Purified Cortrophin Gel Patent Expiration

Purified Cortrophin Gel is a drug owned by Ani Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 27, 2043. Details of Purified Cortrophin Gel's patents and their expiration are given in the table below.

Patent strength
7
/ 10

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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).
US12102662 Methods for storing and warming purified corticotropin compositions
Oct, 2043

(17 years from now)

Active
US12440542 NA
Oct, 2043

(17 years from now)

Active
US12233105 Methods for storing and warming purified corticotropin compositions
Oct, 2043

(17 years from now)

Active
US11975047 Methods for storing and warming purified corticotropin compositions
Oct, 2043

(17 years from now)

Active
US12324787 Contactless optical process for identifying objects
Oct, 2043

(17 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 Purified Cortrophin Gel's patents.

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

Activity Date Patent Number
Patent litigations
Information Disclosure Statement considered 04 Sep, 2025 US12440542
track 1 ON 28 Aug, 2025 US12440542
Date Forwarded to Examiner 28 Aug, 2025 US12440542
Terminal Disclaimer Filed 18 Aug, 2025 US12440542
Response after Non-Final Action 18 Aug, 2025 US12440542
PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED 18 Aug, 2025 US12440542
Mail Non-Final Rejection 16 Jul, 2025 US12440542
Electronic Review 16 Jul, 2025 US12440542
Email Notification 16 Jul, 2025 US12440542
Non-Final Rejection 12 Jul, 2025 US12440542

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US patents provide insights into the exclusivity only within the United States, but Purified Cortrophin 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 Purified Cortrophin Gel's family patents as well as insights into ongoing legal events on those patents.

Purified Cortrophin Gel's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Purified Cortrophin Gel's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 27, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Purified Cortrophin Gel Generic API suppliers:

Corticotropin is the generic name for the brand Purified Cortrophin Gel. 1 company has already filed for the generic of Purified Cortrophin Gel. Check out the entire list of companies who have already received approval for Purified Cortrophin Gel's generic

Alternative Brands for Purified Cortrophin Gel

There are several other brand drugs using the same active ingredient (Corticotropin) as Purified Cortrophin Gel. 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
Mallinckrodt Ireland
Acthar Gel
Acthar Gel (autoinjector)


Apart from brand drugs containing the same ingredient, some generics have also been filed for Corticotropin, Purified Cortrophin Gel's active ingredient. Check the complete list of approved generic manufacturers for Purified Cortrophin Gel





About Purified Cortrophin Gel

Purified Cortrophin Gel is a drug owned by Ani Pharmaceuticals Inc. Purified Cortrophin Gel uses Corticotropin as an active ingredient. Purified Cortrophin Gel was launched by Ani Pharma in 1982.

Approval Date:

Purified Cortrophin Gel was approved by FDA for market use on 01 January, 1982.

Active Ingredient:

Purified Cortrophin Gel uses Corticotropin as the active ingredient. Check out other Drugs and Companies using Corticotropin ingredient

Dosage:

Purified Cortrophin 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
40 UNITS/ML INJECTABLE Discontinued INJECTION