KYLEENA Drug Patent Profile
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When do Kyleena patents expire, and what generic alternatives are available?
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-seven patent family members in thirty countries.
The generic ingredient in KYLEENA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five 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.
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Summary for KYLEENA
| International Patents: | 77 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 3 |
| Patent Applications: | 3,688 |
| 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 |
| Science Valley Research Institute | Phase 2 |
| Biós Farmacêutica | Phase 2 |
Pharmacology for KYLEENA
| Drug Class | Progestin Progestin-containing Intrauterine System |
| Physiological Effect | Inhibit Ovum Fertilization |
US Patents and Regulatory Information for KYLEENA
KYLEENA is protected by three US patents.
Patents protecting KYLEENA
Inserter
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF PREVENTING PREGNANCY BY PROVIDING AN INTRAUTERINE SYSTEM (IUS), HOLDING AN INSERTER HANDLE WITH ONE HAND, INSERTING THE IUS INTO THE UTERUS, AND MOVING A SLIDER IN THE HANDLE TO RELEASE THE IUS WITHIN THE UTERUS
| 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 | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 KYLEENA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | KYLEENA | levonorgestrel | SYSTEM;INTRAUTERINE | 208224-001 | Sep 16, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KYLEENA
See the table below for patents covering KYLEENA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012502713 | ⤷ Sign Up | |
| Hong Kong | 1076023 | A delivery system and a manufacturingprocess of a system | ⤷ Sign Up |
| Japan | 5264475 | ⤷ Sign Up | |
| Russian Federation | 2297810 | СИСТЕМА ДОСТАВКИ И СПОСОБ ПРОИЗВОДСТВА СИСТЕМЫ ДОСТАВКИ (DELIVERY SYSTEM AND METHOD FOR PRODUCING THE SYSTEM) | ⤷ Sign Up |
| Poland | 374112 | Układ doprowadzający i sposób wytwarzania układu doprowadzającego (A DELIVERY SYSTEM AND A MANUFACTURING PROCESS OF A DELIVERY SYSTEM) | ⤷ Sign Up |
| Russian Federation | 2389451 | ОБНАРУЖИВАЕМАЯ С ПОМОЩЬЮ УЛЬТРАЗВУКА ВНУТРИМАТОЧНАЯ СИСТЕМА И СПОСОБ УЛУЧШЕНИЯ УЛЬТРАЗВУКОВОГО ОБНАРУЖЕНИЯ (ULTRASOUND DETECTED INTRAUTERINE SYSTEM AND METHOD FOR ULTRASONIC DETECTION ENHANCEMENT) | ⤷ Sign Up |
| Denmark | 1539063 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KYLEENA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | C201630040 | Spain | ⤷ Sign Up | 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 | 122015000093 | Germany | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| 1453521 | 39/2015 | Austria | ⤷ Sign Up | 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 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | 15C0050 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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