Lokelma is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 15 US drug patents filed from 2018 to 2023. Out of these, 14 drug patents are active and 1 has expired. Lokelma's patents have been open to challenges since 18 May, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 14, 2035. Details of Lokelma'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. | |||
| US9592253 | Extended use zirconium silicate compositions and methods of use thereof |
Oct, 2035
(10 years from now) | Active |
| US10300087 | Extended use zirconium silicate compositions and methods of use thereof |
Oct, 2035
(10 years from now) | Active |
| US9913860 | Microporous zirconium silicate for the treatment of hyperkalemia |
Oct, 2033
(8 years from now) | Active |
| US10695365 | Microporous zirconium silicate for the treatment of hyperkalemia |
Oct, 2033
(8 years from now) | Active |
| US8877255 | Microporous zirconium silicate for the treatment of hyperkalemia |
Oct, 2033
(8 years from now) | Active |
| US8802152 | Microporous zirconium silicate for the treatment of hyperkalemia |
Apr, 2032
(7 years from now) | Active |
| US10413569 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US11406662 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 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). | |||
| US11738044 | Extended use zirconium silicate compositions and methods of use thereof |
Oct, 2035
(10 years from now) | Active |
| US8808750 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US9861658 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US10398730 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US10335432 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US9844567 | Microporous zirconium silicate for the treatment of hyperkalemia |
Feb, 2032
(7 years from now) | Active |
| US6332985 | Process for removing toxins from bodily fluids using zirconium or titanium microporous compositions |
Mar, 2019
(5 years ago) |
Expired
|
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 Lokelma's patents.
Latest Legal Activities on Lokelma's Patents
Given below is the list of recent legal activities going on the following patents of Lokelma.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 06 May, 2024 | US8808750 |
| Withdrawal of Application for PTE Critical | 06 May, 2024 | US8802152 |
| Notice of Final Determination -Election Required | 07 Mar, 2024 | US8808750 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 07 Mar, 2024 | US8802152 |
| Notice of Final Determination -Election Required | 07 Mar, 2024 | US8802152 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 07 Mar, 2024 | US8808750 |
| Requirement for information sent under 37 CFR 1.750 | 16 Feb, 2024 | US8808750 |
| Requirement for information sent under 37 CFR 1.750 | 16 Feb, 2024 | US8802152 |
| FDA Final Eligibility Letter Critical | 30 Jan, 2024 | US8808750 |
| FDA Final Eligibility Letter Critical | 30 Jan, 2024 | US8802152 |
FDA has granted several exclusivities to Lokelma. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lokelma, 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 Lokelma.
Exclusivity Information
Lokelma holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Lokelma's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-261) | Apr 24, 2023 |
| New Chemical Entity Exclusivity(NCE) | May 18, 2023 |
Several oppositions have been filed on Lokelma'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 Lokelma's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lokelma patents.
Lokelma's Oppositions Filed in EPO
Lokelma has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 05, 2019, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP12744254A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12744254A | Aug, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP12744254A | Aug, 2019 | Sandoz AG | Granted and Under Opposition |
| EP12744254A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Lokelma 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 Lokelma's family patents as well as insights into ongoing legal events on those patents.
Lokelma's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Lokelma:
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. Lokelma(Sodium Zirconium Cyclosilicate) has 5 clinical trials that have been verified in 2024. Out of these 5, 2 trial is in PHASE4.
Generic Launch
Generic Release Date:
Lokelma's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 14, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lokelma Generics:
There are no approved generic versions for Lokelma as of now.
How can I launch a generic of Lokelma before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lokelma's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lokelma's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Lokelma -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 g/packet and 10 g/packet | 18 May, 2022 | 5 | 14 Oct, 2035 |
About Lokelma
Lokelma is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating hyperkalemia in adults. Lokelma uses Sodium Zirconium Cyclosilicate as an active ingredient. Lokelma was launched by Astrazeneca in 2018.
Approval Date:
Lokelma was approved by FDA for market use on 18 May, 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 Lokelma is 18 May, 2018, its NCE-1 date is estimated to be 18 May, 2022.
Active Ingredient:
Lokelma uses Sodium Zirconium Cyclosilicate as the active ingredient. Check out other Drugs and Companies using Sodium Zirconium Cyclosilicate ingredient
Treatment:
Lokelma is used for treating hyperkalemia in adults.
Dosage:
Lokelma is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 10GM/PACKET | FOR SUSPENSION | Prescription | ORAL |