Twirla is a drug owned by Agile Therapeutics Inc. It is protected by 8 US drug patents filed in 2020. Out of these, 3 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 26, 2028. Details of Twirla'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). | |||
| US8246978 | Dermal delivery device with reduced loss of its volatile components |
Aug, 2028
(3 years from now) | Active |
| US9050348 | Dermal delivery device |
Jul, 2028
(3 years from now) | Active |
| US8747888 | Dermal delivery device with in situ seal |
Jul, 2028
(3 years from now) | Active |
| US8221785 | Transdermal hormone delivery system: compositions and methods |
Mar, 2021
(4 years ago) |
Expired
|
| US8221784 | Transdermal hormone delivery system: compositions and methods |
Mar, 2021
(4 years ago) |
Expired
|
| US7045145 | Transdermal contraceptive delivery system and process |
Mar, 2021
(4 years ago) |
Expired
|
| US7384650 | Skin permeation enhancement composition for transdermal hormone delivery system |
Mar, 2021
(4 years ago) |
Expired
|
| US8883196 | Transdermal hormone delivery system: compositions and methods |
Nov, 2020
(4 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 Twirla's patents.
Latest Legal Activities on Twirla's Patents
Given below is the list of recent legal activities going on the following patents of Twirla.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 04 Mar, 2024 | US8221785 |
| Maintenance Fee Reminder Mailed Critical | 04 Mar, 2024 | US8221784 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 21 Feb, 2024 | US8246978 |
| Expire Patent Critical | 19 Dec, 2022 | US8883196 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 09 Dec, 2022 | US9050348 |
| Maintenance Fee Reminder Mailed Critical | 04 Jul, 2022 | US8883196 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Feb, 2020 | US8246978 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 Jan, 2020 | US8221785 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 Jan, 2020 | US8221784 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 10 Dec, 2019 | US7384650 |
FDA has granted several exclusivities to Twirla. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Twirla, 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 Twirla.
Exclusivity Information
Twirla holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Twirla's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 14, 2023 |
US patents provide insights into the exclusivity only within the United States, but Twirla 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 Twirla's family patents as well as insights into ongoing legal events on those patents.
Twirla's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Twirla's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 26, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Twirla Generic API suppliers:
Ethinyl Estradiol; Levonorgestrel is the generic name for the brand Twirla. 16 different companies have already filed for the generic of Twirla, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Twirla's generic
Alternative Brands for Twirla
Twirla which is used for contraception via transdermal method., has several other brand drugs 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 | |||||
|---|---|---|---|---|---|---|
| Avion Pharms |
| |||||
| Teva Branded Pharm |
| |||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ethinyl Estradiol; Levonorgestrel, Twirla's active ingredient. Check the complete list of approved generic manufacturers for Twirla
About Twirla
Twirla is a drug owned by Agile Therapeutics Inc. It is used for contraception via transdermal method. Twirla uses Ethinyl Estradiol; Levonorgestrel as an active ingredient. Twirla was launched by Agile in 2020.
Approval Date:
Twirla was approved by FDA for market use on 14 February, 2020.
Active Ingredient:
Twirla uses Ethinyl Estradiol; Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Levonorgestrel ingredient
Treatment:
Twirla is used for contraception via transdermal method.
Dosage:
Twirla is available in system form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.03MG/24HR;0.12MG/24HR | SYSTEM | Prescription | TRANSDERMAL |