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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cerilliant
QuintilesIMS
McKinsey
Chubb
Dow
Medtronic
Covington
McKesson

Generated: July 22, 2018

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 fourteen 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:14
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 N 54092-606-01
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Shire US Manufacturing Inc. 54092-606 N 54092-606-02

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:➤ Try a Free TrialPatent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent 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 hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Moodys
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Fish and Richardson
Healthtrust
Express Scripts

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 verifification 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.