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OmniRx › Tools › Generic competition check › Rilpivirine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Rilpivirine Hydrochloride, and who makes it?

Rilpivirine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 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 14.7 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.
Rilpivirine Hydrochloride2 dosage-form groups in the Orange Book
2generic makers listed
  1. Rilpivirine Hydrochloride appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 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 14.7 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: Edurant. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 29 January 2026.

2010201520202025203002brand 2011Somerset Therapeutics Llc, first approval 29 January 2026Laurus Labs Ltd, first approval 10 July 2026data dateExclusivity NPP to 15 March 2027Exclusivity PED to 15 September 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Somerset Therapeutics Llc29 January 20261
Laurus Labs Ltd10 July 20261

Patents and exclusivities still listed

  • 15 March 2027Exclusivity NPP Edurant
  • 15 September 2027Exclusivity PED Edurant

Tablet, For Suspension, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Edurant Ped. No generic is listed as marketed.

2020202520302035204001brand 2024data datePatent 11065198 listed to expire 23 October 2037Exclusivity NP to 15 March 2027Exclusivity PED to 15 September 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 March 2027Exclusivity NP Edurant Ped
  • 15 September 2027Exclusivity PED Edurant Ped
  • 23 October 2037Patent 11065198 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.