Australia	Phase 1
Uzoma Chinyei Joan	Phase 4

See all latanoprost clinical trials

Generic filers with tentative approvals for LATANOPROST

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.005%	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

Drug Class	Prostaglandin Analog

Anatomical Therapeutic Chemical (ATC) Classes for latanoprost

S01EE	Prostaglandin analogues
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for latanoprost

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial		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	Y			⤷ Try a Trial
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472-001	Dec 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	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	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
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amring Pharms	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	200925-001	Mar 22, 2011	AT	RX	No	No	⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20130112728	POLYMERIC SYSTEM FOR DELIVERING A PRESERVATIVE-FREE PROSTAGLANDING-BASED NONVISCOUS SOLUTION	⤷ Try a Trial
Japan	5657789		⤷ Try a Trial
Brazil	112012033435	solução oftálmica e frasco de dose única ou multi-dose feito de pebd sem aditivos.	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2012001009		⤷ Try a Trial
Denmark	2588078		⤷ Try a Trial
France	2961694	SYSTEME DE DELIVRANCE POLYMERIQUE D'UNE SOLUTION NON VISQUEUSE A BASE DE PROSTAGLANDINE SANS CONSERVATEUR	⤷ Try a Trial
Singapore	186361	POLYMERIC SYSTEM FOR DELIVERING A PRESERVATIVE-FREE PROSTAGLANDIN-BASED NONVISCOUS SOLUTION	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for latanoprost

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	9690031-1	Sweden	⤷ Try a Trial	PRODUCT NAME: LATANOPROST
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
0364417	97C0111	Belgium	⤷ Try a Trial	PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
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
0364417	61/1997	Austria	⤷ Try a Trial	PRODUCT NAME: LATANOPROST UND SEINE THERAPEUTISCH AKTIVEN UND PHYSIOLOGISCH ANNEHMBAREN DERIVATE; NAT. REGISTRATION NO/DATE: 1-22019 19970627; FIRST REGISTRATION: SE 12716 19960718
3461484	SPC/GB21/033	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107
>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.