Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKinsey
Harvard Business School
McKesson
Medtronic

Last Updated: May 26, 2022

Details for New Drug Application (NDA): 208073


✉ Email this page to a colleague

« Back to Dashboard

NDA 208073 describes XIIDRA, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the XIIDRA profile page.

The generic ingredient in XIIDRA is lifitegrast. Two suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
Summary for 208073
Tradename:XIIDRA
Applicant:Novartis
Ingredient:lifitegrast
Patents:16
DrugPatentWatch® Estimated 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 Novartis Pharmaceuticals Corporation 0078-0911 0078-0911-12 12 POUCH in 1 CARTON (0078-0911-12) > 5 AMPULE in 1 POUCH (0078-0911-05) > .2 mL in 1 AMPULE
XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073 NDA Novartis Pharmaceuticals Corporation 0078-0911 0078-0911-94 4 POUCH in 1 CARTON (0078-0911-94) > 5 AMPULE in 1 POUCH (0078-0911-95) > .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
Patent:See Plans and PricingPatent Expiration:Nov 5, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:See Plans and PricingPatent Expiration:Dec 18, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Mar 10, 2025Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Harvard Business School
Colorcon
Johnson and Johnson
Medtronic

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.