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TWIRLA Drug 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 seven patents protecting this drug.
This drug has fifty-eight patent family members in twenty-three 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: | 58 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in TWIRLA? | TWIRLA excipients list |
| DailyMed Link: | TWIRLA at DailyMed |
US Patents and Regulatory Information for TWIRLA
| 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 | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 | Get Started for $10 | Get Started for $10 |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | Get Started for $10 | Get Started for $10 |
| Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TWIRLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1142798 | Get Started for $10 |
| Australia | 1788301 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 0137770 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TWIRLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | C01214076/01 | Switzerland | Get Started for $10 | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 1380301 | CA 2009 00017 | Denmark | Get Started for $10 | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 1453521 | 122015000093 | Germany | Get Started for $10 | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
