Latanoprost - Generic Drug Details

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:	7,439
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

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
		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

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			Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes			Y	Y
Bausch And Lomb	VYZULTA	latanoprostene bunod	SOLUTION/DROPS;OPHTHALMIC	207795-001	Nov 2, 2017		RX	Yes	Yes			Y	Y
Sandoz	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	091449-001	Mar 22, 2011	AT	RX	No	No
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Carnegie	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	202077-001	Feb 11, 2013	AT	RX	No	No
Apotex Inc	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	077697-001	Mar 22, 2011		DISCN	No	No

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
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996

International Patents for latanoprost

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2197449
Poland	2588078
Mexico	2012014503	SISTEMA POLIMERICO PARA SUMINISTRAR UNA SOLUCION NO VISCOSA A BASE DE PROSTAGLANDINA, SIN CONSERVADORES. (POLYMERIC SYSTEM FOR DELIVERING A PRESERVATIVE-FREE PROSTAGLANDIN-BASED NONVISCOUS SOLUTION.)
New Zealand	584555	STABILISED OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN AND A POLYETHYLENE GLYCOL HYDROXYSTEARATE SUCH AS SOLUTOL HS 15
Colombia	6270384	COMPOSICIONES OFTALMICAS QUE COMPRENDEN DERIVADOS DE PROSTAGLANDINA
China	101835473
Chile	2012003684	Una solucion oftalmica que incluye por lo menos una prostaglandina, un agente solubilizador, un agente gelificador carbomero, un agente inhibidor de la polimerizacion del carbomero y un agente co-gelificador/co-solubilizador, la cual tiene una viscosidad entre 8 y 20 mpa.s y no contiene conservadores antimicrobianos; y frasco que la comprende.

Supplementary Protection Certificates for latanoprost

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	97C0128	France		PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
3461484	C202130024	Spain		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
3461484	301101	Netherlands		PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108
0364417	C970039	Netherlands		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	61/1997	Austria		PRODUCT NAME: LATANOPROST UND SEINE THERAPEUTISCH AKTIVEN UND PHYSIOLOGISCH ANNEHMBAREN DERIVATE; NAT. REGISTRATION NO/DATE: 1-22019 19970627; FIRST REGISTRATION: SE 12716 19960718
0364417	SPC/GB97/014	United Kingdom		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
3461484	SPC/GB21/033	United Kingdom		PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107