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OmniRx › Tools › Generic competition check › Darunavir

Generic competition · all medicines · read 12 November 2026

Is there a generic of Darunavir, and who makes it?

Darunavir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 11.4 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.
Darunavir2 dosage-form groups in the Orange Book
10generic makers listed
  1. Darunavir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 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 11.4 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: Prezista. 10 generic makers with 23 generic products listed as marketed; the first generic approval is dated 21 November 2017.

200520102015202020252030010brand 2006Lupin Ltd, first approval 29 September 2022Hetero Labs Ltd Unit Iii, first approval 14 September 2023Aurobindo Pharma Ltd, first approval 28 November 2023Cipla Ltd, first approval 28 November 2023Dr Reddys Laboratories Ltd, first approval 28 November 2023Msn Laboratories Private Ltd, first approval 28 November 2023Amneal Eu Ltd, first approval 8 December 2023Zydus Lifesciences Ltd, first approval 13 December 2023Annora Pharma Private Ltd, first approval 21 January 2025Mylan Pharmaceuticals Inc, first approval 22 July 2025data datePatent 7700645 listed to expire 26 December 2026Patent 7700645*PED listed to expire 26 June 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Lupin Ltd29 September 20222
Hetero Labs Ltd Unit Iii14 September 20232
Aurobindo Pharma Ltd28 November 20232
Cipla Ltd28 November 20232
Dr Reddys Laboratories Ltd28 November 20232
Msn Laboratories Private Ltd28 November 20232
Amneal Eu Ltd8 December 20232
Zydus Lifesciences Ltd13 December 20232
Annora Pharma Private Ltd21 January 20252
Mylan Pharmaceuticals Inc22 July 20255

Patents and exclusivities still listed

  • 26 December 2026Patent 7700645 drug substance
  • 26 June 2027Patent 7700645*PED

Suspension, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2011data datePatent 7700645 listed to expire 26 December 2026Patent 7700645*PED listed to expire 26 June 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 26 December 2026Patent 7700645 drug substance
  • 26 June 2027Patent 7700645*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.