Xipere is a drug owned by Bausch And Lomb Inc. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 02, 2034. Details of Xipere's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9937075 | Apparatus and methods for ocular injection |
May, 2034
(8 years from now) | Active |
| US9636332 | Methods and devices for the treatment of ocular diseases in human subjects |
Nov, 2033
(8 years from now) | Active |
| US8636713 | Methods and devices for drug delivery to ocular tissue using microneedle |
May, 2027
(1 year, 11 months from now) | Active |
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 Xipere's patents.
Latest Legal Activities on Xipere's Patents
Given below is the list of recent legal activities going on the following patents of Xipere.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination- Ineligible | 31 Oct, 2022 | US9636332 |
| Notice of Final Determination- Ineligible | 31 Oct, 2022 | US8636713 |
| Notice of Final Determination- Ineligible | 31 Oct, 2022 | US9937075 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US8636713 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US9937075 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US9636332 |
| Initial letter Re: PTE Application to regulating agency | 28 Feb, 2022 | US9937075 |
| Initial letter Re: PTE Application to regulating agency | 28 Feb, 2022 | US8636713 |
| Initial letter Re: PTE Application to regulating agency | 28 Feb, 2022 | US9636332 |
| Email Notification Critical | 22 Feb, 2022 | US8636713 |
FDA has granted several exclusivities to Xipere. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xipere, 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 Xipere.
Exclusivity Information
Xipere holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Xipere's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 22, 2024 |
Several oppositions have been filed on Xipere's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xipere's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xipere patents.
Xipere's Oppositions Filed in EPO
Xipere has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 22, 2022, by European Oppositions Limited. This opposition was filed on patent number EP14791646A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14791646A | Mar, 2022 | European Oppositions Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Xipere 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 Xipere's family patents as well as insights into ongoing legal events on those patents.
Xipere's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xipere's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xipere Generic API suppliers:
Triamcinolone Acetonide is the generic name for the brand Xipere. 48 different companies have already filed for the generic of Xipere, with Astellas having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xipere's generic
Alternative Brands for Xipere
Xipere which is used for treating macular edema associated with uveitis., has several other brand drugs using the same active ingredient (Triamcinolone Acetonide). 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Chattem Sanofi |
| |
| Harrow Eye |
| |
| Pacira Pharms Inc |
| |
| Sanofi Aventis Us |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Triamcinolone Acetonide, Xipere's active ingredient. Check the complete list of approved generic manufacturers for Xipere
About Xipere
Xipere is a drug owned by Bausch And Lomb Inc. It is used for treating macular edema associated with uveitis. Xipere uses Triamcinolone Acetonide as an active ingredient. Xipere was launched by Bausch And Lomb Inc in 2021.
Approval Date:
Xipere was approved by FDA for market use on 22 October, 2021.
Active Ingredient:
Xipere uses Triamcinolone Acetonide as the active ingredient. Check out other Drugs and Companies using Triamcinolone Acetonide ingredient
Treatment:
Xipere is used for treating macular edema associated with uveitis.
Dosage:
Xipere is available in suspension form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML | SUSPENSION | Prescription | INJECTION |