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Last Updated: April 24, 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-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.

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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

Supplementary Protection Certificates for SKYLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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