Xtoro is a drug owned by Fonseca Biosciences Llc. It is protected by 6 US drug patents filed from 2015 to 2022. Out of these, 4 drug patents are active and 2 have expired. Xtoro's patents have been open to challenges since 18 June, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 21, 2033. Details of Xtoro'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. | |||
| US6432948 | Use of 7-(2-oxa-5,8-diazabicylco[4.3.0]non-8-yl)-quinolone carboxylic acid and naphthyridon carboxylic acid derivatives for the treatment of heliobacter pylori infections and associated gastroduodenal diseases |
Apr, 2017
(8 years ago) |
Expired
|
| US6133260 | Use of 7-(2-oxa-5,8-diazabicyclo[4.3.0]non-8-yl)-quinolone carboxylic acid and naphthyridon carboxylic acid derivatives for the treatment of Helicobacter pylori infections and associated gastroduodenal diseases |
Apr, 2017
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9504691 | Finafloxacin suspension compositions |
Nov, 2033
(8 years from now) | Active |
| US8536167 | Methods for treating ophthalmic, otic, or nasal infections |
Aug, 2031
(6 years from now) | Active |
| US9993483 | Compositions and methods for treating ophthalmic, octic, or nasal infections |
Jul, 2030
(5 years from now) | Active |
| US9119859 | Methods for treating otic infections |
Jul, 2030
(5 years 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 Xtoro's patents.
Latest Legal Activities on Xtoro's Patents
Given below is the list of recent legal activities going on the following patents of Xtoro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 May, 2024 | US9504691 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Feb, 2023 | US9119859 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 Nov, 2022 | US9993483 |
| Change in Power of Attorney (May Include Associate POA) Critical | 14 Nov, 2022 | US9119859 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Nov, 2022 | US9504691 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Nov, 2022 | US8536167 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Oct, 2022 | US9993483 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Oct, 2022 | US9504691 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Oct, 2022 | US8536167 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Oct, 2022 | US9119859 |
FDA has granted several exclusivities to Xtoro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xtoro, 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 Xtoro.
Exclusivity Information
Xtoro holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Xtoro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 17, 2019 |
| Pediatric Exclusivity(PED) | Jun 17, 2020 |
US patents provide insights into the exclusivity only within the United States, but Xtoro 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 Xtoro's family patents as well as insights into ongoing legal events on those patents.
Xtoro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xtoro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 21, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xtoro Generics:
There are no approved generic versions for Xtoro as of now.
Alternative Brands for Xtoro
Xtoro which is used for treating acute external ear infections., 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Sandoz |
| |||
About Xtoro
Xtoro is a drug owned by Fonseca Biosciences Llc. It is used for treating acute external ear infections. Xtoro uses Finafloxacin as an active ingredient. Xtoro was launched by Fonseca Biosciences in 2014.
Approval Date:
Xtoro was approved by FDA for market use on 17 December, 2014.
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 Xtoro is 17 December, 2014, its NCE-1 date is estimated to be 18 June, 2019.
Active Ingredient:
Xtoro uses Finafloxacin as the active ingredient. Check out other Drugs and Companies using Finafloxacin ingredient
Treatment:
Xtoro is used for treating acute external ear infections.
Dosage:
Xtoro is available in suspension/drops form for otic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3% | SUSPENSION/DROPS | Discontinued | OTIC |