Omontys Preservative Free is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed in 2013. Out of these, 2 drug patents are active and 4 have expired. Omontys Preservative Free's patents have been open to challenges since 27 March, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2026. Details of Omontys Preservative Free'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. | |||
| US7528104 | Peptides that bind to the erythropoietin receptor |
May, 2024
(6 months ago) |
Expired
|
| US7919118 | Spacer moiety for poly (ethylene glycol) modified peptide based compounds |
May, 2024
(6 months ago) |
Expired
|
| US7414105 | Peptides that bind to the erythropoietin receptor |
May, 2024
(6 months ago) |
Expired
|
| US7084245 | Peptides that bind to the erythropoietin receptor |
May, 2024
(6 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7919461 | Erythropoietin receptor peptide formulations and uses |
Jun, 2026
(1 year, 6 months from now) | Active |
| US7550433 | Erythropoietin receptor peptide formulations and uses |
Jun, 2026
(1 year, 6 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 Omontys Preservative Free's patents.
Latest Legal Activities on Omontys Preservative Free's Patents
Given below is the list of recent legal activities going on the following patents of Omontys Preservative Free.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 26 Jul, 2021 | US7550433 |
| Expire Patent Critical | 07 Jun, 2021 | US7528104 |
| Maintenance Fee Reminder Mailed Critical | 08 Feb, 2021 | US7550433 |
| Maintenance Fee Reminder Mailed Critical | 21 Dec, 2020 | US7528104 |
| Expire Patent Critical | 21 Sep, 2020 | US7414105 |
| Maintenance Fee Reminder Mailed Critical | 06 Apr, 2020 | US7414105 |
| Expire Patent Critical | 13 May, 2019 | US7919118 |
| Expire Patent Critical | 13 May, 2019 | US7919461 |
| Maintenance Fee Reminder Mailed Critical | 26 Nov, 2018 | US7919118 |
| Maintenance Fee Reminder Mailed Critical | 26 Nov, 2018 | US7919461 |
FDA has granted several exclusivities to Omontys Preservative Free. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Omontys Preservative Free, 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 Omontys Preservative Free.
Exclusivity Information
Omontys Preservative Free holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Omontys Preservative Free's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 27, 2017 |
US patents provide insights into the exclusivity only within the United States, but Omontys Preservative Free 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 Omontys Preservative Free's family patents as well as insights into ongoing legal events on those patents.
Omontys Preservative Free's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Omontys Preservative Free's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Omontys Preservative Free Generics:
There are no approved generic versions for Omontys Preservative Free as of now.
Alternative Brands for Omontys Preservative Free
Omontys Preservative Free which is used for treating anemia caused by chronic kidney disease., has several other brand drugs in the same treatment category and using the same active ingredient (Peginesatide Acetate). 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.
About Omontys Preservative Free
Omontys Preservative Free is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating anemia caused by chronic kidney disease. Omontys Preservative Free uses Peginesatide Acetate as an active ingredient. Omontys Preservative Free was launched by Takeda Pharms Usa in 2012.
Can you believe Omontys Preservative Free received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Omontys Preservative Free was approved by FDA for market use on 27 March, 2012.
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 Omontys Preservative Free is 27 March, 2012, its NCE-1 date is estimated to be 27 March, 2016.
Active Ingredient:
Omontys Preservative Free uses Peginesatide Acetate as the active ingredient. Check out other Drugs and Companies using Peginesatide Acetate ingredient
Treatment:
Omontys Preservative Free is used for treating anemia caused by chronic kidney disease.
Dosage:
Omontys Preservative Free is available in solution form for intravenous, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |