Generic competition · all medicines · read 12 November 2026
Is there a generic of Ethinyl Estradiol; Norethindrone Acetate, and who makes it?
Ethinyl Estradiol; Norethindrone Acetate appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them. 1 group has 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 4.3 and 9.9 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.
- Ethinyl Estradiol; Norethindrone Acetate appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them.
- 1 group has 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 4.3 and 9.9 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.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Lo Loestrin Fe. 8 generic makers with 17 generic products listed as marketed; the first generic approval is dated 1 September 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Barr Laboratories Inc | 6 November 2009 | 1 |
| Barr Laboratories Llc (An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc) | 1 December 2014 | 1 |
| Novast Laboratories Ltd | 18 February 2015 | 3 |
| Glenmark Pharmaceuticals Ltd | 2 April 2015 | 4 |
| Lupin Ltd | 28 October 2015 | 4 |
| Aurobindo Pharma Ltd | 15 June 2017 | 1 |
| Xiromed Pharma Espana Sl | 16 July 2018 | 1 |
| Teva Pharmaceuticals Usa Inc | 7 April 2020 | 2 |
Patents and exclusivities still listed
- 2 February 2029Patent 7704984
Tablet, Oral-28
Four or more generic makers listed
Every brand product here is listed as discontinued. 7 generic makers with 15 generic products listed as marketed; the first generic approval is dated 5 February 2001.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Barr Laboratories Inc | 18 September 2003 | 3 |
| Novast Laboratories Ltd | 23 August 2013 | 3 |
| Xiromed Llc | 14 November 2013 | 3 |
| Lupin Ltd | 18 November 2015 | 2 |
| Aurobindo Pharma Ltd | 15 June 2017 | 2 |
| Glenmark Pharmaceuticals Ltd | 21 November 2017 | 1 |
| Glenmark Specialty Sa | 5 June 2018 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral-21
Four or more generic makers listed
Every brand product here is listed as discontinued. 7 generic makers with 10 generic products listed as marketed; the first generic approval is dated 30 May 2003.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Barr Laboratories Inc | 30 May 2003 | 1 |
| Barr Laboratories Llc (An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc) | 30 May 2003 | 1 |
| Xiromed Llc | 6 November 2013 | 2 |
| Novast Laboratories Ltd | 4 December 2013 | 2 |
| Glenmark Pharmaceuticals Ltd | 20 January 2016 | 1 |
| Aurobindo Pharma Ltd | 16 June 2017 | 2 |
| Glenmark Specialty Sa | 5 June 2018 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Oral
One to three generic makers listed
Brand listed as marketed: Taytulla. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 9 November 2020.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Xiromed Pharma Espana Sl | 9 November 2020 | 1 |
| Wilshire Pharmaceuticals Inc | 18 December 2020 | 1 |
| Glenmark Pharmaceuticals Ltd | 27 July 2022 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Chewable, Tablet, Oral
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.
Tablet, Orally Disintegrating, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Femlyv. No generic is listed as marketed.
Patents and exclusivities still listed
- 22 July 2027Exclusivity NP Femlyv
- 24 June 2041Patent 12178824 drug product
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.