Duavee is a drug owned by Wyeth Pharmaceuticals Llc. It is protected by 5 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 4 have expired. Duavee's patents have been open to challenges since 13 October, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 10, 2027. Details of Duavee'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. | |||
| US7683051 | Crystalline polymorph of bazedoxifene acetate |
Mar, 2027
(1 year, 9 months from now) | Active |
| US5998402 | 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents |
Apr, 2019
(6 years ago) |
Expired
|
| US7138392 | 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents |
Apr, 2017
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6479535 | 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations |
May, 2024
(1 year, 5 days ago) |
Expired
|
| US8815934 | 2-Phenyl-1-[4-(2-Aminoethoxy)-Benzyl]-Indole and estrogen formulations |
May, 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 Duavee's patents.
Latest Legal Activities on Duavee's Patents
Given below is the list of recent legal activities going on the following patents of Duavee.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 03 Oct, 2022 | US8815934 |
| Maintenance Fee Reminder Mailed Critical | 18 Apr, 2022 | US8815934 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Aug, 2021 | US7683051 |
| Expire Patent Critical | 24 Dec, 2018 | US7138392 |
| Maintenance Fee Reminder Mailed Critical | 02 Jul, 2018 | US7138392 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jan, 2018 | US8815934 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Aug, 2017 | US7683051 |
| Change in Power of Attorney (May Include Associate POA) Critical | 08 May, 2017 | US7138392 |
| Email Notification Critical | 08 May, 2017 | US7138392 |
| Correspondence Address Change Critical | 05 May, 2017 | US7138392 |
FDA has granted several exclusivities to Duavee. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Duavee, 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 Duavee.
Exclusivity Information
Duavee holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Duavee's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 03, 2016 |
| New Chemical Entity Exclusivity(NCE) | Oct 13, 2018 |
US patents provide insights into the exclusivity only within the United States, but Duavee 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 Duavee's family patents as well as insights into ongoing legal events on those patents.
Duavee's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Duavee's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 10, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duavee Generics:
There are no approved generic versions for Duavee as of now.
Alternative Brands for Duavee
Duavee which is used for management of menopausal symptoms and prevention of osteoporosis., 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 |
| |||
| Aspen |
| |||
| Bayer Hlthcare |
| |||
| Legacy Pharma |
| |||
About Duavee
Duavee is a drug owned by Wyeth Pharmaceuticals Llc. It is used for management of menopausal symptoms and prevention of osteoporosis. Duavee uses Bazedoxifene Acetate; Estrogens, Conjugated as an active ingredient. Duavee was launched by Wyeth Pharms in 2013.
Approval Date:
Duavee was approved by FDA for market use on 03 October, 2013.
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 Duavee is 03 October, 2013, its NCE-1 date is estimated to be 13 October, 2017.
Active Ingredient:
Duavee uses Bazedoxifene Acetate; Estrogens, Conjugated as the active ingredient. Check out other Drugs and Companies using Bazedoxifene Acetate; Estrogens, Conjugated ingredient
Treatment:
Duavee is used for management of menopausal symptoms and prevention of osteoporosis.
Dosage:
Duavee is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE;0.45MG | TABLET | Prescription | ORAL |