Inspra is a drug owned by Upjohn Us 2 Llc. It is protected by 16 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2020. Details of Inspra'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). | |||
|
US6863902 (Pediatric) | Immediate release eplerenone compositions |
Oct, 2020
(5 years ago) |
Expired
|
|
US7157101 (Pediatric) | Micronized eplerenone compositions |
Jun, 2020
(5 years ago) |
Expired
|
|
US6410054 (Pediatric) | Immediate release eplerenone compositions |
Jun, 2020
(5 years ago) |
Expired
|
|
US6558707 (Pediatric) | Immediate release eplerenone compositions |
Jun, 2020
(5 years ago) |
Expired
|
|
US6534093 (Pediatric) | Immediate release eplerenone compositions |
Jun, 2020
(5 years ago) |
Expired
|
|
US6495165 (Pediatric) | Eplerenone compositions having improved bioavailability |
Jun, 2020
(5 years ago) |
Expired
|
|
US6410524 (Pediatric) | Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease |
May, 2020
(5 years ago) |
Expired
|
|
US6747020 (Pediatric) | Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor |
May, 2020
(5 years ago) |
Expired
|
| US6863902 | Immediate release eplerenone compositions |
Apr, 2020
(5 years ago) |
Expired
|
| US6410054 | Immediate release eplerenone compositions |
Dec, 2019
(5 years ago) |
Expired
|
| US6534093 | Immediate release eplerenone compositions |
Dec, 2019
(5 years ago) |
Expired
|
| US7157101 | Micronized eplerenone compositions |
Dec, 2019
(5 years ago) |
Expired
|
| US6495165 | Eplerenone compositions having improved bioavailability |
Dec, 2019
(5 years ago) |
Expired
|
| US6558707 | Immediate release eplerenone compositions |
Dec, 2019
(5 years ago) |
Expired
|
| US6410524 | Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease |
Nov, 2019
(6 years ago) |
Expired
|
| US6747020 | Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor |
Nov, 2019
(6 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 Inspra's patents.
Latest Legal Activities on Inspra's Patents
Given below is the list of recent legal activities going on the following patents of Inspra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jun, 2018 | US7157101 |
| Expire Patent
Critical | 08 Apr, 2013 | US6863902 |
| Patent Issue Date Used in PTA Calculation
Critical | 02 Jan, 2007 | US7157101 |
| Recordation of Patent Grant Mailed
Critical | 02 Jan, 2007 | US7157101 |
| Issue Notification Mailed
Critical | 13 Dec, 2006 | US7157101 |
| Dispatch to FDC | 30 Nov, 2006 | US7157101 |
| Application Is Considered Ready for Issue
Critical | 29 Nov, 2006 | US7157101 |
| Issue Fee Payment Verified
Critical | 22 Nov, 2006 | US7157101 |
| Issue Fee Payment Received
Critical | 22 Nov, 2006 | US7157101 |
| Mail Notice of Allowance
Critical | 23 Aug, 2006 | US7157101 |
FDA has granted several exclusivities to Inspra. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Inspra, 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
Inspra.
Exclusivity Information
Inspra holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Inspra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Pediatric Exclusivity(PED) | Jul 31, 2011 |
US patents provide insights into the exclusivity only within the United States, but
Inspra 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 Inspra's family patents as well as insights into
ongoing legal events
on those patents.
Inspra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Inspra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Inspra Generic API suppliers:
Eplerenone is the generic name for the brand Inspra. 9 different companies have already filed for the generic of Inspra, with Aarxion Anda Hlding having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Inspra's generic
How can I launch a generic of Inspra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Inspra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Inspra'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 Inspra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg and 50 mg | 27 Sep, 2006 | 2 | 30 Jul, 2008 | 10 Apr, 2020 | Eligible |
| 0.75 mg/mL, 100 mL vial | 05 Jun, 2009 | 1 | 05 Jun, 2015 | 15 Sep, 2015 | Eligible |
Alternative Brands for Inspra
Inspra which is used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor., 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 |
| |||||||||||||||
| Abbvie |
| |||||||||||||||
| Adhera |
| |||||||||||||||
| Allergan |
| |||||||||||||||
| Ani Pharms |
| |||||||||||||||
| Azurity |
| |||||||||||||||
| Boehringer Ingelheim |
| |||||||||||||||
| Cosette |
| |||||||||||||||
| Noden Pharma |
| |||||||||||||||
| Novartis |
| |||||||||||||||
| Waylis Therap |
| |||||||||||||||
About Inspra
Inspra is a drug owned by Upjohn Us 2 Llc. It is used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor. Inspra uses Eplerenone as an active ingredient. Inspra was launched by Upjohn in 2002.
Approval Date:
Inspra was approved by FDA for market use on 27 September, 2002.
Active Ingredient:
Inspra uses Eplerenone as the active ingredient. Check out other Drugs and Companies using Eplerenone ingredient
Treatment:
Inspra is used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor.
Dosage:
Inspra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Discontinued | ORAL |
| 50MG | TABLET | Prescription | ORAL |