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OmniRx › Tools › Generic competition check › Loteprednol Etabonate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Loteprednol Etabonate, and who makes it?

Loteprednol Etabonate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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 8.4 and 21.1 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.
Loteprednol Etabonate3 dosage-form groups in the Orange Book
5generic makers listed
  1. Loteprednol Etabonate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 5 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 8.4 and 21.1 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.

Suspension/Drops, Ophthalmic

Four or more generic makers listed

Brand listed as marketed: Alrex, Eysuvis, Inveltys and Lotemax. 5 generic makers with 9 generic products listed as marketed; the first generic approval is dated 17 April 2019.

19952000200520102015202020252030203505brand 1998Sentiss Ag, first approval 17 April 2019Sun Pharmaceutical Industries Ltd, first approval 26 February 2021Lupin Ltd, first approval 26 December 2023Padagis Us Llc, first approval 10 July 2024Amneal Eu Ltd, first approval 13 December 2024data datePatent 11219596 listed to expire 3 May 2033Patent 11596599 listed to expire 3 May 2033Patent 10857096 listed to expire 3 May 2033Patent 10945948 listed to expire 3 May 2033Patent 10940108 listed to expire 3 May 2033Patent 9532955 listed to expire 3 May 2033Patent 9737491 listed to expire 3 May 2033Patent 9056057 listed to expire 3 May 2033Patent 9827191 listed to expire 3 May 2033Patent 10058511 listed to expire 3 May 2033Patent 10993908 listed to expire 3 May 2033Patent 12115246 listed to expire 3 May 2033Patent 11642317 listed to expire 3 May 2033Patent 10688045 listed to expire 3 May 2033Patent 10646436 listed to expire 3 May 2033Patent 9393213 listed to expire 3 May 2033Patent 11872318 listed to expire 3 May 2033Patent 11219597 listed to expire 3 May 2033Patent 10864219 listed to expire 3 May 2033Patent 10646437 listed to expire 3 May 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sentiss Ag17 April 20192
Sun Pharmaceutical Industries Ltd26 February 20211
Lupin Ltd26 December 20232
Padagis Us Llc10 July 20242
Amneal Eu Ltd13 December 20242

Patents and exclusivities still listed

  • 3 May 2033Patent 11219596
  • 3 May 2033Patent 11596599
  • 3 May 2033Patent 10857096
  • 3 May 2033Patent 10945948
  • 3 May 2033Patent 10940108
  • 3 May 2033Patent 9532955
  • 3 May 2033Patent 9737491
  • 3 May 2033Patent 9056057 drug product

12 more patents are listed.

Gel, Ophthalmic

One to three generic makers listed

Brand listed as marketed: Lotemax and Lotemax Sm. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 10 February 2021.

201020152020202520302035204002brand 2012Sentiss Ag, first approval 10 February 2021Lupin Ltd, first approval 30 June 2025data datePatent 11534395 listed to expire 26 January 2036Patent 12589069 listed to expire 26 January 2036Patent 10596107 listed to expire 23 December 2036
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sentiss Ag10 February 20211
Lupin Ltd30 June 20251

Patents and exclusivities still listed

  • 26 January 2036Patent 11534395 drug product
  • 26 January 2036Patent 12589069 drug product
  • 23 December 2036Patent 10596107 drug product

Ointment, Ophthalmic

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2011data 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.

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.