DrugPatentWatch Database Preview
XIIDRA Drug Profile
» See Plans and Pricing
Which patents cover Xiidra, and when can generic versions of Xiidra launch?
Xiidra is a drug marketed by Novartis and is included in one NDA. There are fifteen patents protecting this drug.
This drug has one hundred and twenty patent family members in twenty-one countries.
The generic ingredient in XIIDRA is lifitegrast. Two suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.
DrugPatentWatch® Generic Entry Outlook for Xiidra
Xiidra was eligible for patent challenges on July 11, 2020.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 15, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XIIDRA
| International Patents: | 120 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 30 |
| Clinical Trials: | 9 |
| Patent Applications: | 223 |
| Drug Prices: | Drug price information for XIIDRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XIIDRA |
| What excipients (inactive ingredients) are in XIIDRA? | XIIDRA excipients list |
| DailyMed Link: | XIIDRA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XIIDRA
Generic Entry Date for XIIDRA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for XIIDRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Surface Pharmaceuticals, Inc. | Phase 2 |
| Novartis Pharmaceuticals | Phase 2 |
| Eye Surgeons of Indiana | Phase 4 |
Pharmacology for XIIDRA
| Drug Class | Lymphocyte Function-Associated Antigen-1 Antagonist |
| Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
Paragraph IV (Patent) Challenges for XIIDRA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XIIDRA | SOLUTION/DROPS;OPHTHALMIC | lifitegrast | 208073 | 2020-07-13 |
US Patents and Regulatory Information for XIIDRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | XIIDRA | lifitegrast | SOLUTION/DROPS;OPHTHALMIC | 208073-001 | Jul 11, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for XIIDRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2209371 | Start Trial |
| Japan | 5840582 | Start Trial |
| Japan | 2020128433 | Start Trial |
| European Patent Office | 1682537 | Start Trial |
| Japan | 2012107057 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XIIDRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2444079 | C02444079/01 | Switzerland | Start Trial | PRODUCT NAME: LIFITEGRAST; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66850 19.12.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
