Quartette is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 2 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 11, 2029. Details of Quartette'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). | |||
| US8415332 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens |
Mar, 2029
(4 years from now) | Active |
| US8450299 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens |
Oct, 2025
(10 months from now) | Active |
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 Quartette's patents.
Latest Legal Activities on Quartette's Patents
Given below is the list of recent legal activities going on the following patents of Quartette.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Nov, 2020 | US8450299 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2020 | US8415332 (Litigated) |
| Mail-Petition Decision - Dismissed Critical | 23 Jun, 2014 | US8415332 (Litigated) |
| Petition Decision - Dismissed Critical | 23 Jun, 2014 | US8415332 (Litigated) |
| Adjustment of PTA Calculation by PTO | 21 Jun, 2014 | US8415332 (Litigated) |
| Petition Entered | 10 Jun, 2013 | US8415332 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 May, 2013 | US8450299 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 28 May, 2013 | US8450299 (Litigated) |
| Issue Notification Mailed Critical | 08 May, 2013 | US8450299 (Litigated) |
| Dispatch to FDC | 30 Apr, 2013 | US8450299 (Litigated) |
FDA has granted several exclusivities to Quartette. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Quartette, 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 Quartette.
Exclusivity Information
Quartette holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Quartette's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 28, 2016 |
US patents provide insights into the exclusivity only within the United States, but Quartette 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 Quartette's family patents as well as insights into ongoing legal events on those patents.
Quartette's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Quartette's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 11, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Quartette Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Quartette. 16 different companies have already filed for the generic of Quartette, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Quartette's generic
How can I launch a generic of Quartette before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Quartette's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Quartette'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 Quartette -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg | 10 Jul, 2013 | 1 | Extinguished |
Alternative Brands for Quartette
Quartette which is used for contraception., has several other brand drugs in the same treatment category and using the same active ingredient (Ethinyl Estradiol; Levonorgestrel). 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 |
| |||||||||||
| Bayer Hlthcare |
| |||||||||||
| Evofem Inc |
| |||||||||||
| Organon |
| |||||||||||
| Teva Branded Pharm |
| |||||||||||
| Wyeth Pharms Inc |
| |||||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ethinyl Estradiol; Levonorgestrel. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Agile |
| |
| Avion Pharms |
| |
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Levonorgestrel, Quartette's active ingredient. Check the complete list of approved generic manufacturers for Quartette
About Quartette
Quartette is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for contraception. Quartette uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Quartette was launched by Teva Branded Pharm in 2013.
Approval Date:
Quartette was approved by FDA for market use on 28 March, 2013.
Active Ingredient:
Quartette uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Quartette is used for contraception.
Dosage:
Quartette is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | TABLET | Prescription | ORAL |