Generic competition · all medicines · read 12 November 2026
Is there a generic of Estradiol, and who makes it?
Estradiol appears in 11 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 generic makers listed as marketed across them. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 5.2 and 28.3 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Estradiol appears in 11 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 17 generic makers listed as marketed across them.
- 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 5.2 and 28.3 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Film, Extended Release, Transdermal
One to three generic makers listed
Brand listed as marketed: Climara and Minivelle. 3 generic makers with 22 generic products listed as marketed; the first generic approval is dated 24 February 2000.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Technologies Inc | 24 February 2000 | 11 |
| Amneal Pharmaceuticals Llc | 28 September 2020 | 5 |
| Zydus Pharmaceuticals Usa Inc | 29 March 2023 | 6 |
Patents and exclusivities still listed
- 10 July 2028Patent 9730900 drug product
- 10 July 2028Patent 9833419 drug product
- 10 July 2028Patent 9724310 drug substance
- 4 July 2030Patent 8231906 drug substance
System, Transdermal
One to three generic makers listed
Brand listed as marketed: Menostar and Vivelle-Dot. 3 generic makers with 16 generic products listed as marketed; the first generic approval is dated 19 December 2014.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Technologies Inc | 19 December 2014 | 5 |
| Amneal Pharmaceuticals Llc | 4 February 2019 | 5 |
| Zydus Pharmaceuticals Usa Inc | 1 December 2022 | 6 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Transdermal
Four or more generic makers listed
Brand listed as marketed: Divigel. 6 generic makers with 28 generic products listed as marketed; the first generic approval is dated 10 August 2022.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Xiromed Pharma Espana Sl | 10 August 2022 | 3 |
| Novitium Pharma Llc | 24 August 2023 | 5 |
| Padagis Israel Pharmaceuticals Ltd | 14 November 2023 | 5 |
| Amneal Pharmaceuticals Llc | 12 July 2024 | 5 |
| Amvika Pharma Llc | 12 July 2024 | 5 |
| Encube Ethicals Private Ltd | 5 March 2025 | 5 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral
Generics listed, no brand listed
No brand application is listed. 3 generic makers with 9 generic products listed as marketed; the first generic approval is dated 30 June 1993.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Barr Laboratories Inc | 22 October 1997 | 3 |
| Epic Pharma Llc | 29 December 1998 | 3 |
| Novitium Pharma Llc | 6 September 2023 | 3 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Cream, Vaginal
Generics listed, no brand listed
No brand application is listed. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 31 January 1984.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Abbvie Inc | 31 January 1984 | 1 |
| Mylan Pharmaceuticals Inc | 29 December 2017 | 1 |
| Padagis Israel Pharmaceuticals Ltd | 22 January 2018 | 1 |
| Encube Ethicals Private Ltd | 5 March 2018 | 1 |
| Teva Pharmaceuticals Usa Inc | 30 March 2018 | 1 |
| Prasco Llc Dba Prasco Laboratories | 15 July 2021 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Gel, Metered, Transdermal
One to three generic makers listed
Brand listed as marketed: Elestrin and Estrogel. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 22 April 2024.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Solaris Pharma Corp | 22 April 2024 | 1 |
| Novitium Pharma Llc | 23 October 2024 | 1 |
| Encube Ethicals Private Ltd | 11 May 2026 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Vaginal
Four or more generic makers listed
Brand listed as marketed: Vagifem. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 29 May 2015.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Amneal Pharmaceuticals | 29 May 2015 | 1 |
| Teva Pharmaceuticals Usa | 21 July 2017 | 1 |
| Glenmark Pharmaceuticals Ltd | 14 September 2018 | 1 |
| Aurobindo Pharma Ltd | 2 August 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Insert, Vaginal
One to three generic makers listed
Brand listed as marketed: Imvexxy. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 8 December 2025.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 8 December 2025 | 2 |
Patents and exclusivities still listed
- 21 November 2032Patent 10258630
- 21 November 2032Patent 10398708
- 21 November 2032Patent 10471072
- 21 November 2032Patent 10537581 drug product
- 21 November 2032Patent 11246875
- 21 November 2032Patent 11241445
- 21 November 2032Patent 10668082
- 21 November 2032Patent 10568891
12 more patents are listed.
Gel, Topical
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Insert, Extended Release, Vaginal
Brand listed, no generic listed as marketed
Brand listed as marketed: Estring. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Spray, Transdermal
Brand listed, no generic listed as marketed
Brand listed as marketed: Evamist. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.