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Generated: October 18, 2017
What is the patent landscape for 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.| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 45 |
| Clinical Trials: see list | 1 |
| Patent Applications: see list | 3,506 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | SKYLA at DailyMed |
| Ingredient-type | Progesterone Congeners |
| Drug Class | Progestin Progestin-containing Intrauterine Device |
| Physiological Effect | Inhibit Ovum Fertilization |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | SKYLA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 203159-001 | Jan 9, 2013 | ► Subscribe | ► Subscribe | ||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,452,082 | Inserter | ► Subscribe | |||||||||||||
| D791318 | Inserter | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 1539063 | ► Subscribe | |||||||||||||
| Costa Rica | 7709 | ► Subscribe | |||||||||||||
| China | 1310627 | ► Subscribe | |||||||||||||
| Russian Federation | 2011115057 | ► Subscribe | |||||||||||||
| Japan | 5390618 | ► Subscribe | |||||||||||||
| Mexico | PA05002718 | ► Subscribe | |||||||||||||
| Poland | 374112 | ► Subscribe | |||||||||||||
| Spain | 2424984 | ► Subscribe | |||||||||||||
| European Patent Office | 1400258 | ► Subscribe | |||||||||||||
| Canada | 2736020 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016 00016 | Denmark | ► Subscribe | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 | ||||||||||||
| 156 | Luxembourg | ► Subscribe | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 | ||||||||||||
| 0814 | Netherlands | ► Subscribe | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 | ||||||||||||
| 2015000093 | Germany | ► Subscribe | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 | ||||||||||||
| /2015 | Austria | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 | ||||||||||||
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Serving leading biopharmaceutical companies globally:
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 verifification 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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