Generic competition · all medicines · read 12 November 2026
Is there a generic of Levonorgestrel, and who makes it?
Levonorgestrel appears in 3 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 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.
- Levonorgestrel appears in 3 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 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: Plan B One-Step. 12 generic makers with 13 generic products listed as marketed; the first generic approval is dated 24 June 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Novel Laboratories Inc | 22 February 2013 | 1 |
| Lupin Ltd | 19 June 2014 | 1 |
| Perrigo R And D Co | 20 August 2014 | 1 |
| Sun Pharmaceutical Industries Ltd | 11 September 2014 | 1 |
| Xiromed Llc | 31 October 2014 | 1 |
| Naari Pte Ltd | 29 May 2015 | 2 |
| Aurobindo Pharma Ltd | 8 December 2015 | 1 |
| Novast Laboratories Ltd | 11 March 2016 | 1 |
| Glenmark Pharmaceuticals Ltd | 25 March 2016 | 1 |
| Laboratoire Hra Pharma | 3 July 2018 | 1 |
| Xiromed Pharma Espana Sl | 18 September 2018 | 1 |
| Annora Pharma Private Ltd | 30 September 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Implant, Implantation
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.
System, Intrauterine
Brand listed, no generic listed as marketed
Brand listed as marketed: Kyleena, Liletta, Mirena and Skyla. No generic is listed as marketed.
Patents and exclusivities still listed
- 7 February 2027Patent 11628088 drug product
- 14 September 2029Patent 11850182 drug product
- 16 September 2029Patent 10561524
- 6 October 2033Patent 12004992 drug substance
- 24 October 2033Patent 11090186
- 22 March 2034Patent 10028858 drug product
- 7 September 2040Patent 11571328 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.