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XIIDRA Drug Profile
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» See Plans and PricingWhich 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 twelve 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.
US ANDA Litigation and Generic Entry Outlook for Xiidra
Xiidra will be eligible for patent challenges on July 11, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 112 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 25 |
| Clinical Trials: | 7 |
| Patent Applications: | 52 |
| Drug Prices: | Drug price information for XIIDRA |
| DailyMed Link: | XIIDRA at DailyMed |
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 |
|---|---|
| Novartis Pharmaceuticals | Phase 2 |
| University of Waterloo | Phase 4 |
| Novartis | Phase 4 |
Pharmacology for XIIDRA
| Drug Class | Lymphocyte Function-Associated Antigen-1 Antagonist |
| Mechanism of Action | Lymphocyte Function-Associated Antigen-1 Antagonists |
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 | 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 | Y | 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 |
|---|---|---|
| Japan | 2016128515 | Start Trial |
| Slovenia | 2444079 | Start Trial |
| Spain | 2383525 | Start Trial |
| Japan | 6607780 | Start Trial |
| Japan | 2014133751 | Start Trial |
| Japan | 2011516607 | Start Trial |
| Canada | 2960117 | 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 |
