Evista is a drug owned by Eli Lilly And Co. It is protected by 13 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 Mar 10, 2017. Details of Evista'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). | |||
| US8030330 | Benzothiophenes, formulations containing same, and methods |
Mar, 2017
(8 years ago) |
Expired
|
| US6894064 | Benzothiophenes, formulations containing same, and methods |
Mar, 2017
(8 years ago) |
Expired
|
| US6458811 | Benzothiophenes formulations containing same and methods |
Mar, 2017
(8 years ago) |
Expired
|
| US6797719 | Benzothiophenes, formulations containing same, and methods |
Mar, 2017
(8 years ago) |
Expired
|
| US5811120 | Solid orally administerable raloxifene hydrochloride pharmaceutical formulation |
Mar, 2014
(11 years ago) |
Expired
|
| US5972383 | Solid orally administerable raloxifene hydrochloride pharmaceutical formulation |
Mar, 2014
(11 years ago) |
Expired
|
| US5478847 | Methods of use for inhibiting bone loss and lowering serum cholesterol |
Mar, 2014
(11 years ago) |
Expired
|
| USRE39050 | Methods of use for inhibiting bone loss and lowering serum cholesterol |
Mar, 2014
(11 years ago) |
Expired
|
| US5393763 | Methods for inhibiting bone loss |
Jul, 2012
(13 years ago) |
Expired
|
| US6906086 | Methods for inhibiting bone loss |
Jul, 2012
(13 years ago) |
Expired
|
| US5457117 | Method for inhibiting bone loss using 6-hydroxy-2-(4-hydroxyphenyl)-benzo[B][2-(piperidin-1-yl)ethoxyphenylimethanone hydrochloride |
Jul, 2012
(13 years ago) |
Expired
|
| USRE39049 | Methods for inhibiting bone loss |
Jul, 2012
(13 years ago) |
Expired
|
| USRE38968 | Methods for inhibiting bone loss using 6-hydroxy-2-(4-hydroxyphenyl)-benzo[b]thien-3-yl-4-[2-(piperidin-1-yl) ethoxyphenylimethanone hydrochloride |
Jul, 2012
(13 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 Evista's patents.
Latest Legal Activities on Evista's Patents
Given below is the list of recent legal activities going on the following patents of Evista.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 11 Nov, 2019 | US8030330 |
| Maintenance Fee Reminder Mailed
Critical | 27 May, 2019 | US8030330 |
| Expire Patent
Critical | 09 Jun, 2017 | US6894064 |
| Expire Patent
Critical | 21 Oct, 2016 | US6797719 |
| Expire Patent
Critical | 12 Jul, 2013 | US6906086 |
| Recordation of Patent Grant Mailed
Critical | 04 Oct, 2011 | US8030330 |
| Patent Issue Date Used in PTA Calculation
Critical | 04 Oct, 2011 | US8030330 |
| Email Notification
Critical | 15 Sep, 2011 | US8030330 |
| Issue Notification Mailed
Critical | 14 Sep, 2011 | US8030330 |
| Email Notification
Critical | 02 Sep, 2011 | US8030330 |
FDA has granted several exclusivities to Evista. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Evista, 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
Evista.
Exclusivity Information
Evista holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Evista's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Sep 13, 2014 |
US patents provide insights into the exclusivity only within the United States, but
Evista 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 Evista's family patents as well as insights into
ongoing legal events
on those patents.
Evista's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Evista's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 10, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Evista Generic API suppliers:
Raloxifene Hydrochloride is the generic name for the brand Evista. 8 different companies have already filed for the generic of Evista, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Evista's generic
How can I launch a generic of Evista before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Evista's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Evista'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 Evista -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg |
Alternative Brands for Evista
Evista which is used for preventing and treating osteoporosis in postmenopausal women and inhibiting bone resorption, as well as for preventing breast cancer., 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 | ||||
|---|---|---|---|---|---|---|
| Apil |
| |||||
| Sandoz |
| |||||
About Evista
Evista is a drug owned by Eli Lilly And Co. It is used for preventing and treating osteoporosis in postmenopausal women and inhibiting bone resorption, as well as for preventing breast cancer. Evista uses Raloxifene Hydrochloride as an active ingredient. Evista was launched by Lilly in 1997.
Approval Date:
Evista was approved by FDA for market use on 09 December, 1997.
Active Ingredient:
Evista uses Raloxifene Hydrochloride as the active ingredient. Check out other Drugs and Companies using Raloxifene Hydrochloride ingredient
Treatment:
Evista is used for preventing and treating osteoporosis in postmenopausal women and inhibiting bone resorption, as well as for preventing breast cancer.
Dosage:
Evista is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | TABLET | Prescription | ORAL |