TWIRLA Drug Patent Profile
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Which patents cover Twirla, and what generic alternatives are available?
Twirla is a drug marketed by Agile and is included in one NDA. There are three patents protecting this drug.
This drug has eighteen patent family members in eleven countries.
The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
DrugPatentWatch® Generic Entry Outlook for Twirla
There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TWIRLA
International Patents: | 18 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Patent Applications: | 414 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in TWIRLA? | TWIRLA excipients list |
DailyMed Link: | TWIRLA at DailyMed |

Anatomical Therapeutic Chemical (ATC) Classes for TWIRLA
US Patents and Regulatory Information for TWIRLA
TWIRLA is protected by three US patents and one FDA Regulatory Exclusivity.
Patents protecting TWIRLA
Dermal delivery device with reduced loss of its volatile components
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dermal delivery device with in situ seal
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Dermal delivery device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting TWIRLA
NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TWIRLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | See Plans and Pricing | See Plans and Pricing |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | See Plans and Pricing | See Plans and Pricing |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | See Plans and Pricing | See Plans and Pricing |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | See Plans and Pricing | See Plans and Pricing |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TWIRLA
When does loss-of-exclusivity occur for TWIRLA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 08275101
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0814697
Estimated Expiration: See Plans and Pricing
Canada
Patent: 92884
Estimated Expiration: See Plans and Pricing
China
Patent: 1801321
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 0208
Estimated Expiration: See Plans and Pricing
Patent: 1070123
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 67001
Estimated Expiration: See Plans and Pricing
Patent: 67002
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 42798
Estimated Expiration: See Plans and Pricing
Japan
Patent: 03235
Estimated Expiration: See Plans and Pricing
Patent: 72725
Estimated Expiration: See Plans and Pricing
Patent: 10533199
Estimated Expiration: See Plans and Pricing
Patent: 14159468
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 2565
Estimated Expiration: See Plans and Pricing
Spain
Patent: 81652
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TWIRLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200203525 | Transdermal contraceptive delivery system and process. | See Plans and Pricing |
Spain | 2581652 | See Plans and Pricing | |
Japan | 2010533199 | See Plans and Pricing | |
China | 1835722 | Transdermal hormone delivery system: compositions and methods | See Plans and Pricing |
China | 101897683 | Transdermal hormone delivery system: compositions and methods | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TWIRLA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1380301 | 2009C/007 | Belgium | See Plans and Pricing | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
1214076 | C01214076/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
1453521 | 122015000093 | Germany | See Plans and Pricing | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
0398460 | C300221 | Netherlands | See Plans and Pricing | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
1453521 | 93156 | Luxembourg | See Plans and Pricing | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |