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-eight 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
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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: | 277 |
| 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.
Patents protecting TWIRLA
Dermal delivery device with reduced loss of its volatile components
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dermal delivery device with in situ seal
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dermal delivery device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Brazil
Patent: 0814697
Patent: dispositivo de liberação dérmica com uma vedação no local
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 92884
Patent: DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINTIN SITU (Dermal delivery device with in situ seal)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1801321
Patent: Dermal delivery device with in situ seal
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0208
Patent: УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Estimated Expiration: ⤷ Sign Up
Patent: 1070123
Patent: УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 67001
Patent: DISPOSITIF D'ADMINISTRATION THERMIQUE AVEC SOUDURE ULTRASONORE (DERMAL DELIVERY DEVICE WITH ULTRASONIC WELD)
Estimated Expiration: ⤷ Sign Up
Patent: 67002
Patent: DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINT IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0125717
Patent: DEVICE FOR MEDICINE DIRECT DERMAL DELIVERY
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Japan
Patent: 03235
Estimated Expiration: ⤷ Sign Up
Patent: 72725
Estimated Expiration: ⤷ Sign Up
Patent: 10533199
Estimated Expiration: ⤷ Sign Up
Patent: 14159468
Patent: DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2565
Patent: DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 81652
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Eurasian Patent Organization | 201070123 | УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU | ⤷ Sign Up |
| China | 101897683 | Transdermal hormone delivery system: compositions and methods | ⤷ Sign Up |
| China | 1399533 | Improved transdermal contraceptive delivery system and process | ⤷ Sign Up |
| Japan | 2003533434 | ⤷ Sign Up | |
| Japan | 4841781 | ⤷ Sign Up | |
| Eurasian Patent Organization | 020208 | УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL) | ⤷ Sign Up |
| South Korea | 20060054320 | TRANSDERMAL HORMONE DELIVERY SYSTEM: COMPOSITIONS AND METHODS | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 39/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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