Estradiol - Generic Drug Details
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What are the generic drug sources for estradiol and what is the scope of freedom to operate?
Estradiol
is the generic ingredient in forty-two branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco Labs Llc, Teva Pharms Usa, Bayer Hlthcare, Amneal, Mylan Technologies, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Chemo Research Sl, Pfizer, Therapeuticsmd Inc, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Zydus Noveltech Inc, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma, Lannett Co Inc, Mayne Pharma, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Am Regent, Fosun Pharma, Hikma, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Myovant Sciences, and Teva Womens, and is included in seventy-seven NDAs. There are fifty-three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Estradiol has two hundred and fifty-two patent family members in twenty-nine countries.
There are seventy-five drug master file entries for estradiol. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for estradiol
International Patents: | 252 |
US Patents: | 53 |
Tradenames: | 42 |
Applicants: | 52 |
NDAs: | 77 |
Drug Master File Entries: | 75 |
Finished Product Suppliers / Packagers: | 39 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Clinical Trials: | 965 |
Patent Applications: | 7,475 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for estradiol |
Drug Sales Revenues: | Drug sales revenues for estradiol |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for estradiol |
What excipients (inactive ingredients) are in estradiol? | estradiol excipients list |
DailyMed Link: | estradiol at DailyMed |
Recent Clinical Trials for estradiol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Maryland, Baltimore | Early Phase 1 |
Karolinska University Hospital | N/A |
CRG UZ Brussel | N/A |
Generic filers with tentative approvals for ESTRADIOL
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 3MG;2MG;3MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 1MG;2MG;2MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for estradiol
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for estradiol
Paragraph IV (Patent) Challenges for ESTRADIOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
IMVEXXY | Vaginal Inserts | estradiol | 4 mcg and 10 mcg | 208564 | 1 | 2019-12-30 |
MINIVELLE | Transdermal System | estradiol | 0.025 mg/day | 203752 | 1 | 2015-05-08 |
MINIVELLE | Transdermal System | estradiol | 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day | 203752 | 1 | 2014-08-18 |
VAGIFEM | Vaginal Tablets | estradiol | 10 mcg | 020908 | 1 | 2013-01-02 |
VIVELLE-DOT | Transdermal System | estradiol | 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day | 020538 | 1 | 2010-04-27 |
CLIMARA | Transdermal System | estradiol | 0.05 mg/day and 0.1 mg/day | 020375 | 2005-09-12 |
US Patents and Regulatory Information for estradiol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Us | EVAMIST | estradiol | SPRAY;TRANSDERMAL | 022014-001 | Jul 27, 2007 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 estradiol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-002 | Dec 22, 1994 | See Plans and Pricing | See Plans and Pricing |
Pfizer | ESTRING | estradiol | INSERT, EXTENDED RELEASE;VAGINAL | 020472-001 | Apr 26, 1996 | See Plans and Pricing | See Plans and Pricing |
Allergan | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-003 | Dec 20, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for estradiol
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6682127 | See Plans and Pricing | |
Germany | 10179223 | See Plans and Pricing | |
South Korea | 20110039331 | TRANSDERMAL ESTROGEN DEVICE AND DELIVERY | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for estradiol
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1380301 | CA 2009 00017 | Denmark | See Plans and Pricing | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
0771217 | CA 2006 00038 | Denmark | See Plans and Pricing | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
0398460 | 12/2004 | Austria | See Plans and Pricing | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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