SKYLA Drug Patent Profile
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When do Skyla patents expire, and what generic alternatives are available?
Skyla 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 SKYLA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Skyla
A generic version of SKYLA was approved as levonorgestrel by NOVEL LABS INC on February 22nd, 2013.
Summary for SKYLA
International Patents: | 77 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Patent Applications: | 3,892 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SKYLA |
What excipients (inactive ingredients) are in SKYLA? | SKYLA excipients list |
DailyMed Link: | SKYLA at DailyMed |
Pharmacology for SKYLA
Drug Class | Progestin Progestin-containing Intrauterine Device |
Physiological Effect | Inhibit Ovum Fertilization |
Anatomical Therapeutic Chemical (ATC) Classes for SKYLA
US Patents and Regulatory Information for SKYLA
SKYLA is protected by three US patents.
Patents protecting SKYLA
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | 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 |
Expired US Patents for SKYLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SKYLA
See the table below for patents covering SKYLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI0314287 | processo de manufatura de um sistema de distribuição | ⤷ Try a Trial |
South Korea | 101612579 | ⤷ Try a Trial | |
Germany | 60319549 | ⤷ Try a Trial | |
Mexico | 9703985 | ELEMENTO DE INSERCION PARA LA COLOCACION DE UN DISPOSITIVO INTRAUTERINO. (INSERTER FOR THE POSITIONING OF AN INTRAUTERINE DEVICE.) | ⤷ Try a Trial |
South Korea | 101264883 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SKYLA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 39/2015 | Austria | ⤷ Try a 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 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |