Cenestin is a drug owned by Aspen Pharma Usa Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 26, 2015. Details of Cenestin'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). | |||
| US5908638 | Pharmaceutical compositions of conjugated estrogens and methods for their use |
Jul, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Cenestin 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 Cenestin's family patents as well as insights into ongoing legal events on those patents.
Cenestin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cenestin's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 26, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cenestin Generics:
There are no approved generic versions for Cenestin as of now.
How can I launch a generic of Cenestin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cenestin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cenestin'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 Cenestin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.3 mg, 0.45 mg and 0.9 mg | 19 Mar, 2009 | 1 | 26 Jul, 2015 | Extinguished | |
| 1.25 mg | 03 Nov, 2008 | 1 | 26 Jul, 2015 | Extinguished | |
| 0.625 mg | 02 Mar, 2009 | 1 | 26 Jul, 2015 | Extinguished |
About Cenestin
Cenestin is a drug owned by Aspen Pharma Usa Inc. It is used for various conditions ranging from pain management to inflammation. Cenestin uses Estrogens, Conjugated Synthetic A as an active ingredient. Cenestin was launched by Aspen in 2002.
Approval Date:
Cenestin was approved by FDA for market use on 21 June, 2002.
Active Ingredient:
Cenestin uses Estrogens, Conjugated Synthetic A as the active ingredient. Check out other Drugs and Companies using Estrogens, Conjugated Synthetic A ingredient
Treatment:
Cenestin is used for various conditions ranging from pain management to inflammation.
Dosage:
Cenestin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |