Angeliq is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 22, 2031. Details of Angeliq'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). | |||
| US8906890 | Very low-dosed solid oral dosage forms for HRT |
Oct, 2031
(6 years from now) | Active |
| US6933395 | PROCESSING FOR PRODUCING OF DROSPIRENONE (6β, 7β, 15β, 16β-DIMETHYLENE-3-OXO-17α-PREGN-4-EN-21, 17-CARBOLACTONE, DRSP) AS WELL AS 7α-(3-HYDOXY-1-PROPLY)-6β, 7β; 15β, 16β-DIMETHYLENE-5β-ANDROSTANE-3β, 5,17β-TRIOL(ZK 92836) AND 6β, 7β; 15β, 16β-DIMETHYLENE-5β-HYDROXY |
Aug, 2017
(7 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 Angeliq's patents.
Latest Legal Activities on Angeliq's Patents
Given below is the list of recent legal activities going on the following patents of Angeliq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 May, 2022 | US8906890 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 May, 2018 | US8906890 |
| Recordation of Patent Grant Mailed Critical | 09 Dec, 2014 | US8906890 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Dec, 2014 | US8906890 |
| Email Notification Critical | 21 Nov, 2014 | US8906890 |
| Issue Notification Mailed Critical | 19 Nov, 2014 | US8906890 |
| Dispatch to FDC | 06 Nov, 2014 | US8906890 |
| Application Is Considered Ready for Issue Critical | 05 Nov, 2014 | US8906890 |
| Issue Fee Payment Verified Critical | 04 Nov, 2014 | US8906890 |
| Issue Fee Payment Received Critical | 04 Nov, 2014 | US8906890 |
FDA has granted several exclusivities to Angeliq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Angeliq, 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 Angeliq.
Exclusivity Information
Angeliq holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Angeliq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Mar 01, 2015 |
US patents provide insights into the exclusivity only within the United States, but Angeliq 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 Angeliq's family patents as well as insights into ongoing legal events on those patents.
Angeliq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Angeliq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 22, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Angeliq Generics:
There are no approved generic versions for Angeliq as of now.
How can I launch a generic of Angeliq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Angeliq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Angeliq'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 Angeliq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg/1 mg | 26 Dec, 2007 | 1 | 11 Aug, 2017 | Extinguished | |
| 0.25 mg/0.5 mg | 08 Jan, 2015 | 1 | 22 Oct, 2031 | Extinguished |
About Angeliq
Angeliq is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Angeliq uses Drospirenone; Estradiol as an active ingredient. Angeliq was launched by Bayer Hlthcare in 2012.
Approval Date:
Angeliq was approved by FDA for market use on 29 February, 2012.
Active Ingredient:
Angeliq uses Drospirenone; Estradiol as the active ingredient. Check out other Drugs and Companies using Drospirenone; Estradiol ingredient
Dosage:
Angeliq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25MG;0.5MG | TABLET | Prescription | ORAL |
| 0.5MG;1MG | TABLET | Prescription | ORAL |