Latanoprost - Generic Drug Details

✉ Email this page to a colleague

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, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Ryan Labs, Sandoz, Somerset, Upjohn, and Alcon Labs Inc, and is included in fourteen NDAs. There are twenty-four 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for latanoprost

International Patents:	53
US Patents:	24
Tradenames:	6
Applicants:	13
NDAs:	14
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	191
Patent Applications:	7,439
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
Peregrine Ophthalmic	Phase 1

See all latanoprost clinical trials

Generic filers with tentative approvals for LATANOPROST

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ryan Labs	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	202077-001	Feb 11, 2013	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fdc Ltd	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	202442-001	Apr 22, 2016	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	201006-001	Mar 22, 2011	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	206519-001	Sep 3, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	⤷ Sign Up	⤷ Sign Up
Upjohn	XALATAN	latanoprost	SOLUTION/DROPS;OPHTHALMIC	020597-001	Jun 5, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for latanoprost

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	104274396	POLYMERIC SYSTEM FOR DELIVERING A PRESERVATIVE-FREE PROSTAGLANDIN-BASED NONVISCOUS SOLUTION	⤷ Sign Up
Australia	2008344909		⤷ Sign Up
Israel	205095		⤷ Sign Up
Brazil	PI0818459		⤷ Sign Up
China	102958509	Polymeric system for delivering preservative-free prostaglandin-based nonviscous solution	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for latanoprost

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3461484	122021000036	Germany	⤷ Sign Up	PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
3461484	132021000000068	Italy	⤷ Sign Up	PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
0364417	61/1997	Austria	⤷ Sign Up	PRODUCT NAME: LATANOPROST UND SEINE THERAPEUTISCH AKTIVEN UND PHYSIOLOGISCH ANNEHMBAREN DERIVATE; NAT. REGISTRATION NO/DATE: 1-22019 19970627; FIRST REGISTRATION: SE 12716 19960718
3461484	2021C/515	Belgium	⤷ Sign Up	PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108
0364417	97C0128	France	⤷ Sign Up	PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.