Details for New Drug Application (NDA): 208073
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NDA 208073 describes XIIDRA, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the XIIDRA profile page.
The generic ingredient in XIIDRA is lifitegrast. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
The generic ingredient in XIIDRA is lifitegrast. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
Summary for 208073
| Tradename: | XIIDRA |
| Applicant: | Bausch And Lomb Inc |
| Ingredient: | lifitegrast |
| Patents: | 11 |
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: | ⤷ Start Trial | Patent Expiration: | Dec 18, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 25, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | May 17, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 208073
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch And Lomb Inc | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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