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Serving leading biopharmaceutical companies globally:

Deloitte
Novartis
US Army
Queensland Health
McKinsey
Covington
McKesson
Daiichi Sankyo
Cipla
Citi

Generated: October 22, 2017

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 thirteen 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 NDA: 208073

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:13

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

Summary 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:► SubscribePatent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Nov 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)


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Serving leading biopharmaceutical companies globally:

Teva
Harvard Business School
Daiichi Sankyo
Fish and Richardson
Federal Trade Commission
Farmers Insurance
Colorcon
Argus Health
AstraZeneca
Cantor Fitzgerald

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