Pancreaze is a drug owned by Vivus Inc. It is protected by 5 US drug patents filed in 2018 out of which none have expired yet. Pancreaze's patents have been open to challenges since 12 April, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 20, 2028. Details of Pancreaze'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). | |||
| US8562978 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562981 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562980 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562979 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8221747 | Stable pancreatic enzyme compositions |
Feb, 2028
(3 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 Pancreaze's patents.
Latest Legal Activities on Pancreaze's Patents
Given below is the list of recent legal activities going on the following patents of Pancreaze.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jan, 2024 | US8221747 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Apr, 2021 | US8562978 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Apr, 2021 | US8562981 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Apr, 2021 | US8562980 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Apr, 2021 | US8562979 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2020 | US8221747 |
| Email Notification Critical | 29 Sep, 2014 | US8562979 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Sep, 2014 | US8221747 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Sep, 2014 | US8562978 |
| Email Notification Critical | 29 Sep, 2014 | US8221747 |
FDA has granted several exclusivities to Pancreaze. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pancreaze, 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 Pancreaze.
Exclusivity Information
Pancreaze holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Pancreaze's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 12, 2015 |
US patents provide insights into the exclusivity only within the United States, but Pancreaze 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 Pancreaze's family patents as well as insights into ongoing legal events on those patents.
Pancreaze's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pancreaze's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 20, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pancreaze Generics:
There are no approved generic versions for Pancreaze as of now.
Alternative Brands for Pancreaze
Pancreaze which is used for treating exocrine pancreatic insufficiency related to conditions like cystic fibrosis., has several other brand drugs in the same treatment category and 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Aptalis Pharma Us |
| |||
| Zenpep |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Pancrelipase (amylase;lipase;protease). Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
About Pancreaze
Pancreaze is a drug owned by Vivus Inc. It is used for treating exocrine pancreatic insufficiency related to conditions like cystic fibrosis. Pancreaze uses Pancrelipase (Amylase;Lipase;Protease) as an active ingredient. Pancreaze was launched by Vivus Inc in 2014.
Approval Date:
Pancreaze was approved by FDA for market use on 07 March, 2014.
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 Pancreaze is 07 March, 2014, its NCE-1 date is estimated to be 12 April, 2014.
Active Ingredient:
Pancreaze uses Pancrelipase (amylase;lipase;protease) as the active ingredient. Check out other Drugs and Companies using Pancrelipase (amylase;lipase;protease) ingredient
Treatment:
Pancreaze is used for treating exocrine pancreatic insufficiency related to conditions like cystic fibrosis.
Dosage:
Pancreaze is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10,850USP UNITS;2,600USP UNITS;6,200USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |