LATANOPROST - Generic Drug Details

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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, 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

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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
Sandoz	LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	091449-001	Mar 22, 2011	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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

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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	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
San Marino	T201400098	Sistema di rilascio polimerico di una soluzione non viscosa a base prostaglandina senza conservante	⤷ Sign Up
China	101835473		⤷ Sign Up
South Korea	101809713		⤷ Sign Up
Japan	5877885		⤷ Sign Up
Japan	5657789		⤷ Sign Up
>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
3461484	C202130024	Spain	⤷ Sign Up	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	97C0111	Belgium	⤷ Sign Up	PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
3461484	SPC/GB21/033	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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