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Last Updated: November 2, 2024

SKYLA Drug Patent Profile


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Which patents cover Skyla, and when can generic versions of Skyla launch?

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-five 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.

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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: 4,912
Drug Prices: Drug price information for SKYLA
What excipients (inactive ingredients) are in SKYLA?SKYLA excipients list
DailyMed Link:SKYLA at DailyMed
Drug patent expirations by year for SKYLA
Drug Prices for SKYLA

See drug prices for SKYLA

Pharmacology for SKYLA

US Patents and Regulatory Information for SKYLA

SKYLA is protected by three US patents.

Patents protecting SKYLA

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 SKYLA levonorgestrel SYSTEM;INTRAUTERINE 203159-001 Jan 9, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bayer Hlthcare SKYLA levonorgestrel SYSTEM;INTRAUTERINE 203159-001 Jan 9, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare SKYLA levonorgestrel SYSTEM;INTRAUTERINE 203159-001 Jan 9, 2013 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

International Patents for SKYLA

See the table below for patents covering SKYLA around the world.

Country Patent Number Title Estimated Expiration
Romania 116862 INSTRUMENT PENTRU INTRODUCEREA SI POZITIONAREA UNUI DISPOZITIV INTRAUTERIN (INSTRUMENT FOR INSERTING AND POSITIONING AN INTRAUTERINE DEVICE) ⤷  Sign Up
Denmark 1539063 ⤷  Sign Up
Norway 972604 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SKYLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C 2015 029 Romania ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 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 CA 2016 00016 Denmark ⤷  Sign Up 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

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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.