Elcys is a drug owned by Exela Pharma Sciences Llc. It is protected by 16 US drug patents filed from 2019 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 15, 2039. Details of Elcys'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). | |||
| US11510942 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11969439 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10478453 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10583155 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10653719 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10918662 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10905713 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10905714 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11684636 | Stable, highly pure l-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10933089 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11826383 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11679125 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11648262 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US10912795 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11642370 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 years from now) | Active |
| US11510941 | Stable, highly pure L-cysteine compositions for injection and methods of use |
Jan, 2039
(14 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 Elcys's patents.
Latest Legal Activities on Elcys's Patents
Given below is the list of recent legal activities going on the following patents of Elcys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Petition Requesting Trial | 13 Feb, 2024 | US11642370 |
| Email Notification Critical | 29 Nov, 2023 | US11826383 |
| Recordation of Patent eGrant | 28 Nov, 2023 | US11826383 |
| Application ready for PDX access by participating foreign offices Critical | 28 Nov, 2023 | US11826383 |
| Patent eGrant Notification | 28 Nov, 2023 | US11826383 |
| Mail Patent eGrant Notification | 28 Nov, 2023 | US11826383 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Nov, 2023 | US11826383 |
| Recordation of Patent Grant Mailed Critical | 28 Nov, 2023 | US11826383 |
| Email Notification Critical | 09 Nov, 2023 | US11826383 |
| Issue Notification Mailed Critical | 08 Nov, 2023 | US11826383 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Elcys and ongoing litigations to help you estimate the early arrival of Elcys generic.
Elcys's Litigations
Elcys been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 19, 2020, against patent number US10478453. The petitioner Eton Pharmaceuticals, Inc., challenged the validity of this patent, with Exela Pharma Sciences, LLC as the respondent. Click below to track the latest information on how companies are challenging Elcys's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11642370 | February, 2024 |
Institution Denied
(08 Aug, 2024) | Exela Pharma Sciences, LLC | Nexus Pharmaceuticals LLC |
| US10653719 | September, 2020 |
Institution Denied
(23 Apr, 2021) | Exela Pharma Sciences LLC | Eton Pharmaceuticals, Inc. |
| US10583155 | June, 2020 |
Terminated-Denied
(15 Dec, 2020) | Exela Pharma Sciences, LLC | Eton Pharmaceuticals Inc. |
| US10478453 | May, 2020 |
Institution Denied
(18 Nov, 2020) | Exela Pharma Sciences, LLC | Eton Pharmaceuticals, Inc. |
US patents provide insights into the exclusivity only within the United States, but Elcys 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 Elcys's family patents as well as insights into ongoing legal events on those patents.
Elcys's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Elcys's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 15, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Elcys Generic API suppliers:
Cysteine Hydrochloride is the generic name for the brand Elcys. 2 different companies have already filed for the generic of Elcys, with Dr Reddys Labs Sa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Elcys's generic
How can I launch a generic of Elcys before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Elcys's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Elcys'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 Elcys -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/10 mL | 10 Dec, 2019 | 1 | 08 Apr, 2022 | 15 Jan, 2039 | Eligible |
Alternative Brands for Elcys
Elcys which is used for parenteral nutrition support in patients., has several other brand drugs in the same treatment category and using the same active ingredient (Cysteine Hydrochloride). 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 | ||
|---|---|---|---|---|
| Baxter Hlthcare Corp |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Cysteine Hydrochloride, Elcys's active ingredient. Check the complete list of approved generic manufacturers for Elcys
About Elcys
Elcys is a drug owned by Exela Pharma Sciences Llc. It is used for parenteral nutrition support in patients. Elcys uses Cysteine Hydrochloride as an active ingredient. Elcys was launched by Exela Pharma in 2019.
Approval Date:
Elcys was approved by FDA for market use on 16 April, 2019.
Active Ingredient:
Elcys uses Cysteine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cysteine Hydrochloride ingredient
Treatment:
Elcys is used for parenteral nutrition support in patients.
Dosage:
Elcys is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/10ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |