Xiidra is a drug owned by Bausch And Lomb Inc. It is protected by 16 US drug patents filed from 2016 to 2021. Out of these, 11 drug patents are active and 5 have expired. Xiidra's patents have been open to challenges since 11 July, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 18, 2033. Details of Xiidra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9890141 | Crystalline pharmaceutical and methods of preparation and use thereof |
Oct, 2030
(5 years from now) | Active |
| US8084047 | Compositions and methods for treatment of eye disorders |
May, 2026
(1 year, 5 months from now) | Active |
| US7314938 | Modulators of cellular adhesion |
Mar, 2025
(3 months from now) | Active |
| US7928122 | Modulators of cellular adhesion |
Nov, 2024
(10 days ago) |
Expired
|
| US7745460 | Modulators of cellular adhesion |
Nov, 2024
(10 days ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11058677 | LFA-1 inhibitor formulations |
Dec, 2033
(9 years from now) | Active |
| US9085553 | LFA-1 inhibitor and methods of preparation and polymorph thereof |
Jul, 2033
(8 years from now) | Active |
| US8927574 | Crystalline pharmaceutical and methods of preparation and use thereof |
Nov, 2030
(5 years from now) | Active |
| US9353088 | Crystalline pharmaceutical and methods of preparation and use thereof |
Oct, 2030
(5 years from now) | Active |
| US8168655 | Compositions and methods for treatment of eye disorders |
May, 2029
(4 years from now) | Active |
| US8367701 | Crystalline pharmaceutical and methods of preparation and use thereof |
Apr, 2029
(4 years from now) | Active |
| US9447077 | Crystalline pharmaceutical and methods of preparation and use thereof |
Apr, 2029
(4 years from now) | Active |
| US8592450 | Compositions and methods for treatment of eye disorders |
May, 2026
(1 year, 5 months from now) | Active |
| US9216174 | Modulators of cellular adhesion |
Nov, 2024
(10 days ago) |
Expired
|
| US10124000 | Modulators of cellular adhesion |
Nov, 2024
(10 days ago) |
Expired
|
| US7790743 | Modulators of cellular adhesion |
Nov, 2024
(10 days ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xiidra's patents.
Latest Legal Activities on Xiidra's Patents
Given below is the list of recent legal activities going on the following patents of Xiidra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Withdrawal of Application for PTE Critical | 02 Jul, 2024 | US8084047 |
| Withdrawal of Application for PTE Critical | 02 Jul, 2024 | US8168655 |
| Withdrawal of Application for PTE Critical | 02 Jul, 2024 | US8592450 |
| Notice of Final Determination -Eligible | 02 Jul, 2024 | US7314938 |
| Withdrawal of Application for PTE Critical | 02 Jul, 2024 | US7790743 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Feb, 2024 | US9447077 |
| Paralegal TD Not accepted | 14 Feb, 2024 | US7314938 |
| Email Notification Critical | 17 Jan, 2024 | US7314938 |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Jan, 2024 | US7314938 |
| Email Notification Critical | 05 Jan, 2024 | US8592450 |
FDA has granted several exclusivities to Xiidra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xiidra, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xiidra.
Exclusivity Information
Xiidra holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Xiidra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 11, 2021 |
US patents provide insights into the exclusivity only within the United States, but Xiidra is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xiidra's family patents as well as insights into ongoing legal events on those patents.
Xiidra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xiidra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 18, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xiidra Generic API suppliers:
Lifitegrast is the generic name for the brand Xiidra. 3 different companies have already filed for the generic of Xiidra, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xiidra's generic
How can I launch a generic of Xiidra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xiidra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xiidra's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Xiidra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 | 13 Jul, 2020 | 4 | 04 Aug, 2023 | 25 Jul, 2033 | Eligible |
Alternative Brands for Xiidra
Xiidra which is used for relieving symptoms of dry eye disease., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Xiidra
Xiidra is a drug owned by Bausch And Lomb Inc. It is used for relieving symptoms of dry eye disease. Xiidra uses Lifitegrast as an active ingredient. Xiidra was launched by Bausch And Lomb Inc in 2016.
Can you believe Xiidra received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Xiidra was approved by FDA for market use on 11 July, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xiidra is 11 July, 2016, its NCE-1 date is estimated to be 11 July, 2020.
Active Ingredient:
Xiidra uses Lifitegrast as the active ingredient. Check out other Drugs and Companies using Lifitegrast ingredient
Treatment:
Xiidra is used for relieving symptoms of dry eye disease.
Dosage:
Xiidra is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | SOLUTION/DROPS | Prescription | OPHTHALMIC |