Details for New Drug Application (NDA): 208073
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NDA 208073 describes XIIDRA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are sixteen 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.
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: | Novartis |
| Ingredient: | lifitegrast |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
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: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 5% | ||||
| Approval Date: | Jul 11, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 5, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 10, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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