Acthar Gel is a drug owned by Mallinckrodt Ard Inc. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 25, 2041. Details of Acthar Gel'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). | |||
| US11752199 | Methods of modulating pericytes |
Feb, 2041
(16 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 Acthar Gel's patents.
Latest Legal Activities on Acthar Gel's Patents
Given below is the list of recent legal activities going on the following patents of Acthar Gel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752199 |
| Sequence Moved to Public Database | 12 Sep, 2023 | US11752199 |
| Email Notification Critical | 12 Sep, 2023 | US11752199 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752199 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752199 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Sep, 2023 | US11752199 |
| Recordation of Patent Grant Mailed Critical | 12 Sep, 2023 | US11752199 |
| Email Notification Critical | 24 Aug, 2023 | US11752199 |
| Issue Notification Mailed Critical | 23 Aug, 2023 | US11752199 |
| Application Is Considered Ready for Issue Critical | 02 Aug, 2023 | US11752199 |
FDA has granted several exclusivities to Acthar Gel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Acthar Gel, 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 Acthar Gel.
Exclusivity Information
Acthar Gel holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Acthar Gel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Oct 15, 2017 |
US patents provide insights into the exclusivity only within the United States, but Acthar Gel 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 Acthar Gel's family patents as well as insights into ongoing legal events on those patents.
Acthar Gel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Acthar Gel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 25, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acthar Gel Generic API suppliers:
Corticotropin is the generic name for the brand Acthar Gel. 1 company has already filed for the generic of Acthar Gel. Check out the entire list of companies who have already received approval for Acthar Gel's generic
Alternative Brands for Acthar Gel
Acthar Gel which is used for promoting new vessel formation in ophthalmic diseases., has several other brand drugs using the same active ingredient (Corticotropin). 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 | |
|---|---|---|
| Ani Pharms |
| |
| Mallinckrodt Ard |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Corticotropin, Acthar Gel's active ingredient. Check the complete list of approved generic manufacturers for Acthar Gel
About Acthar Gel
Acthar Gel is a drug owned by Mallinckrodt Ard Inc. It is used for promoting new vessel formation in ophthalmic diseases. Acthar Gel uses Corticotropin as an active ingredient. Acthar Gel was launched by Mallinckrodt Ard in 1982.
Approval Date:
Acthar Gel was approved by FDA for market use on 01 January, 1982.
Active Ingredient:
Acthar Gel uses Corticotropin as the active ingredient. Check out other Drugs and Companies using Corticotropin ingredient
Treatment:
Acthar Gel is used for promoting new vessel formation in ophthalmic diseases.
Dosage:
Acthar Gel is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 80 UNITS/ML | INJECTABLE | Prescription | INJECTION |