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OmniRx › Tools › Generic competition check › Raltegravir Potassium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Raltegravir Potassium, and who makes it?

Raltegravir Potassium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them. 2 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 17.2 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.
Raltegravir Potassium3 dosage-form groups in the Orange Book
2generic makers listed
  1. Raltegravir Potassium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them.
  2. 2 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 17.2 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

One to three generic makers listed

Brand listed as marketed: Isentress and Isentress Hd. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 19 December 2024.

200520102015202020252030203502brand 2007Hetero Labs Ltd Unit Iii, first approval 19 December 2024Lupin Ltd, first approval 6 May 2025data datePatent 8852632 listed to expire 28 January 2028Patent 7754731 listed to expire 11 March 2029Patent 7754731*PED listed to expire 11 September 2029Patent 8771733 listed to expire 2 June 2030Patent 9649311 listed to expire 21 October 2030Patent 9649311*PED listed to expire 21 April 2031Patent 10772888 listed to expire 30 March 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hetero Labs Ltd Unit Iii19 December 20241
Lupin Ltd6 May 20251

Patents and exclusivities still listed

  • 28 January 2028Patent 8852632 drug substance
  • 11 March 2029Patent 7754731 drug substance
  • 11 September 2029Patent 7754731*PED
  • 2 June 2030Patent 8771733 drug substance
  • 21 October 2030Patent 9649311 drug product
  • 21 April 2031Patent 9649311*PED
  • 30 March 2032Patent 10772888

Tablet, Chewable, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2011data datePatent 7754731 listed to expire 11 March 2029Patent 7754731*PED listed to expire 11 September 2029Patent 8771733 listed to expire 2 June 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 11 March 2029Patent 7754731 drug substance
  • 11 September 2029Patent 7754731*PED
  • 2 June 2030Patent 8771733 drug substance

Powder, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2013data datePatent 7754731 listed to expire 11 March 2029Patent 7754731*PED listed to expire 11 September 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 11 March 2029Patent 7754731 drug substance
  • 11 September 2029Patent 7754731*PED

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.