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Latanoprost - Generic Drug Details
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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 Pharma Global, Akorn, Amring Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Dr Reddys Labs Ltd, Fdc Ltd, Sandoz Inc, Somerset, Upjohn, and Aerie Pharms Inc, and is included in thirteen NDAs. There are seventeen 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for latanoprost
| International Patents: | 19 |
| US Patents: | 17 |
| Tradenames: | 5 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: | 20 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 170 |
| Patent Applications: | 6,801 |
| 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 |
|---|---|
| JeniVision, Inc. | Phase 1/Phase 2 |
| Shaimaa Fawzy Abdel-rady Abdel-latif | Phase 4 |
| Harvard University | Phase 1 |
Generic filers with tentative approvals for LATANOPROST
| Applicant | Application No. | Strength | Dosage Form |
| Get Started for $10 | Get Started for $10 | 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 |
Paragraph IV (Patent) Challenges for LATANOPROST
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XALATAN | SOLUTION/DROPS;OPHTHALMIC | latanoprost | 020597 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb | VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795-001 | Nov 2, 2017 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| Bausch And Lomb | VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795-001 | Nov 2, 2017 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Dr Reddys Labs Ltd | LATANOPROST | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 202077-001 | Feb 11, 2013 | AT | RX | No | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| >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 | Get Started for $10 | Get Started for $10 |
| Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | Get Started for $10 | Get Started for $10 |
| Upjohn | XALATAN | latanoprost | SOLUTION/DROPS;OPHTHALMIC | 020597-001 | Jun 5, 1996 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for latanoprost
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 6270384 | Get Started for $10 |
| Israel | 205095 | Get Started for $10 |
| South Korea | 101510185 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for latanoprost
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0364417 | C970039 | Netherlands | Get Started for $10 | 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 |
| 0364417 | SPC/GB97/014 | United Kingdom | Get Started for $10 | 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 | 9690031-1 | Sweden | Get Started for $10 | PRODUCT NAME: LATANOPROST |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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