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OmniRx › Tools › Generic competition check › Levothyroxine Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Levothyroxine Sodium, and who makes it?

Levothyroxine Sodium appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them. 3 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 1.8 and 14 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.
Levothyroxine Sodium5 dosage-form groups in the Orange Book
11generic makers listed
  1. Levothyroxine Sodium appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them.
  2. 3 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.
  3. Where both are dated, the first generic approval came between 1.8 and 14 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: Levo-T, Levolet, Levoxyl and Synthroid. 7 generic makers with 84 generic products listed as marketed; the first generic approval is dated 5 June 2002.

20002005201020152020202520302035204007brand 2000Mylan Pharmaceuticals Inc, first approval 5 June 2002Lupin Inc, first approval 18 January 2019Accord Healthcare Inc, first approval 19 October 2020Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc, first approval 10 May 2022Macleods Pharmaceuticals Ltd, first approval 21 December 2022Ascent Pharmaceuticals Inc, first approval 18 January 2023Alembic Pharmaceuticals Ltd, first approval 20 May 2026data datePatent 10406108 listed to expire 23 March 2038Patent 10231931 listed to expire 23 March 2038
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Pharmaceuticals Inc5 June 200212
Lupin Inc18 January 201912
Accord Healthcare Inc19 October 202012
Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc10 May 202212
Macleods Pharmaceuticals Ltd21 December 202212
Ascent Pharmaceuticals Inc18 January 202312
Alembic Pharmaceuticals Ltd20 May 202612

Patents and exclusivities still listed

  • 23 March 2038Patent 10406108 drug product
  • 23 March 2038Patent 10231931 drug product

Capsule, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Tirosint. No generic is listed as marketed (9 generic products listed as discontinued).

20052010201520202025203020352040204501brand 2006data datePatent 12564565 listed to expire 26 September 2044
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 26 September 2044Patent 12564565 drug product

Powder, Intravenous

Four or more generic makers listed

Brand listed as marketed: Levothyroxine Sodium. 4 generic makers with 10 generic products listed as marketed; the first generic approval is dated 7 December 2015.

20102015202020252030203504brand 2011Maia Pharmaceuticals Inc, first approval 21 December 2018Zydus Pharmaceuticals Usa Inc, first approval 24 March 2023Xiromed Pharma Espana Sl, first approval 29 November 2024Onesource Specialty Pte Ltd, first approval 5 March 2025data datePatent 9168239 listed to expire 29 August 2032Patent 9168238 listed to expire 29 August 2032Patent 9006289 listed to expire 3 October 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Maia Pharmaceuticals Inc21 December 20183
Zydus Pharmaceuticals Usa Inc24 March 20233
Xiromed Pharma Espana Sl29 November 20241
Onesource Specialty Pte Ltd5 March 20253

Patents and exclusivities still listed

  • 29 August 2032Patent 9168239 drug product
  • 29 August 2032Patent 9168238 drug product
  • 3 October 2032Patent 9006289 drug product

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Thyquidity and Tirosint-Sol. No generic is listed as marketed.

201520202025203020352040204501brand 2016data datePatent 9050307 listed to expire 6 August 2031Patent 11096913 listed to expire 28 February 2037Patent 10537538 listed to expire 28 February 2037Patent 11241382 listed to expire 17 September 2039Patent 12564565 listed to expire 26 September 2044
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 6 August 2031Patent 9050307 drug product
  • 28 February 2037Patent 11096913 drug product
  • 28 February 2037Patent 10537538 drug product
  • 17 September 2039Patent 11241382
  • 26 September 2044Patent 12564565 drug product

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Levothyroxine Sodium. No generic is listed as marketed.

20152020202520302035204001brand 2019data datePatent 9782376 listed to expire 1 December 2036Patent 11135190 listed to expire 1 December 2036Patent 12636270 listed to expire 1 December 2036Patent 10398669 listed to expire 1 December 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 December 2036Patent 9782376 drug product
  • 1 December 2036Patent 11135190 drug product
  • 1 December 2036Patent 12636270 drug product
  • 1 December 2036Patent 10398669 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.