Creon is a drug owned by Abbvie Inc. It is protected by 1 US drug patent filed in 2015 out of which none have expired yet. Creon's patents have been open to challenges since 30 April, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 07, 2030. Details of Creon'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). | |||
| US9198871 | Delayed release pancreatin compositions |
Feb, 2030
(5 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 Creon's patents.
Latest Legal Activities on Creon's Patents
Given below is the list of recent legal activities going on the following patents of Creon.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2023 | US9198871 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 May, 2019 | US9198871 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Dec, 2015 | US9198871 |
| Recordation of Patent Grant Mailed Critical | 01 Dec, 2015 | US9198871 |
| Email Notification Critical | 12 Nov, 2015 | US9198871 |
| Issue Notification Mailed Critical | 11 Nov, 2015 | US9198871 |
| Application Is Considered Ready for Issue Critical | 02 Nov, 2015 | US9198871 |
| Dispatch to FDC | 02 Nov, 2015 | US9198871 |
| Printer Rush- No mailing | 30 Oct, 2015 | US9198871 |
| Mailing Corrected Notice of Allowability | 30 Oct, 2015 | US9198871 |
FDA has granted several exclusivities to Creon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Creon, 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 Creon.
Exclusivity Information
Creon holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Creon's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-625) | Apr 30, 2013 |
| M(M-93) | Jul 29, 2019 |
| New Chemical Entity Exclusivity(NCE) | Apr 30, 2014 |
US patents provide insights into the exclusivity only within the United States, but Creon 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 Creon's family patents as well as insights into ongoing legal events on those patents.
Creon's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Creon:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Creon(Pancrelipase (amylase;lipase;protease)) has 1 clinical trial that has been verified in 2024.
Generic Launch
Generic Release Date:
Creon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 07, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Creon Generics:
There are no approved generic versions for Creon as of now.
Alternative Brands for Creon
Creon which is used for treating exocrine pancreatic insufficiency., has several other brand drugs using the same active ingredient (Pancrelipase (amylase;lipase;protease)). 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.
About Creon
Creon is a drug owned by Abbvie Inc. It is used for treating exocrine pancreatic insufficiency. Creon uses Pancrelipase (Amylase;Lipase;Protease) as an active ingredient. Creon was launched by Abbvie in 2009.
Approval Date:
Creon was approved by FDA for market use on 30 April, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Creon is 30 April, 2009, its NCE-1 date is estimated to be 30 April, 2013.
Active Ingredient:
Creon uses Pancrelipase (amylase;lipase;protease) as the active ingredient. Check out other Drugs and Companies using Pancrelipase (amylase;lipase;protease) ingredient
Treatment:
Creon is used for treating exocrine pancreatic insufficiency.
Dosage:
Creon is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |