Aemcolo is a drug owned by Redhill Biopharma Inc. It is protected by 4 US drug patents filed in 2018 out of which none have expired yet. Aemcolo's patents will be open to challenges from 17 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 16, 2028. Details of Aemcolo'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). | |||
| US8741948 | Oral antimicrobial pharmaceutical compositions |
May, 2025
(4 months from now) | Active |
| US8529945 | Oral antimicrobial pharmaceutical compositions |
May, 2025
(4 months from now) | Active |
| US8263120 | Oral antimicrobial pharmaceutical compositions |
May, 2025
(4 months from now) | Active |
| US8486446 | Oral antimicrobial pharmaceutical compositions |
May, 2025
(4 months 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 Aemcolo's patents.
Latest Legal Activities on Aemcolo's Patents
Given below is the list of recent legal activities going on the following patents of Aemcolo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Feb, 2024 | US8263120 |
| Withdrawal of Application for PTE Critical | 30 Nov, 2023 | US8263120 |
| Withdrawal of Application for PTE Critical | 30 Nov, 2023 | US8741948 |
| Withdrawal of Application for PTE Critical | 30 Nov, 2023 | US8529945 |
| Withdrawal of Application for PTE Critical | 30 Nov, 2023 | US8486446 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Nov, 2021 | US8741948 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2021 | US8529945 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Jan, 2021 | US8486446 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Mar, 2020 | US8263120 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 Dec, 2019 | US8486446 |
FDA has granted several exclusivities to Aemcolo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aemcolo, 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 Aemcolo.
Exclusivity Information
Aemcolo holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Aemcolo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 16, 2023 |
| Generating Antibiotic Incentives Now(GAIN) | Nov 16, 2028 |
US patents provide insights into the exclusivity only within the United States, but Aemcolo 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 Aemcolo's family patents as well as insights into ongoing legal events on those patents.
Aemcolo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aemcolo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 16, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aemcolo Generics:
There are no approved generic versions for Aemcolo as of now.
About Aemcolo
Aemcolo is a drug owned by Redhill Biopharma Inc. It is used for treating travelers' diarrhea caused by non-invasive strains of Escherichia coli in adults. Aemcolo uses Rifamycin Sodium as an active ingredient. Aemcolo was launched by Redhill in 2018.
Approval Date:
Aemcolo was approved by FDA for market use on 16 November, 2018.
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 Aemcolo is 16 November, 2018, its NCE-1 date is estimated to be 17 November, 2027.
Active Ingredient:
Aemcolo uses Rifamycin Sodium as the active ingredient. Check out other Drugs and Companies using Rifamycin Sodium ingredient
Treatment:
Aemcolo is used for treating travelers' diarrhea caused by non-invasive strains of Escherichia coli in adults.
Dosage:
Aemcolo is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 194MG BASE | TABLET, DELAYED RELEASE | Discontinued | ORAL |