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 nineteen patent family members in twelve countries.
The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TWIRLA?
- What are the global sales for TWIRLA?
- What is Average Wholesale Price for TWIRLA?
Summary for TWIRLA
International Patents: | 19 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Patent Applications: | 460 |
Drug Prices: | Drug price information for TWIRLA |
What excipients (inactive ingredients) are in TWIRLA? | TWIRLA excipients list |
DailyMed Link: | TWIRLA at DailyMed |


Pharmacology for TWIRLA
Drug Class | Estrogen Progestin Progestin-containing Intrauterine System |
Mechanism of Action | Estrogen Receptor Agonists |
Physiological Effect | Inhibit Ovum Fertilization |
US Patents and Regulatory Information for TWIRLA
TWIRLA is protected by three US patents.
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 | 8,747,888 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | 8,246,978 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | 9,050,348 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 | 8,221,784 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 7,045,145 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 8,883,196 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 8,221,785 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 7,384,650 | ⤷ Try for Free |
>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
Patent: Dermal delivery device with in situ seal
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0814697
Patent: dispositivo de liberação dérmica com uma vedação no local
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 92884
Patent: DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINTIN SITU (Dermal delivery device with in situ seal)
Estimated Expiration: ⤷ Try for Free
China
Patent: 1801321
Patent: Dermal delivery device with in situ seal
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 0208
Patent: УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Estimated Expiration: ⤷ Try for Free
Patent: 1070123
Patent: УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 67001
Patent: DISPOSITIF D'ADMINISTRATION THERMIQUE AVEC SOUDURE ULTRASONORE (DERMAL DELIVERY DEVICE WITH ULTRASONIC WELD)
Estimated Expiration: ⤷ Try for Free
Patent: 67002
Patent: DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINT IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Estimated Expiration: ⤷ Try for Free
Georgia, Republic of
Patent: 0125717
Patent: DEVICE FOR MEDICINE DIRECT DERMAL DELIVERY
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 42798
Patent: 具有原位密封的皮膚遞送裝置 (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 03235
Estimated Expiration: ⤷ Try for Free
Patent: 72725
Estimated Expiration: ⤷ Try for Free
Patent: 10533199
Estimated Expiration: ⤷ Try for Free
Patent: 14159468
Patent: DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 2565
Patent: DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 81652
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Japan | 2014159468 | DERMAL DELIVERY DEVICE WITH IN SITU SEAL | ⤷ Try for Free |
Brazil | 0015802 | Sistema de administração de contraceptivo transdérmico, e, método para controlar a fertilidade, e para produzir um sistema de administração de contracptivo transdérmico | ⤷ Try for Free |
China | 101897683 | Transdermal hormone delivery system: compositions and methods | ⤷ Try for Free |
European Patent Office | 2167001 | DISPOSITIF D'ADMINISTRATION THERMIQUE AVEC SOUDURE ULTRASONORE (DERMAL DELIVERY DEVICE WITH ULTRASONIC WELD) | ⤷ Try for Free |
Israel | 173152 | TRANSDERMAL HORMONE DELIVERY SYSTEM AND METHOD FOR ITS MANUFACTURE | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2009009651 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TWIRLA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1214076 | SZ 49/2008 | Austria | ⤷ Try for Free | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
1453521 | 93156 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
1453521 | 122015000093 | Germany | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
1380301 | 2009C/007 | Belgium | ⤷ Try for Free | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
1453521 | 15C0050 | France | ⤷ Try for Free | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
1453521 | 300814 | Netherlands | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Twirla
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