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 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.

Summary for latanoprost

International Patents:	19
US Patents:	21
Tradenames:	5
Applicants:	12
NDAs:	13
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	185
Patent Applications:	6,636
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
Aerie Pharmaceuticals	Phase 4
TearClear Corp	Phase 3
Laboratoires Thea	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
Aerie Pharms Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	AT	RX	Yes	Yes
Apotex Inc	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	077697-001	Mar 22, 2011		DISCN	No	No
Eugia Pharma	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	206519-001	Sep 3, 2019		DISCN	No	No
Somerset	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	201786-001	Mar 22, 2011	AT	RX	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
South Africa	201002615	OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN
Colombia	6270384	COMPOSICIONES OFTALMICAS QUE COMPRENDEN DERIVADOS DE PROSTAGLANDINA
European Patent Office	2197449
World Intellectual Property Organization (WIPO)	2009084021
Australia	2008344909
Canada	2702478	COMPOSITION OPHTALMOLOGIQUE (OPHTHALMIC COMPOSITION)

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
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
3461484	2021C/515	Belgium		PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND 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	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
0364417	97C0111	Belgium		PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071