Omontys Patent Expiration

Omontys 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'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'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

(4 months ago)

Expired
US7919118 Spacer moiety for poly (ethylene glycol) modified peptide based compounds
May, 2024

(4 months ago)

Expired
US7084245 Peptides that bind to the erythropoietin receptor
May, 2024

(4 months ago)

Expired
US7414105 Peptides that bind to the erythropoietin receptor
May, 2024

(4 months ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7550433 Erythropoietin receptor peptide formulations and uses
Jun, 2026

(1 year, 7 months from now)

Active
US7919461 Erythropoietin receptor peptide formulations and uses
Jun, 2026

(1 year, 7 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's patents.

Given below is the list of recent legal activities going on the following patents of Omontys.

Activity Date Patent Number
Patent litigations
Expire Patent 26 Jul, 2021 US7550433
Expire Patent 07 Jun, 2021 US7528104
Maintenance Fee Reminder Mailed 08 Feb, 2021 US7550433
Maintenance Fee Reminder Mailed 21 Dec, 2020 US7528104
Expire Patent 21 Sep, 2020 US7414105
Maintenance Fee Reminder Mailed 06 Apr, 2020 US7414105
Expire Patent 13 May, 2019 US7919118
Expire Patent 13 May, 2019 US7919461
Maintenance Fee Reminder Mailed 26 Nov, 2018 US7919118
Maintenance Fee Reminder Mailed 26 Nov, 2018 US7919461

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US patents provide insights into the exclusivity only within the United States, but Omontys 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's family patents as well as insights into ongoing legal events on those patents.

Omontys's Family Patents

Omontys has patent protection in a total of 34 countries. It's US patent count contributes only to 25.8% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Omontys.

Family Patents

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Generic Launch

Generic Release Date:

Omontys's generic launch date based on the expiry of its last outstanding patent 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 Generics:

There are no approved generic versions for Omontys as of now.

Alternative Brands for Omontys

Omontys which is used for managing anemia associated with 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.

Drug Owner Drug Name Treatment Area
Glaxosmithkline
Jesduvroq Used for managing anemia associated with chronic kidney disease.
Takeda Pharms Usa
Omontys Preservative Free

(uses Peginesatide Acetate)

Used for treating anemia caused by chronic kidney disease.





About Omontys

Omontys is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing anemia associated with chronic kidney disease. Omontys uses Peginesatide Acetate as an active ingredient. Omontys was launched by Takeda Pharms Usa in 2012.

Can you believe Omontys 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 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 is 27 March, 2012, its NCE-1 date is estimated to be 27 March, 2016.

Active Ingredient:

Omontys uses Peginesatide Acetate as the active ingredient. Check out other Drugs and Companies using Peginesatide Acetate ingredient

Treatment:

Omontys is used for managing anemia associated with chronic kidney disease.

Dosage:

Omontys is available in solution form for intravenous, subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 10MG BASE/ML (EQ 10MG BASE/ML) SOLUTION Discontinued INTRAVENOUS, SUBCUTANEOUS
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) SOLUTION Discontinued INTRAVENOUS, SUBCUTANEOUS