FDA Orange Book · active-ingredient family
Estradiol
Estradiol is approved as 17 brand and 41 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IMVEXXY · NDA 208564
17
Brand (NDA)
41
Generics (ANDA)
24
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, film, extended release, gel, gel, metered, insert, insert, extended release, spray, system, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMVEXXYRLD×2 | MAYNE PHARMA | NDA 208564 | AB | May 29, 2018 | |
| MINIVELLERLD×5 | NOVEN | NDA 203752 | AB3 | Sep 23, 2014 | |
| VAGIFEMRLD×2 | NOVO NORDISK INC | NDA 020908 | AB | Nov 25, 2009 | |
| EVAMISTRLD | PADAGIS US | NDA 022014 | — | Jul 27, 2007 | |
| DIVIGELRLD×5 | VERTICAL PHARMS | NDA 022038 | AB | Jun 04, 2007 | |
| ELESTRINRLD | VIATRIS | NDA 021813 | — | Dec 15, 2006 | |
| MENOSTARRLD | BAYER HLTHCARE | NDA 021674 | AB | Jun 08, 2004 | |
| ESTROGELRLD×2 | ASCEND THERAPS US | NDA 021166 | AB | Feb 09, 2004 | |
| VIVELLE-DOTRLD×5 | SANDOZ | NDA 020538 | AB1 | May 03, 2002 | |
| CLIMARARLD×6 | BAYER HLTHCARE | NDA 020375 | AB2 | Mar 05, 1999 | |
| ESTRINGRLD | PFIZER | NDA 020472 | — | Apr 26, 1996 | |
| ESTRADERMRLD×2 | NOVARTIS | NDA 019081 | — | Sep 10, 1986 | |
| ALORA×4 | ABBVIE | NDA 020655 | — | Apr 05, 2002 | |
| VIVELLE×5 | SANDOZ | NDA 020323 | — | Aug 16, 2000 | |
| ESTRADIOL×3 | ORTHO MCNEIL PHARM | NDA 021048 | — | Sep 20, 1999 | |
| ESCLIM×5 | WOMEN FIRST HLTHCARE | NDA 020847 | — | Aug 04, 1998 | |
| FEMPATCH | PARKE DAVIS | NDA 020417 | — | Dec 03, 1996 |
Generic (ANDA) products (41)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESTRADIOL | ENCUBE | ANDA 218214 | AB | May 11, 2026 | |
| ESTRADIOL | PADAGIS US | ANDA 215096 | AB | Feb 02, 2026 | |
| ESTRADIOL×2 | TEVA PHARMS USA INC | ANDA 214137 | AB | Dec 08, 2025 | |
| ESTRADIOL×5 | ENCUBE | ANDA 218507 | AB | Mar 05, 2025 | |
| ESTRADIOL | NOVITIUM PHARMA | ANDA 217882 | AB | Oct 23, 2024 | |
| ESTRADIOL | AUROBINDO PHARMA | ANDA 216550 | AB | Aug 02, 2024 | |
| ESTRADIOL×5 | AMNEAL | ANDA 216055 | AB | Jul 12, 2024 | |
| ESTRADIOL×5 | SOLARIS PHARMA CORP | ANDA 217863 | AB | Jul 12, 2024 | |
| ESTRADIOL | SOLARIS PHARMA CORP | ANDA 216160 | AB | Apr 22, 2024 | |
| ESTRADIOL×5 | PADAGIS ISRAEL | ANDA 216524 | AB | Nov 14, 2023 | |
| ESTRADIOL×3 | NOVITIUM PHARMA | ANDA 217334 | AB | Sep 06, 2023 | |
| ESTRADIOL×5 | NOVITIUM PHARMA | ANDA 217610 | AB | Aug 24, 2023 | |
| ESTRADIOL | ZYDUS PHARMS | ANDA 204379 | AB | Apr 17, 2023 | |
| ESTRADIOL×6 | ZYDUS PHARMS | ANDA 202985 | AB2 | Mar 29, 2023 | |
| ESTRADIOL×5 | ZYDUS PHARMS | ANDA 206241 | AB1 | Dec 01, 2022 | |
| ESTRADIOL×3 | XIROMED | ANDA 211783 | AB | Aug 10, 2022 | |
| ESTRADIOL | PRASCO | ANDA 212313 | AB | Jul 15, 2021 | |
| ESTRADIOL×5 | AMNEAL | ANDA 211396 | AB3 | Sep 28, 2020 | |
| ESTRADIOL×5 | AMNEAL | ANDA 211293 | AB1 | Feb 04, 2019 | |
| ESTRADIOL | GLENMARK PHARMS LTD | ANDA 210264 | AB | Sep 14, 2018 | |
| ESTRADIOL×5 | MYLAN TECHNOLOGIES | ANDA 206685 | AB3 | Aug 15, 2018 | |
| ESTRADIOL | TEVA PHARMS USA | ANDA 210488 | AB | Mar 30, 2018 | |
| ESTRADIOL | ENCUBE | ANDA 209767 | AB | Mar 05, 2018 | |
| ESTRADIOL | PADAGIS ISRAEL | ANDA 210194 | AB | Jan 22, 2018 | |
| ESTRADIOL | MYLAN | ANDA 208788 | AB | Dec 29, 2017 | |
| ESTRADIOL | TEVA PHARMS USA | ANDA 206388 | AB | Jul 21, 2017 | |
| ESTRADIOL | AMNEAL PHARMS | ANDA 205256 | AB | May 29, 2015 | |
| ESTRADIOL×5 | MYLAN TECHNOLOGIES | ANDA 201675 | AB1 | Dec 19, 2014 | |
| ESTRADIOL×6 | MYLAN TECHNOLOGIES | ANDA 075182 | AB2 | Jan 26, 2005 | |
| ESTRADIOL×3 | USL PHARMA | ANDA 040297 | — | Apr 17, 2002 | |
| INNOFEM×3 | NOVO NORDISK INC | ANDA 040312 | — | Nov 19, 1999 | |
| ESTRADIOL×3 | PHARMOBEDIENT | ANDA 040326 | — | Apr 21, 1999 | |
| ESTRADIOL×3 | EPIC PHARMA LLC | ANDA 040275 | AB | Dec 29, 1998 | |
| ESTRADIOL×3 | LANNETT CO INC | ANDA 040138 | — | Jan 30, 1998 | |
| GYNODIOL×4 | DURAMED PHARMS BARR | ANDA 040212 | — | Dec 29, 1997 | |
| ESTRADIOL×3 | BARR LABS INC | ANDA 040197 | AB | Oct 22, 1997 | |
| ESTRADIOL×3 | RUBICON RESEARCH | ANDA 040114 | — | Mar 14, 1996 | |
| ESTRACE | BRISTOL MYERS SQUIBB | ANDA 081295 | — | Jun 30, 1993 | |
| ESTRACERLD | ABBVIE | ANDA 086069 | AB | Jan 31, 1984 | |
| ESTRACERLD | BRISTOL MYERS SQUIBB | ANDA 084499 | — | Approved Prior to Jan 1, 1982 | |
| ESTRACERLD | BRISTOL MYERS SQUIBB | ANDA 084500 | — | Approved Prior to Jan 1, 1982 |
Listed patents (24)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9730900 | Jul 10, 2028 | in 2 yr 1 mo | ProductU-2086 |
| 9833419 | Jul 10, 2028 | in 2 yr 1 mo | Product |
| 9724310 | Jul 10, 2028 | in 2 yr 1 mo | SubstanceProduct |
| 8231906 | Jul 04, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 10258630 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 10398708 | Nov 21, 2032 | in 6 yr 6 mo | U-2317 |
| 10471072 | Nov 21, 2032 | in 6 yr 6 mo | U-2317 |
| 10537581 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2316 |
| 11246875 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 11241445 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 10668082 | Nov 21, 2032 | in 6 yr 6 mo | U-2317 |
| 10568891 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 9180091 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2317 |
| 10835487 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 10888516 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 11351182 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 11065197 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 9289382 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 10806697 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11123283 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11304959 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11116717 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11497709 | Nov 21, 2032 | in 6 yr 6 mo | U-2316 |
| 11266661 | Feb 02, 2034 | in 7 yr 9 mo | U-2316 |
Estradiol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
