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OmniRx › Tools › Generic competition check › Ethinyl Estradiol; Levonorgestrel

Generic competition · all medicines · read 12 November 2026

Is there a generic of Ethinyl Estradiol; Levonorgestrel, and who makes it?

Ethinyl Estradiol; Levonorgestrel appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 8 and 11.6 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.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Ethinyl Estradiol; Levonorgestrel4 dosage-form groups in the Orange Book
12generic makers listed
  1. Ethinyl Estradiol; Levonorgestrel appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 generic makers listed as marketed across them.
  2. 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.
  3. Where both are dated, the first generic approval came between 8 and 11.6 years after the first brand approval.
  4. 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: Balcoltra, Loseasonique, Quartette and Seasonale. 9 generic makers with 25 generic products listed as marketed; the first generic approval is dated 6 September 2006.

1995200020052010201520202025203009brand 1998Watson Laboratories Inc, first approval 6 September 2006Xiromed Pharma Espana Sl, first approval 27 September 2010Dr Reddys Laboratories Sa, first approval 31 May 2011Lupin Ltd, first approval 26 October 2011Novast Laboratories Ltd, first approval 15 September 2014Glenmark Pharmaceuticals Ltd, first approval 23 February 2015Xiromed Llc, first approval 21 April 2015Naari Pte Ltd, first approval 13 November 2015Aurobindo Pharma Ltd, first approval 7 April 2017data datePatent 7838042 listed to expire 1 June 2027Patent 7855190 listed to expire 5 December 2028Patent 8415332 listed to expire 11 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Watson Laboratories Inc6 September 20062
Xiromed Pharma Espana Sl27 September 20104
Dr Reddys Laboratories Sa31 May 20111
Lupin Ltd26 October 20114
Novast Laboratories Ltd15 September 20142
Glenmark Pharmaceuticals Ltd23 February 20153
Xiromed Llc21 April 20154
Naari Pte Ltd13 November 20152
Aurobindo Pharma Ltd7 April 20173

Patents and exclusivities still listed

  • 1 June 2027Patent 7838042 drug substance
  • 5 December 2028Patent 7855190
  • 11 March 2029Patent 8415332 drug product

Tablet, Oral-28

Four or more generic makers listed

Every brand product here is listed as discontinued. 11 generic makers with 23 generic products listed as marketed; the first generic approval is dated 13 December 1993.

19801985199019952000200520102015202020252030011brand 1982Dr Reddys Laboratories Sa, first approval 13 December 1993Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc, first approval 30 April 2001Barr Laboratories Inc, first approval 20 March 2002Xiromed Pharma Espana Sl, first approval 3 August 2010Novast Laboratories Ltd, first approval 29 December 2010Glenmark Pharmaceuticals Ltd, first approval 29 February 2012Lupin Ltd, first approval 17 October 2012Xiromed Llc, first approval 21 December 2012Aurobindo Pharma Ltd, first approval 23 September 2016Naari Pte Ltd, first approval 17 August 2020Hetero Labs Ltd, first approval 13 February 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Dr Reddys Laboratories Sa13 December 19934
Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc30 April 20012
Barr Laboratories Inc20 March 20022
Xiromed Pharma Espana Sl3 August 20102
Novast Laboratories Ltd29 December 20102
Glenmark Pharmaceuticals Ltd29 February 20121
Lupin Ltd17 October 20123
Xiromed Llc21 December 20122
Aurobindo Pharma Ltd23 September 20162
Naari Pte Ltd17 August 20202
Hetero Labs Ltd13 February 20231

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Oral-21

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed (7 generic products listed as discontinued).

1980198519901995200020052010201520202025203001brand 1982data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

System, Transdermal

Brand listed, no generic listed as marketed

Brand listed as marketed: Twirla. No generic is listed as marketed.

20202025203001brand 2020data datePatent 8747888 listed to expire 10 July 2028Patent 9050348 listed to expire 10 July 2028Patent 8246978 listed to expire 26 August 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 10 July 2028Patent 8747888 drug product
  • 10 July 2028Patent 9050348 drug product
  • 26 August 2028Patent 8246978 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.