Pancrelipase (amylase;lipase;protease) Patent Expiration

Pancrelipase (Amylase;Lipase;Protease) is Used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions. It was first introduced by Organon Usa Inc in its drug Cotazym on Dec 9, 1996. Other drugs containing Pancrelipase (Amylase;Lipase;Protease) are Ultresa, Zenpep, Viokace, Creon, Pancreaze, Pertzye. 7 different companies have introduced drugs containing Pancrelipase (Amylase;Lipase;Protease).


Pancrelipase (amylase;lipase;protease) Patents

Given below is the list of patents protecting Pancrelipase (amylase;lipase;protease), along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Creon US9198871 Delayed release pancreatin compositions Feb 07, 2030 Abbvie
Pancreaze US8221747 Stable pancreatic enzyme compositions Feb 20, 2028 Vivus Inc
Pancreaze US8562978 Stable digestive enzyme compositions Feb 20, 2028 Vivus Inc
Pancreaze US8562979 Stable digestive enzyme compositions Feb 20, 2028 Vivus Inc
Pancreaze US8562980 Stable digestive enzyme compositions Feb 20, 2028 Vivus Inc
Pancreaze US8562981 Stable digestive enzyme compositions Feb 20, 2028 Vivus Inc
Zenpep US7658918 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8221747 Stable pancreatic enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8221747 Stable pancreatic enzyme compositions Feb 20, 2028 Zenpep
Zenpep US8246950 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8562978 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8562978 Stable digestive enzyme compositions Feb 20, 2028 Zenpep
Zenpep US8562979 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8562979 Stable digestive enzyme compositions Feb 20, 2028 Zenpep
Zenpep US8562980 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8562980 Stable digestive enzyme compositions Feb 20, 2028 Zenpep
Zenpep US8562981 Stable digestive enzyme compositions Feb 20, 2028 Aptalis Pharma Us
Zenpep US8562981 Stable digestive enzyme compositions Feb 20, 2028 Zenpep



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 Pancrelipase (amylase;lipase;protease)'s patents.

Given below is the list recent legal activities going on the following patents of Pancrelipase (amylase;lipase;protease).

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 07 Feb, 2024 US8246950
Payment of Maintenance Fee, 12th Year, Large Entity 28 Jul, 2021 US7658918
Payment of Maintenance Fee, 8th Year, Large Entity 21 Feb, 2020 US8246950
Email Notification 29 Sep, 2014 US8246950
Change in Power of Attorney (May Include Associate POA) 29 Sep, 2014 US8246950
Change in Power of Attorney (May Include Associate POA) 26 Sep, 2014 US7658918
Email Notification 26 Sep, 2014 US7658918
Correspondence Address Change 24 Sep, 2014 US7658918
Correspondence Address Change 24 Sep, 2014 US8246950
Mail Pre-Exam Notice 05 Aug, 2014 US7658918


Pancrelipase (amylase;lipase;protease)'s Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pancrelipase (amylase;lipase;protease):

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. Pancrelipase (amylase;lipase;protease) has 1 clinical trial that has been verified in 2024.

Title Lead Sponsor Collaborators Status Phases
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) Memorial Sloan Kettering Cancer Center RECRUITING
(Jul, 2024)
PHASE1, PHASE2
CREON for the Treatment of Post-RYGB Hypoglycemia East Carolina University TERMINATED
(Oct, 2023)
PHASE1
A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition Shenzhen Kangzhe Pharmaceutical Co., Ltd. UNKNOWN
(Aug, 2019)
NA
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI) Forest Laboratories COMPLETED
(Feb, 2017)
PHASE3
Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer Baylor Research Institute UNKNOWN
(Jan, 2017)
NA
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Abbott COMPLETED
(Jan, 2016)
PHASE3
Creon in HIV Patients With Steatorrhea Abbott TERMINATED
(Jul, 2011)
PHASE3
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. COMPLETED
(Apr, 2010)
PHASE2
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) Solvay Pharmaceuticals COMPLETED
(Feb, 2010)
PHASE3
Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis National Center for Research Resources (NCRR) Indiana University School of Medicine COMPLETED
(Jul, 2000)
NA