Evomela is a drug owned by Acrotech Biopharma Inc. It is protected by 7 US drug patents filed from 2016 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2034. Details of Evomela'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). | |||
| US10040872 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Jan, 2034
(8 years from now) | Active |
| US9493582 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Feb, 2033
(7 years from now) | Active |
| US10940128 | Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same |
Jun, 2030
(5 years from now) | Active |
| US10864183 | Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same |
May, 2030
(5 years from now) | Active |
| US11020363 | Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same |
May, 2030
(5 years from now) | Active |
| US9200088 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US8410077 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(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 Evomela's patents.
Latest Legal Activities on Evomela's Patents
Given below is the list of recent legal activities going on the following patents of Evomela.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jun, 2024 | US10864183 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2024 | US9493582 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 May, 2023 | US9200088 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9493582 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US8410077 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US10040872 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9200088 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jan, 2022 | US10040872 |
| Email Notification Critical | 20 Sep, 2021 | US10940128 |
| Mail O.P. Petition Decision | 20 Sep, 2021 | US10940128 |
FDA has granted several exclusivities to Evomela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Evomela, 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 Evomela.
Exclusivity Information
Evomela holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Evomela's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Mar 10, 2023 |
| Orphan Drug Exclusivity(ODE-110) | Mar 10, 2023 |
US patents provide insights into the exclusivity only within the United States, but Evomela 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 Evomela's family patents as well as insights into ongoing legal events on those patents.
Evomela's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Evomela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Evomela Generic API suppliers:
Melphalan Hydrochloride is the generic name for the brand Evomela. 16 different companies have already filed for the generic of Evomela, with Mylan Institutional having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Evomela's generic
How can I launch a generic of Evomela before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Evomela's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Evomela'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 Evomela -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/vial | 08 Sep, 2017 | 1 | 06 Mar, 2020 | 27 Feb, 2033 | Eligible |
Alternative Brands for Evomela
Evomela which is used for preparing patients with multiple myeloma for stem cell transplantation., has several other brand drugs using the same active ingredient (Melphalan 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Melphalan Hydrochloride, Evomela's active ingredient. Check the complete list of approved generic manufacturers for Evomela
About Evomela
Evomela is a drug owned by Acrotech Biopharma Inc. It is used for preparing patients with multiple myeloma for stem cell transplantation. Evomela uses Melphalan Hydrochloride as an active ingredient. Evomela was launched by Acrotech Biopharma in 2016.
Approval Date:
Evomela was approved by FDA for market use on 10 March, 2016.
Active Ingredient:
Evomela uses Melphalan Hydrochloride as the active ingredient. Check out other Drugs and Companies using Melphalan Hydrochloride ingredient
Treatment:
Evomela is used for preparing patients with multiple myeloma for stem cell transplantation.
Dosage:
Evomela is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |