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Last Updated: May 19, 2022

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

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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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
AstraZeneca
Dow
McKesson
Merck

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.