Accrufer is a drug owned by Shield Tx Uk Ltd. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Accrufer's patents have been open to challenges since 26 July, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 23, 2035. Details of Accrufer's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9802973 | Crystalline forms of ferric maltol |
Oct, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10179120 | Dosage regimen of ferric trimaltol |
Jan, 2035
(9 years from now) | Active |
| US9248148 | Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections |
Mar, 2031
(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 Accrufer's patents.
Latest Legal Activities on Accrufer's Patents
Given below is the list of recent legal activities going on the following patents of Accrufer.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 22 Nov, 2023 | US9802973 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Nov, 2023 | US10179120 |
| Email Notification Critical | 22 Nov, 2023 | US10179120 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Nov, 2023 | US9802973 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 06 Jul, 2022 | US10179120 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 21 Apr, 2021 | US9802973 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 07 Apr, 2021 | US9802973 |
| Initial letter Re: PTE Application to regulating agency | 14 Jan, 2020 | US10179120 |
| Initial letter Re: PTE Application to regulating agency | 14 Jan, 2020 | US9802973 |
| Email Notification Critical | 25 Sep, 2019 | US9802973 |
FDA has granted several exclusivities to Accrufer. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Accrufer, 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 Accrufer.
Exclusivity Information
Accrufer holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Accrufer's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 25, 2024 |
Several oppositions have been filed on Accrufer's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Accrufer's generic, the next section provides detailed information on ongoing and past EP oppositions related to Accrufer patents.
Accrufer's Oppositions Filed in EPO
Accrufer has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 05, 2018, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP15784705A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15784705A | Sep, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Accrufer 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 Accrufer's family patents as well as insights into ongoing legal events on those patents.
Accrufer's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Accrufer's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 23, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Accrufer Generics:
There are no approved generic versions for Accrufer as of now.
About Accrufer
Accrufer is a drug owned by Shield Tx Uk Ltd. It is used for treating iron deficiency. Accrufer uses Ferric Maltol as an active ingredient. Accrufer was launched by Shield Tx in 2019.
Approval Date:
Accrufer was approved by FDA for market use on 25 July, 2019.
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 Accrufer is 25 July, 2019, its NCE-1 date is estimated to be 26 July, 2023.
Active Ingredient:
Accrufer uses Ferric Maltol as the active ingredient. Check out other Drugs and Companies using Ferric Maltol ingredient
Treatment:
Accrufer is used for treating iron deficiency.
Dosage:
Accrufer is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG IRON | CAPSULE | Prescription | ORAL |