DrugPatentWatch Database Preview
KYLEENA Drug Profile
Email this page to a colleague
» See Plans and PricingWhich patents cover Kyleena, and when can generic versions of Kyleena launch?
Kyleena is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-eight patent family members in twenty-eight countries.
The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
US ANDA Litigation and Generic Entry Outlook for Kyleena
A generic version of KYLEENA was approved as levonorgestrel by L PERRIGO CO on December 30th, 2010.
Summary for KYLEENA
| International Patents: | 78 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Patent Applications: | 4,157 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KYLEENA |
| DailyMed Link: | KYLEENA at DailyMed |
Pharmacology for KYLEENA
| Drug Class | Progestin Progestin-containing Intrauterine Device |
| Physiological Effect | Inhibit Ovum Fertilization |
US Patents and Regulatory Information for KYLEENA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KYLEENA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1155351 | Start Trial |
| Brazil | PI0919071 | Start Trial |
| South Korea | 20110074741 | Start Trial |
| Costa Rica | 7709 | Start Trial |
| Russian Federation | 2494706 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KYLEENA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 15C0050 | France | Start Trial | 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 | 39/2015 | Austria | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 132016000025143 | Italy | Start Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
