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. Twenty 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 L PERRIGO CO on December 30th, 2010.
Summary for KYLEENA
International Patents: | 79 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 1 |
Patent Applications: | 4,435 |
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 |
---|---|
University of Oklahoma | Early Phase 1 |
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Delivery system and a manufacturing process of a delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inserter
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Bayer Hlthcare | KYLEENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 |
International Patents for KYLEENA
See the table below for patents covering KYLEENA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 100827635 | See Plans and Pricing | |
Denmark | 1539063 | See Plans and Pricing | |
European Patent Office | 1400258 | Dispositif de distribution d'une substance pharmaceutique et son procédé de fabrication (Pharmaceutical composition delivery device and its manufacturing process) | See Plans and Pricing |
>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 | See Plans and Pricing | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1453521 | 39/2015 | Austria | See Plans and Pricing | 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 | 132016000025143 | Italy | See Plans and Pricing | 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 |