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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208073

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NDA 208073 describes XIIDRA, which is a drug marketed by Shire Dev Llc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the XIIDRA profile page.

The generic ingredient in XIIDRA is lifitegrast. One supplier is listed for this compound. Additional details are available on the lifitegrast profile page.
Summary for 208073
Tradename:XIIDRA
Applicant:Shire Dev Llc
Ingredient:lifitegrast
Patents:15
Generic Entry Opportunity Date for 208073
Generic Entry Date for 208073*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208073
Suppliers and Packaging for NDA: 208073
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Shire US Manufacturing Inc. 54092-606 54092-606-01 12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Shire US Manufacturing Inc. 54092-606 54092-606-02 12 POUCH in 1 CARTON (54092-606-02) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength5%
Approval Date:Jul 11, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 11, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Nov 5, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:  Start TrialPatent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?

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