Angeliq Patent Expiration

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

(7 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.

Given below is the list of recent legal activities going on the following patents of Angeliq.

Activity Date Patent Number
Patent litigations
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 09 Dec, 2014 US8906890
Patent Issue Date Used in PTA Calculation 09 Dec, 2014 US8906890
Email Notification 21 Nov, 2014 US8906890
Issue Notification Mailed 19 Nov, 2014 US8906890
Dispatch to FDC 06 Nov, 2014 US8906890
Application Is Considered Ready for Issue 05 Nov, 2014 US8906890
Issue Fee Payment Verified 04 Nov, 2014 US8906890
Issue Fee Payment Received 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

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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

Angeliq has patent protection in a total of 16 countries. It's US patent count contributes only to 14.3% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Angeliq.

Family Patents

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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