Edarbyclor is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2019. Out of these, 4 drug patents are active and 2 have expired. Edarbyclor's patents have been open to challenges since 25 February, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2031. Details of Edarbyclor'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. | |||
| US7157584 | Benzimidazole derivative and use thereof |
May, 2025
(10 days from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9387249 | Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone |
Jul, 2031
(6 years from now) | Active |
| US9169238 | Solid pharmaceutical composition |
Feb, 2030
(4 years from now) | Active |
| US9066936 | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent |
Mar, 2028
(2 years from now) | Active |
| US7572920 | Benzimidazole derivative and use as a II receptor antagonist |
Jan, 2025
(4 months ago) |
Expired
|
| US5583141 | Heterocyclic compounds and their use as angiotensin antagonists |
Dec, 2013
(11 years ago) |
Expired
|
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 Edarbyclor's patents.
Latest Legal Activities on Edarbyclor's Patents
Given below is the list of recent legal activities going on the following patents of Edarbyclor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Dec, 2023 | US9387249 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2023 | US9169238 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9066936 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Sep, 2020 | US7572920 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Dec, 2019 | US9387249 |
| Post Issue Communication - Certificate of Correction | 20 Aug, 2019 | US9387249 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2019 | US9169238 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2018 | US9066936 |
| Email Notification Critical | 27 Jul, 2018 | US9387249 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Jul, 2018 | US9387249 |
FDA has granted several exclusivities to Edarbyclor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Edarbyclor, 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 Edarbyclor.
Exclusivity Information
Edarbyclor holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Edarbyclor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Dec 20, 2014 |
| New Chemical Entity Exclusivity(NCE) | Feb 25, 2016 |
US patents provide insights into the exclusivity only within the United States, but Edarbyclor 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 Edarbyclor's family patents as well as insights into ongoing legal events on those patents.
Edarbyclor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Edarbyclor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Edarbyclor Generic API suppliers:
Azilsartan Kamedoxomil; Chlorthalidone is the generic name for the brand Edarbyclor. 1 company has already filed for the generic of Edarbyclor. Check out the entire list of companies who have already received approval for Edarbyclor's generic
How can I launch a generic of Edarbyclor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Edarbyclor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Edarbyclor'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 Edarbyclor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg/12.5 mg and 40 mg/25 mg | 19 Apr, 2022 | 1 | 01 Jul, 2031 |
Alternative Brands for Edarbyclor
Edarbyclor which is used for managing high blood pressure., has several other brand drugs in the same treatment category . 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott |
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| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
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About Edarbyclor
Edarbyclor is a drug owned by Azurity Pharmaceuticals Inc. It is used for managing high blood pressure. Edarbyclor uses Azilsartan Kamedoxomil; Chlorthalidone as an active ingredient. Edarbyclor was launched by Azurity in 2011.
Approval Date:
Edarbyclor was approved by FDA for market use on 20 December, 2011.
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 Edarbyclor is 20 December, 2011, its NCE-1 date is estimated to be 25 February, 2015.
Active Ingredient:
Edarbyclor uses Azilsartan Kamedoxomil; Chlorthalidone as the active ingredient. Check out other Drugs and Companies using Azilsartan Kamedoxomil; Chlorthalidone ingredient
Treatment:
Edarbyclor is used for managing high blood pressure.
Dosage:
Edarbyclor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG MEDOXOMIL;12.5MG | TABLET | Prescription | ORAL |
| EQ 40MG MEDOXOMIL;25MG | TABLET | Prescription | ORAL |