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 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 |
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 |
Generic filers with tentative approvals for LATANOPROST
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 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
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Aerie Pharms Inc | ROCKLATAN | latanoprost; netarsudil dimesylate | SOLUTION/DROPS;OPHTHALMIC | 208259-001 | Mar 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | AT | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Apotex Inc | LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 077697-001 | Mar 22, 2011 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Eugia Pharma | LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 206519-001 | Sep 3, 2019 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Somerset | LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 201786-001 | Mar 22, 2011 | AT | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | See Plans and Pricing | See Plans and Pricing |
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | See Plans and Pricing | See Plans and Pricing |
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | See Plans and Pricing | See Plans and Pricing |
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | See Plans and Pricing | See Plans and Pricing |
Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for latanoprost
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201002615 | OPHTHALMIC COMPOSITION COMPRISING A PROSTAGLANDIN | See Plans and Pricing |
Colombia | 6270384 | COMPOSICIONES OFTALMICAS QUE COMPRENDEN DERIVADOS DE PROSTAGLANDINA | See Plans and Pricing |
European Patent Office | 2197449 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2009084021 | See Plans and Pricing | |
Australia | 2008344909 | See Plans and Pricing | |
Canada | 2702478 | COMPOSITION OPHTALMOLOGIQUE (OPHTHALMIC COMPOSITION) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for latanoprost
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0364417 | 97C0128 | France | See Plans and Pricing | PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718 |
0364417 | C970039 | Netherlands | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: ROCLANDA - LATANOPROST / NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/20/1502 20210108 |
3461484 | C202130024 | Spain | See Plans and Pricing | 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 | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.