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Ethinyl estradiol; etonogestrel - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ethinyl estradiol; etonogestrel?

Ethinyl estradiol; etonogestrel is the generic ingredient in one branded drug marketed by Organon Usa Inc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; etonogestrel has thirty-one patent family members in twenty-four countries.

There are twenty-six drug master file entries for ethinyl estradiol; etonogestrel. Four suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; etonogestrel

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list26
Suppliers / Packagers: see list4
Clinical Trials: see list281
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; etonogestrel at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; etonogestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc
NUVARING
ethinyl estradiol; etonogestrel
RING;VAGINAL021187-001Oct 3, 2001RXYesYes5,989,581► Subscribe ► Subscribe
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International Patent Family for Ingredient: ethinyl estradiol; etonogestrel

Country Document Number Estimated Expiration
Germany69803112► Subscribe
Singapore65061► Subscribe
Israel123813► Subscribe
Australia726934► Subscribe
China1163222► 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 Certificates for Tradename: ETHINYL ESTRADIOL; ETONOGESTREL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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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 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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