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Generated: June 26, 2017
What is the patent landscape for Loseasonique, and what generic Loseasonique alternatives are available?
Loseasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 3 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | LOSEASONIQUE at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | 7,858,605 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | 7,855,190 | ► Subscribe | ► Subscribe | |||||||||||||||||
Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | AB | RX | No | No | 7,615,545 | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| levonorgestrel;ethinyl estradiol;ethinyl estradiol | Tablets | 0.1 mg/0.02 mg and 0.01 mg | LoSeasonique | 11/16/2009 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,772,219 | Methods of hormonal treatment utilizing extended cycle contraceptive regimens | ► Subscribe | |||||||||||||||||||||||||||
| 7,320,969 | Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology | ► Subscribe | |||||||||||||||||||||||||||
| 8,680,084 | Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology | ► Subscribe | |||||||||||||||||||||||||||
| 8,338,396 | Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 213122 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2010201022 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 555299 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2004098517 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2351339 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0160011 00192 | Estonia | ► Subscribe | PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015 | ||||||||||||||||||||||||||
| 1214076/01 | Switzerland | ► Subscribe | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 | ||||||||||||||||||||||||||
| 00C/027 | Belgium | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 | ||||||||||||||||||||||||||
| 0814 | Netherlands | ► Subscribe | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 | ||||||||||||||||||||||||||
| 2006 00038 | Denmark | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 | ||||||||||||||||||||||||||
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Serving 500+ 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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