Zenpep is a drug owned by Aptalis Pharma Us Inc. It is protected by 7 US drug patents filed in 2013 out of which none have expired yet. Zenpep's patents have been open to challenges since 27 August, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 20, 2028. Details of Zenpep'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). | |||
| US8562979 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8246950 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8221747 | Stable pancreatic enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562978 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US7658918 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562980 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562981 | Stable digestive 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 Zenpep's patents.
Latest Legal Activities on Zenpep's Patents
Given below is the list of recent legal activities going on the following patents of Zenpep.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 29 Sep, 2014 | US8246950 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Sep, 2014 | US8246950 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2014 | US7658918 |
| Email Notification Critical | 26 Sep, 2014 | US7658918 |
| Correspondence Address Change Critical | 24 Sep, 2014 | US7658918 |
| Correspondence Address Change Critical | 24 Sep, 2014 | US8246950 |
| Mail Pre-Exam Notice | 05 Aug, 2014 | US7658918 |
FDA has granted several exclusivities to Zenpep. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zenpep, 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 Zenpep.
Exclusivity Information
Zenpep holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Zenpep's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2014 |
US patents provide insights into the exclusivity only within the United States, but Zenpep 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 Zenpep's family patents as well as insights into ongoing legal events on those patents.
Zenpep's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zenpep'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)
Zenpep Generics:
There are no approved generic versions for Zenpep as of now.
Alternative Brands for Zenpep
Zenpep which is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions., 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 | ||
|---|---|---|---|---|
| Vivus Inc |
| |||
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 Zenpep
Zenpep is a drug owned by Aptalis Pharma Us Inc. It is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions. Zenpep uses Pancrelipase (Amylase;Lipase;Protease) as an active ingredient. Zenpep was launched by Aptalis Pharma Us in 2014.
Approval Date:
Zenpep was approved by FDA for market use on 25 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 Zenpep is 25 March, 2014, its NCE-1 date is estimated to be 27 August, 2013.
Active Ingredient:
Zenpep uses Pancrelipase (amylase;lipase;protease) as the active ingredient. Check out other Drugs and Companies using Pancrelipase (amylase;lipase;protease) ingredient
Treatment:
Zenpep is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions.
Dosage:
Zenpep is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 109,000USP UNITS;20,000USP UNITS;68,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 55,000USP UNITS;10,000USP UNITS;34,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 27,000USP UNITS;5,000USP UNITS;17,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 82,000USP UNITS;15,000USP UNITS;51,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 136,000USP UNITS;25,000USP UNITS;85,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| 16,000USP UNITS;3,000USP UNITS;10,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
Zenpep is a drug owned by Zenpep Llc. It is protected by 5 US drug patents filed in 2014 out of which none have expired yet. Zenpep's patents have been open to challenges since 27 August, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 20, 2028. Details of Zenpep'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 |
| US8562980 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562981 | Stable digestive enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8221747 | Stable pancreatic enzyme compositions |
Feb, 2028
(3 years from now) | Active |
| US8562979 | Stable digestive 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 Zenpep's patents.
Latest Legal Activities on Zenpep's Patents
Given below is the list of recent legal activities going on the following patents of Zenpep.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| 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 Critical | 29 Sep, 2014 | US8246950 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 Sep, 2014 | US8246950 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2014 | US7658918 |
| Email Notification Critical | 26 Sep, 2014 | US7658918 |
| Correspondence Address Change Critical | 24 Sep, 2014 | US7658918 |
| Correspondence Address Change Critical | 24 Sep, 2014 | US8246950 |
| Mail Pre-Exam Notice | 05 Aug, 2014 | US7658918 |
FDA has granted several exclusivities to Zenpep. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zenpep, 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 Zenpep.
Exclusivity Information
Zenpep holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Zenpep's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2014 |
US patents provide insights into the exclusivity only within the United States, but Zenpep 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 Zenpep's family patents as well as insights into ongoing legal events on those patents.
Zenpep's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zenpep'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)
Zenpep Generics:
There are no approved generic versions for Zenpep as of now.
Alternative Brands for Zenpep
Zenpep which is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions., 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 | ||
|---|---|---|---|---|
| Vivus Inc |
| |||
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 Zenpep
Zenpep is a drug owned by Zenpep Llc. It is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions. Zenpep uses Pancrelipase (Amylase;Lipase;Protease) as an active ingredient. Zenpep was launched by Zenpep in 2014.
Approval Date:
Zenpep was approved by FDA for market use on 25 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 Zenpep is 25 March, 2014, its NCE-1 date is estimated to be 27 August, 2013.
Active Ingredient:
Zenpep uses Pancrelipase (amylase;lipase;protease) as the active ingredient. Check out other Drugs and Companies using Pancrelipase (amylase;lipase;protease) ingredient
Treatment:
Zenpep is used for managing symptoms of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions.
Dosage:
Zenpep is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 168,000USP UNITS;40,000USP UNITS;126,000USP UNITS | CAPSULE, DELAYED RELEASE | Prescription | ORAL |