DrugPatentWatch Database Preview
Estradiol - Generic Drug Details
What are the generic drug sources for estradiol and what is the scope of estradiol patent protection?
Estradiol
is the generic ingredient in forty branded drugs marketed by Allergan Sales Llc, Alvogen Pine Brook, Mylan Pharms Inc, Perrigo Uk Finco, Teva Pharms Usa, Bayer Hlthcare, Women First Hlthcare, Novartis, Amneal Pharms Llc, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Therapeuticsmd Inc, Perrigo Pharma Intl, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Fosun Pharma, Luitpold, Watson Labs Inc, Savage Labs, Noven Pharms Inc, Lupin Ltd, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Womens, and is included in sixty-nine NDAs. There are twenty-seven 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 six patent family members in twenty-four countries.
There are seventy-five drug master file entries for estradiol. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for estradiol
| International Patents: | 206 |
| US Patents: | 27 |
| Tradenames: | 40 |
| Applicants: | 46 |
| NDAs: | 69 |
| Drug Master File Entries: | 75 |
| Suppliers / Packagers: | 46 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 772 |
| Patent Applications: | 7,028 |
| 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 |
| DailyMed Link: | estradiol at DailyMed |
Pharmacology for estradiol
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for estradiol
Synonyms for estradiol
| .alpha.-Oestradiol |
| .beta.-Estradiol |
| .beta.-Oestradiol |
| (+)-3,17.beta.-Estradiol |
| (+)-3,17b-Estradiol |
| (+)-3,17beta-Estradiol |
| (13S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-beta-diol |
| (17?)-Estra-1,3,5(10)-triene-3,17-diol |
| (17b)-Estra-1,3,5(10)-triene-3,17-diol |
| (17beta)-Estra-1,3,5(10)-triene-3,17-diol |
| (17beta)-estra-1(10),2,4-triene-3,17-diol |
| (1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-2(7),3,5-triene-5,14-diol |
| (1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-2,4,6-triene-5,14-diol |
| (1S,10R,11S,14S,15S)-15-methyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadeca-2,4,6-triene-5,14-diol |
| (8''R'',9''S'',13''S'',14''S'',17''S'')-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[''a'']phenanthrene-3,17-diol |
| (8R,9S,13S,14S,17S)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol |
| (8R,9S,13S,14S,17S)-13-Methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol |
| (8S,9S,13S,14S,17S)-13-Methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol |
| (9beta,13alpha,14beta,17alpha)-estra-1,3,5(10)-triene-3,17-diol |
| [2,4,6,7-3H]-17beta-estradiol |
| [2,4,6,7-3H]-E2 |
| [3H]-estradiol |
| [3H]-Estrogen |
| [3H]]estradiol |
| [3H]17beta-estradiol |
| [3H]E2 |
| [3H]estradiol |
| 003E693 |
| 1,3,5-Estratriene-3,17-beta-diol |
| 1,3,5-Estratriene-3,17.beta.-diol |
| 1,3,5-Estratriene-3,17beta-diol |
| 1,3,5,(10)-Estratrien-3,17.beta.-diol |
| 1,3,5(10)-estratriene-3,17b-diol |
| 1,5-Estratriene-3,17.beta.-diol |
| 1050677-52-5 |
| 1206475-11-7 |
| 125DP6010H |
| 13b-Methyl-1,3,5(10)-gonatriene-3,17b-ol |
| 13beta-Methyl-1,3,5(10)-gonatriene-3,17beta-ol |
| 17 ?-Estradiol |
| 17 beta-Estradiol |
| 17-.BETA.-Estradiol |
| 17-beta |
| 17-beta-Estra-1,3,5(10)-triene-3,17-diol |
| 17-beta-estradiol |
| 17-beta-Estradiol 100 microg/mL in Acetonitrile |
| 17-beta-Oestra-1,3,5(10)-triene-3,17-diol |
| 17-beta-OH-estradiol |
| 17-beta-OH-oestradiol |
| 17-decahydrocyclopenta[a]phenanthrene-3,17-diol |
| 17-E |
| 17.beta.-Estra-1,3,5(10)-triene-3,17-diol |
| 17.beta.-Estra-1,5(10)-triene-3,17-diol |
| 17.beta.-Estradiol |
| 17.beta.-Oestra-1,3,5(10)-triene-3,17-diol |
| 17.beta.-Oestra-1,5(10)-triene-3,17-diol |
| 17.beta.-Oestradiol |
| 17.beta.-OH-estradiol |
| 17.beta.-OH-oestradiol |
| 17|A-estradiol;oestradiol;17|A-Oestradiol;|A-Estradiol |
| 17|A-Oestradiol |
| 17b-Estradiol |
| 17b-Oestradiol |
| 17beta estradiol (E2) |
| 17beta oestradiol |
| 17beta-Estra-1,3,5(10)-triene-3,17-diol |
| 17beta-Estradiol |
| 17beta-estradiol (E2) |
| 17beta-Estradiol solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material |
| 17beta-Oestra-1,3,5(10)-triene-3,17-diol |
| 17beta-Oestradiol |
| 1a52 |
| 1g50 |
| 1jgl |
| 1lhu |
| 1qkt |
| 1qku |
| 2d06 |
| 2j7x |
| 3,17-.beta.-Oestradiol |
| 3,17-beta-Dihydroxy-1,3,5(10)-oestratriene |
| 3,17-beta-Dihydroxyestra-1,3,5(10)-triene |
| 3,17-beta-Dihydroxyoestra-1,3,5-triene |
| 3,17-beta-Estradiol |
| 3,17-beta-Oestradiol |
| 3,17-dihydroxy-delta(1,3,5-10)-estratriene |
| 3,17-Epidihydroxyestratriene |
| 3,17-Epidihydroxyoestratriene |
| 3,17.beta.-Dihydroxy-1,3,5(10)-estratriene |
| 3,17.beta.-Dihydroxy-1,3,5(10)-oestratriene |
| 3,17.beta.-Dihydroxyestra-1,3,5-triene |
| 3,17.beta.-Dihydroxyestra-1,3,5(10)-triene |
| 3,17.beta.-Dihydroxyoestra-1,3,5-triene |
| 3,17.beta.-Estradiol |
| 3,17b-Dihydroxyestra-1,3,5(10)-triene |
| 3,17b-Estradiol |
| 3,17beta-Dihydroxy-1,3,5(10)-estratriene |
| 3,17beta-Dihydroxyestra-1,3,5-triene |
| 3,17beta-dihydroxyestra-1,3,5(10)-trien |
| 3,17beta-Dihydroxyestra-1,3,5(10)-triene |
| 3,17beta-Dihydroxyoestra-1,3,5-triene |
| 3,17beta-Estradiol |
| 3,3,5-triene |
| 3,3,5(10)-triene |
| 4TI98Z838E |
| 50-28-2 |
| 73459-61-7 |
| 873662-39-6 |
| AB0012866 |
| AB2000237 |
| AC-22346 |
| AC1L1L2K |
| ACN-S003579 |
| Activella (Salt/Mix) |
| Aerodiol |
| AJ-64042 |
| AKOS015896570 |
| Alora |
| alpha-estradiol (obsolete) |
| Altrad |
| Amnestrogen |
| AN-6628 |
| AOB5963 |
| Aquadiol |
| AS-13729 |
| B-Estradiol |
| B8B5AEF5-4957-49EB-A14F-444A8212C482 |
| Bardiol |
| BC200811 |
| BCP08579 |
| BDBM17292 |
| Benzogynestry |
| beta-Estradiol |
| beta-Estradiol, >=98% |
| beta-Estradiol, 98% |
| beta-Estradiol, analytical standard |
| beta-Estradiol, BioReagent, powder, suitable for cell culture |
| beta-Estradiol, powder, gamma-irradiated, suitable for cell culture |
| BIDD:ER0125 |
| BIDD:PXR0065 |
| Bio-E-Gel |
| Bio1_000403 |
| Bio1_000892 |
| Bio1_001381 |
| Bio2_000363 |
| Bio2_000843 |
| bmse000642 |
| BPBio1_000532 |
| BRD-K18910433-001-04-4 |
| BRD-K18910433-001-43-2 |
| BSPBio_000482 |
| BSPBio_001065 |
| C00951 |
| C18H24O2 |
| CAS-50-28-2 |
| CCG-100808 |
| CCRIS 280 |
| CHEBI:16469 |
| CHEMBL135 |
| cis-Estradiol |
| cis-Oestradiol |
| Climaderm |
| Climara |
| Climara (TN) |
| Climara Forte |
| Climara Pro (Salt/Mix) |
| Climara, Menostar |
| cMAP_000005 |
| CMC_11154 |
| Combipatch (Salt/Mix) |
| component of Menrium |
| Compudose |
| Compudose 200 |
| Compudose 365 |
| Corpagen |
| CPD000059126 |
| CS-1938 |
| D-3,17-beta-Estradiol |
| D-3,17-beta-Oestradiol |
| D-3,17.beta.-Estradiol |
| D-3,17.beta.-Oestradiol |
| D-3,17beta-Estradiol |
| D-3,17beta-Oestradiol |
| D-Estradiol |
| D-Oestradiol |
| D00105 |
| DB00783 |
| delta-Estradiol |
| delta-Oestradiol |
| Dermestril |
| Destradiol |
| dihydro-Theelin |
| Dihydrofollicular hormone |
| Dihydrofolliculin |
| Dihydromenformon |
| Dihydrotheelin |
| Dihydroxyesterin |
| Dihydroxyestrin |
| Dihydroxyoestrin |
| Dimenformon |
| Dimenformon prolongatum |
| Diogyn |
| Diogynets |
| Divigel |
| Divigel (TN) |
| DSSTox_CID_573 |
| DSSTox_GSID_20573 |
| DSSTox_RID_75666 |
| DTXSID0020573 |
| E 2 |
| E 8875 |
| E(sub 2) |
| E0025 |
| EC 200-023-8 |
| EINECS 200-023-8 |
| Elestrim |
| Elestrin |
| Encore |
| Epiestriol 50 |
| Epitope ID:136018 |
| Esclim |
| Estasorb |
| Estra-1,3,5(10)-triene -3,17beta-diol |
| Estra-1,3,5(10)-triene-3,17-beta-diol |
| Estra-1,3,5(10)-triene-3,17-diol (17.beta.)- |
| Estra-1,3,5(10)-triene-3,17-diol (17beta)- |
| Estra-1,3,5(10)-triene-3,17-diol (17beta)-, homopolymer |
| Estra-1,3,5(10)-triene-3,17-diol, (17beta)- |
| Estra-1,3,5(10)-triene-3,17-diol(17b)- |
| Estra-1,3,5(10)-triene-3,17.beta.-diol |
| Estra-1,3,5(10)-triene-3,17b-diol |
| Estra-1,3,5(10)-triene-3,17beta-diol |
| Estra-1,5(10)-triene-3,17-diol (17.beta.)- |
| Estra-1,5(10)-triene-3,17-diol, (17.beta.)- |
| Estra-1,5(10)-triene-3,17.beta.-diol |
| estra-1(10),2,4-triene-3,17-diol, (17beta)- |
| Estrace |
| Estrace (TN) |
| Estraderm |
| Estraderm (TN) |
| Estraderm MX |
| Estraderm TTS |
| Estraderm TTS 100 |
| Estraderm TTS 50 |
| Estradiol (JAN/USP/INN) |
| Estradiol [USAN:INN] |
| Estradiol [USP:INN:BAN] |
| Estradiol complex |
| ESTRADIOL HEMIHYDRATE |
| Estradiol-17 alpha |
| Estradiol-17 beta |
| Estradiol-17-beta |
| Estradiol-17.beta. |
| estradiol-17beta |
| Estradiol-3,17beta |
| Estradiol, .beta.- |
| Estradiol, meets USP testing specifications |
| Estradiol, Pharmaceutical Secondary Standard; Certified Reference Material |
| Estradiol, United States Pharmacopeia (USP) Reference Standard |
| Estradiolo |
| Estradiolo [DCIT] |
| Estradiolum |
| Estradiolum [INN] |
| Estradot |
| Estraldine |
| Estrapak 50 |
| Estrasorb |
| Estrasorb (TN) |
| Estreva |
| Estrifam |
| Estring |
| Estring (TN) |
| Estring vaginal ring |
| Estroclim |
| Estroclim 50 |
| Estrodiolum |
| Estrodiolum [INN-Latin] |
| Estrofem 2 |
| Estrofem Forte |
| Estrogel |
| Estrogel (TN) |
| Estrogel HBF |
| Estrogens, esterified |
| Estropause |
| Estrovite |
| EU-0100503 |
| Evamist |
| Evorel |
| Extrasorb |
| Fem7 |
| Femanest |
| Femestral |
| Femestrol |
| Femogen |
| Fempatch |
| Femtran |
| Follicyclin |
| Gelestra |
| Ginedisc |
| Ginosedol |
| GTPL1012 |
| GTPL1013 |
| Gynergon |
| Gynestrel |
| Gynodiol |
| Gynoestryl |
| GynPolar |
| HMS1362E07 |
| HMS1569I04 |
| HMS1792E07 |
| HMS1990E07 |
| HMS2051C17 |
| HMS2090E18 |
| HMS2096I04 |
| HMS2236H04 |
| HMS3261F07 |
| HMS3403E07 |
| HMS3713I04 |
| HSDB 3589 |
| HY-B0141 |
| I06-2405 |
| IDI1_002118 |
| Innofem |
| Innofem (TN) |
| J10189 |
| KBio2_000405 |
| KBio2_002269 |
| KBio2_002973 |
| KBio2_004837 |
| KBio2_005541 |
| KBio2_007405 |
| KBio3_000769 |
| KBio3_000770 |
| KBio3_002749 |
| KBioGR_000405 |
| KBioGR_002269 |
| KBioSS_000405 |
| KBioSS_002270 |
| Lamdiol |
| LMST02010001 |
| Lopac0_000503 |
| LP00503 |
| LS-137 |
| Macrodiol |
| Macrol |
| Menest |
| Menorest |
| MFCD00003693 |
| Microdiol |
| Minivelle |
| MLS000069494 |
| MLS000758312 |
| MLS001076331 |
| MLS001424022 |
| MolPort-001-794-632 |
| NC00058 |
| NCGC00091544-00 |
| NCGC00091544-01 |
| NCGC00091544-02 |
| NCGC00091544-04 |
| NCGC00091544-05 |
| NCGC00091544-06 |
| NCGC00091544-07 |
| NCGC00091544-09 |
| NCGC00091544-10 |
| NCGC00091544-11 |
| NCGC00091544-12 |
| NCGC00091544-13 |
| NCGC00091544-14 |
| NCGC00091544-15 |
| NCGC00091544-16 |
| NCGC00179321-01 |
| NCGC00179321-02 |
| NCGC00254177-01 |
| NCGC00259606-01 |
| NCGC00261188-01 |
| Nordicol |
| NSC-9895 |
| NSC9895 |
| Oesclim |
| Oestergon |
| Oestra-1,3,5(10)-triene-3,17-beta-diol |
| Oestra-1,3,5(10)-triene-3,17.beta.-diol |
| Oestra-1,3,5(10)-triene-3,17b-diol |
| Oestra-1,3,5(10)-triene-3,17beta-diol |
| Oestra-1,5(10)-triene-3,17.beta.-diol |
| Oestradiol |
| Oestradiol Berco |
| Oestradiol R |
| Oestradiol-17-beta |
| Oestradiol-17.beta. |
| Oestradiol-17beta |
| Oestradiol-17beta and esters |
| Oestradiol-17beta and esters [Steroidal oestrogens] |
| Oestradiolum |
| oestrodiol |
| Oestrogel |
| Oestroglandol |
| Oestrogynal |
| Opera_ID_1688 |
| Ovahormon |
| Ovasterol |
| Ovastevol |
| Ovociclina |
| Ovocyclin |
| Ovocycline |
| Ovocylin |
| Perlatanol |
| Polyestradiol |
| Prestwick_207 |
| Prestwick0_000441 |
| Prestwick1_000441 |
| Prestwick2_000441 |
| Prestwick3_000441 |
| Primofol |
| Profoliol |
| Profoliol B |
| progynon |
| Progynon DH |
| Progynon-DH |
| Q-201503 |
| S-21400 |
| s1709 |
| Sandrena 1 |
| Sandrena Gel |
| SC-25771 |
| SCHEMBL8049 |
| Sisare Gel |
| SK-Estrogens |
| SL-1100 |
| SMP1_000121 |
| SMR000059126 |
| SPBio_002421 |
| Spectrum5_002055 |
| SR-01000075866 |
| SR-01000075866-1 |
| SR-01000075866-4 |
| SR-01000721892 |
| SR-01000721892-3 |
| Syndiol |
| Systen |
| Theelin, dihydro- |
| Tox21_111148 |
| Tox21_202057 |
| Tox21_300288 |
| Tox21_500503 |
| Tradelia |
| Trial SAT |
| Trocosone |
| TX-004HR |
| UNII-125DP6010H |
| UNII-4TI98Z838E |
| Vagifem |
| Vagifem (TN) |
| Vivelle |
| Vivelle (TN) |
| VIVELLE-DOT |
| VOXZDWNPVJITMN-ZBRFXRBCSA-N |
| WLN: L E5 B666TTT&J E1 FQ OQ |
| Yuvvexy |
| Z-4415 |
| Z1847670481 |
| Zerella |
| Zesteem |
| Zesteen |
| ZINC13520815 |
| Zumenon |
Generic filers with tentative approvals for ESTRADIOL
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | ESTRADIOL AND NORGESTIMATE | estradiol; norgestimate | TABLET;ORAL | 076812-001 | Apr 29, 2005 | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Mylan Labs Ltd | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 207261-002 | Feb 10, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Watson Labs | ESTRADIOL CYPIONATE | estradiol cypionate | INJECTABLE;INJECTION | 085620-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 |
|---|---|---|---|---|---|---|---|
| Novartis | ESTRADERM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 019081-003 | Sep 10, 1986 | ➤ Sign Up | ➤ Sign Up |
| Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-002 | Oct 29, 2012 | ➤ Sign Up | ➤ Sign Up |
| Novartis | VIVELLE-DOT | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020538-006 | Jan 8, 1999 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for estradiol
Supplementary Protection Certificates for estradiol
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 122015000093 | Germany | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 0285237 | 95C0008 | Belgium | ➤ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107 |
| 0398460 | SPC/GB04/032 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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