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Generated: July 25, 2017
What are the generic drug sources for estradiol and what is the scope of estradiol patent protection?
Estradiol is the generic ingredient in thirty-eight branded drugs marketed by Bristol Myers Squibb, Novo Nordisk Inc, Duramed Pharms Barr, Mylan Speciality Lp, Perrigo Pharma Intl, Mayne Pharma, Parke Davis, Novartis, Mylan, Vertical Pharms Llc, Lannett Holdings Inc, Women First Hlthcare, Ortho Mcneil Pharm, Noven, Allergan Sales Llc, Amneal Pharms, Ascend Theraps Us, Pharmacia And Upjohn, Bayer Hlthcare, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz Inc, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Mylan Labs Ltd, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-eight NDAs. There are eighteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 38 |
| Patents: | 18 |
| Applicants: | 39 |
| NDAs: | 58 |
| Drug Master File Entries: see list | 75 |
| Suppliers / Packagers: see list | 48 |
| Bulk Api Vendors: see list | 63 |
| Clinical Trials: see list | 673 |
| Patent Applications: see list | 9,857 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | estradiol at DailyMed |
| Ingredient-type | Estradiol Congeners |
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 1MG;2MG;2MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 3MG;2MG;3MG | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | MENOSTAR | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 021674-001 | Jun 8, 2004 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-003 | Oct 29, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Novartis | ESTRADERM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 019081-003 | Sep 10, 1986 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Sandoz Inc | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 040628-003 | Oct 4, 2007 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | VIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-001 | Dec 20, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | VIVELLE-DOT | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020538-009 | May 3, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Women First Hlthcare | ESCLIM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020847-002 | Aug 4, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Novartis | VIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,980,290 | Transdermal compositions for anticholinergic agents | ► Subscribe | |||||||||||||||||||||||||||
| 7,387,789 | Transdermal delivery of non-steroidal anti-inflammatory drugs | ► Subscribe | |||||||||||||||||||||||||||
| 7,438,203 | Dermal penetration enhancers and drug delivery systems involving same | ► Subscribe | |||||||||||||||||||||||||||
| 6,964,777 | Transdermal delivery of antianxiety agents | ► Subscribe | |||||||||||||||||||||||||||
| 8,071,075 | Dermal penetration enhancers and drug delivery systems involving the same | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69739037 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 524423 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 324865 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1155942 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1101553 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 972 | Luxembourg | ► Subscribe | 91972, EXPIRES: 20220219 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| /2004 | Austria | ► Subscribe | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 | ||||||||||||||||||||||||||
| 2012 00011 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
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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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