Onsolis is a drug owned by Adalvo Ltd. It is protected by 4 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 23, 2027. Details of Onsolis'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). | |||
| US9597288 | Transmucosal delivery devices with enhanced uptake |
Jul, 2027
(2 years from now) | Active |
| US9579288 | Tesofensine and beta blocker combination formulations |
Jul, 2027
(2 years from now) | Active |
| US7579019 | Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces |
Jan, 2020
(5 years ago) |
Expired
|
| US6159498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces |
Oct, 2016
(8 years 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 Onsolis's patents.
Latest Legal Activities on Onsolis's Patents
Given below is the list of recent legal activities going on the following patents of Onsolis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 27 Sep, 2021 | US7579019 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 12 Apr, 2021 | US7579019 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Sep, 2020 | US9597288 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 14 Aug, 2020 | US9579288 |
| Review Certificate Mailed | 08 Feb, 2018 | US7579019 (Litigated) |
| Review Certificate | 15 Dec, 2017 | US7579019 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 21 Mar, 2017 | US9597288 |
| Recordation of Patent Grant Mailed Critical | 21 Mar, 2017 | US9597288 |
| Email Notification Critical | 02 Mar, 2017 | US9597288 |
| Issue Notification Mailed Critical | 01 Mar, 2017 | US9597288 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Onsolis and ongoing litigations to help you estimate the early arrival of Onsolis generic.
Onsolis's Litigations
Onsolis been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 22, 2014, against patent number US7579019. The petitioner MONOSOL RX, LLC, challenged the validity of this patent, with Arius Two, Inc. as the respondent. Click below to track the latest information on how companies are challenging Onsolis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7579019 | January, 2014 |
FWD Entered
(05 Aug, 2015) | Arius Two, Inc. | MONOSOL RX, LLC |
FDA has granted some exclusivities to Onsolis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onsolis, 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 Onsolis.
Exclusivity Information
Onsolis holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Onsolis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 16, 2012 |
US patents provide insights into the exclusivity only within the United States, but Onsolis 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 Onsolis's family patents as well as insights into ongoing legal events on those patents.
Onsolis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Onsolis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 23, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Onsolis Generic API suppliers:
Fentanyl Citrate is the generic name for the brand Onsolis. 9 different companies have already filed for the generic of Onsolis, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onsolis's generic
Alternative Brands for Onsolis
Onsolis which is used for managing breakthrough pain in patients with cancer., has several other brand drugs in the same treatment category and using the same active ingredient (Fentanyl Citrate). 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 | ||
|---|---|---|---|---|
| Btcp Pharma |
| |||
| Cephalon |
| |||
| Sentynl Theraps Inc |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fentanyl Citrate, Onsolis's active ingredient. Check the complete list of approved generic manufacturers for Onsolis
About Onsolis
Onsolis is a drug owned by Adalvo Ltd. It is used for managing breakthrough pain in patients with cancer. Onsolis uses Fentanyl Citrate as an active ingredient. Onsolis was launched by Adalvo in 2009.
Approval Date:
Onsolis was approved by FDA for market use on 16 July, 2009.
Active Ingredient:
Onsolis uses Fentanyl Citrate as the active ingredient. Check out other Drugs and Companies using Fentanyl Citrate ingredient
Treatment:
Onsolis is used for managing breakthrough pain in patients with cancer.
Dosage:
Onsolis is available in film form for buccal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.2MG BASE | FILM | Discontinued | BUCCAL |
| EQ 0.4MG BASE | FILM | Discontinued | BUCCAL |
| EQ 0.6MG BASE | FILM | Discontinued | BUCCAL |
| EQ 0.8MG BASE | FILM | Discontinued | BUCCAL |
| EQ 1.2MG BASE | FILM | Discontinued | BUCCAL |