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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 five patents protecting this drug.
This drug has seventy-nine patent family members in twenty-eight countries.
The generic ingredient in SKYLA is levonorgestrel. There are twenty drug master file entries for this compound. Eighteen 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 L PERRIGO CO on December 30th, 2010.
Summary for SKYLA
| International Patents: | 79 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Patent Applications: | 3,792 |
| 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 five US patents.
Patents protecting SKYLA
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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
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Delivery system and a manufacturing process of a delivery system
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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
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| 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free Trial | |||
| Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | ⤷ Sign up for a Free 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 | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SKYLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1539063 | ⤷ Sign up for a Free Trial |
| Japan | 4382668 | ⤷ Sign up for a Free Trial |
| Portugal | 2352470 | ⤷ Sign up for a Free Trial |
| World Intellectual Property Organization (WIPO) | 2010031900 | ⤷ Sign up for a Free Trial |
| China | 102159162 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SKYLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | C201630040 | Spain | ⤷ Sign up for a Free 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 | C 2015 029 | Romania | ⤷ Sign up for a Free Trial | 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 | 93156 | Luxembourg | ⤷ Sign up for a Free Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 39/2015 | Austria | ⤷ Sign up for a Free 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 | CA 2016 00016 | Denmark | ⤷ Sign up for a Free 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 |
