Abstral is a drug owned by Sentynl Therapeutics Inc. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 24, 2019. Details of Abstral'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). | |||
| US7910132 | Pharmaceutical composition for the treatment of acute disorders |
Sep, 2019
(5 years ago) |
Expired
|
| US6761910 | Pharmaceutical composition for the treatment of acute disorders |
Sep, 2019
(5 years ago) |
Expired
|
| US6759059 | Fentanyl composition for the treatment of acute pain |
Sep, 2019
(5 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 Abstral's patents.
Latest Legal Activities on Abstral's Patents
Given below is the list of recent legal activities going on the following patents of Abstral.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 24 Apr, 2023 | US7910132 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 07 Nov, 2022 | US7910132 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Aug, 2018 | US7910132 (Litigated) |
| Post Issue Communication - Certificate of Correction | 10 Feb, 2016 | US7910132 (Litigated) |
| Post Issue Communication - Certificate of Correction | 05 Mar, 2013 | US7910132 (Litigated) |
| Mail Miscellaneous Communication to Applicant | 01 Mar, 2013 | US7910132 (Litigated) |
| Miscellaneous Communication to Applicant - No Action Count | 28 Feb, 2013 | US7910132 (Litigated) |
| Certificate of Correction Memo | 27 Feb, 2013 | US7910132 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Jan, 2013 | US6761910 (Litigated) |
| Correspondence Address Change Critical | 17 Jan, 2013 | US6759059 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Abstral 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 Abstral's family patents as well as insights into ongoing legal events on those patents.
Abstral's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Abstral's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 24, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Abstral Generic API suppliers:
Fentanyl Citrate is the generic name for the brand Abstral. 9 different companies have already filed for the generic of Abstral, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Abstral's generic
How can I launch a generic of Abstral before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Abstral's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Abstral'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 Abstral -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 19 Jun, 2014 | 1 | 17 Nov, 2017 | 24 Sep, 2019 | Deferred |
Alternative Brands for Abstral
Abstral which is used for managing breakthrough pain in cancer patients., 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 | ||
|---|---|---|---|---|
| Adalvo |
| |||
| Btcp Pharma |
| |||
| Cephalon |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fentanyl Citrate, Abstral's active ingredient. Check the complete list of approved generic manufacturers for Abstral
About Abstral
Abstral is a drug owned by Sentynl Therapeutics Inc. It is used for managing breakthrough pain in cancer patients. Abstral uses Fentanyl Citrate as an active ingredient. Abstral was launched by Sentynl Theraps Inc in 2011.
Approval Date:
Abstral was approved by FDA for market use on 07 January, 2011.
Active Ingredient:
Abstral uses Fentanyl Citrate as the active ingredient. Check out other Drugs and Companies using Fentanyl Citrate ingredient
Treatment:
Abstral is used for managing breakthrough pain in cancer patients.
Dosage:
Abstral is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |
| EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |
| EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |
| EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |
| EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |
| EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | SUBLINGUAL |