Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206185

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NDA 206185 describes XELPROS, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the XELPROS profile page.

The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 206185
Tradename:XELPROS
Applicant:Sun Pharma Global
Ingredient:latanoprost
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 206185
Suppliers and Packaging for NDA: 206185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XELPROS latanoprost EMULSION;OPHTHALMIC 206185 NDA Sun Pharmaceutical Industries, Inc. 47335-317 47335-317-90 1 BOTTLE, DROPPER in 1 BOX (47335-317-90) > 2.5 mL in 1 BOTTLE, DROPPER
XELPROS latanoprost EMULSION;OPHTHALMIC 206185 NDA Sun Pharmaceutical Industries, Inc. 47335-317 47335-317-92 3 BOTTLE, DROPPER in 1 BOX (47335-317-92) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;OPHTHALMICStrength0.005%
Approval Date:Sep 12, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 15, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCING ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Patent:  Start TrialPatent Expiration:Sep 12, 2029Product Flag?YSubstance Flag?Delist Request?

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Moodys

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