Acthar Gel Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Acthar Gel.

Activity Date Patent Number
Patent litigations
Mail Patent eGrant Notification 12 Sep, 2023 US11752199
Sequence Moved to Public Database 12 Sep, 2023 US11752199
Email Notification 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 12 Sep, 2023 US11752199
Recordation of Patent Grant Mailed 12 Sep, 2023 US11752199
Email Notification 24 Aug, 2023 US11752199
Issue Notification Mailed 23 Aug, 2023 US11752199
Application Is Considered Ready for Issue 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

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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


Family Patents

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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 Generics:

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
Purified Cortrophin Gel
Mallinckrodt Ard
Acthar Gel (autoinjector)


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