LATANOPROST - Generic Drug Details

What are the generic drug sources for latanoprost and what is the scope of patent protection?

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

See drug sales revenues for LATANOPROST

Recent Clinical Trials for LATANOPROST

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

Sponsor	Phase
DataPharm Australia, CMAX Clinical Research, Agilex Australia	Phase 1
Aneira Pharma, Inc.	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

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
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472-001	Dec 13, 2022		RX	Yes	Yes			Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes			Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes
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
Eugia Pharma	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	206519-001	Sep 3, 2019		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
Portugal	2588078
New Zealand	584555	STABILISED OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN AND A POLYETHYLENE GLYCOL HYDROXYSTEARATE SUCH AS SOLUTOL HS 15
Brazil	112012033435	solução oftálmica e frasco de dose única ou multi-dose feito de pebd sem aditivos.
Tunisia	2012000588	SYSTEME DE DELIVRANCE POLYMERIQUE D'UNE SOLUTION NON VISQUEUSE A BASE DE PROSTAGLANDINE SANS CONSERVATEUR
Canada	2702478	COMPOSITION OPHTALMOLOGIQUE (OPHTHALMIC COMPOSITION)
Japan	2013532159

Supplementary Protection Certificates for LATANOPROST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	9690031-1	Sweden		PRODUCT NAME: LATANOPROST
3461484	132021000000068	Italy		PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3461484	21C1024	France		PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
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
0364417	97C0128	France		PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
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