KYLEENA Drug Patent Profile
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Which 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 five patents protecting this drug.
This drug has seventy-nine patent family members in twenty-eight countries.
The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kyleena
A generic version of KYLEENA was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.
Summary for KYLEENA
International Patents: | 79 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 3 |
Patent Applications: | 3,959 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KYLEENA |
What excipients (inactive ingredients) are in KYLEENA? | KYLEENA excipients list |
DailyMed Link: | KYLEENA at DailyMed |


Recent Clinical Trials for KYLEENA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Arkansas Children's Hospital Research Institute | Phase 4 |
Biós Farmacêutica | Phase 2 |
Science Valley Research Institute | Phase 2 |
Pharmacology for KYLEENA
Drug Class | Progestin Progestin-containing Intrauterine Device |
Physiological Effect | Inhibit Ovum Fertilization |
Anatomical Therapeutic Chemical (ATC) Classes for KYLEENA
US Patents and Regulatory Information for KYLEENA
KYLEENA is protected by five US patents.
Patents protecting KYLEENA
Inserter
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM (IUS) BY DETERMINING A DEPTH OF THE UTERUS, HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE IUS INTO THE UTERUS
Inserter
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Delivery system and a manufacturing process of a delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Inserter
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF POSITIONING AN INTRAUTERINE SYSTEM BY HOLDING AN INSERTER HANDLE WITH ONE HAND, ADVANCING THE INSERTER THROUGH THE CERVIX AND INTO THE UTERUS, AND RETRACTING A SLIDER ON THE HANDLE TO RELEASE THE INTRAUTERINE SYSTEM
Inserter
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
See the table below for patents covering KYLEENA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI0314287 | processo de manufatura de um sistema de distribuição | ⤷ Try a Trial |
Norway | 331466 | ⤷ Try a Trial | |
China | 102159160 | Inserter | ⤷ Try a Trial |
South Korea | 20110083598 | AN INSERTER | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KYLEENA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1453521 | C201630040 | Spain | ⤷ Try a Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
1453521 | 15C0050 | France | ⤷ Try a 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 | 93156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |