OMONTYS Drug Patent Profile
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When do Omontys patents expire, and when can generic versions of Omontys launch?
Omontys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and fourteen patent family members in thirty-four countries.
The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.
DrugPatentWatch® Generic Entry Outlook for Omontys
Omontys was eligible for patent challenges on March 27, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 12, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for OMONTYS
| International Patents: | 114 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 18 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | OMONTYS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMONTYS
Generic Entry Date for OMONTYS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for OMONTYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amgen | Phase 4 |
| Takeda | Phase 3 |
| Affymax | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for OMONTYS
US Patents and Regulatory Information for OMONTYS
OMONTYS is protected by six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OMONTYS is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting OMONTYS
Peptides that bind to the erythropoietin receptor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Peptides that bind to the erythropoietin receptor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Peptides that bind to the erythropoietin receptor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Erythropoietin receptor peptide formulations and uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
Spacer moiety for poly (ethylene glycol) modified peptide based compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Erythropoietin receptor peptide formulations and uses
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | OMONTYS PRESERVATIVE FREE | peginesatide acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799-005 | Mar 27, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Takeda Pharms Usa | OMONTYS PRESERVATIVE FREE | peginesatide acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799-004 | Mar 27, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Takeda Pharms Usa | OMONTYS PRESERVATIVE FREE | peginesatide acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799-006 | Mar 27, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Takeda Pharms Usa | OMONTYS PRESERVATIVE FREE | peginesatide acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799-003 | Mar 27, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OMONTYS
See the table below for patents covering OMONTYS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2004101606 | ⤷ Try a Trial | |
| Israel | 171782 | PEPTIDE DIMERS WHICH COMPRISE POLYETHYLENE GLYCOL THAT BIND TO THE ERYTHROPOIETIN RECEPTOR, PHARMACEUTICAL COMPOSITIONS THEREOF AND USE THEREOF | ⤷ Try a Trial |
| Mexico | PA05012314 | RADICAL SEPARADOR PARA PEPTIDO MODIFICADO CON POLIETILENGLICOL. (SPACER MOIETY FOR POLY(ETHYLENE GLYCOL) -MODIFIED PEPTIDES.) | ⤷ Try a Trial |
| Germany | 602004020610 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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