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OmniRx › Tools › Generic competition check › Entecavir

Generic competition · all medicines · read 12 November 2026

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

Entecavir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 9.4 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.
Entecavir2 dosage-form groups in the Orange Book
8generic makers listed
  1. Entecavir appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 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 9.4 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: Baraclude. 8 generic makers with 16 generic products listed as marketed; the first generic approval is dated 26 August 2014.

20052010201520202025203008brand 2005Hetero Labs Ltd Unit V, first approval 21 August 2015Aurobindo Pharma Ltd, first approval 26 August 2015Amneal Pharmaceuticals, first approval 12 November 2015Cipla Ltd, first approval 6 December 2016Zydus Pharmaceuticals Usa Inc, first approval 23 June 2017Brightgene Bio-Medical Technology Co Ltd, first approval 25 September 2019Yung Shin Pharmaceutical Industrial Co Ltd, first approval 10 November 2021Conba Usa Inc, first approval 23 December 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hetero Labs Ltd Unit V21 August 20152
Aurobindo Pharma Ltd26 August 20152
Amneal Pharmaceuticals12 November 20152
Cipla Ltd6 December 20162
Zydus Pharmaceuticals Usa Inc23 June 20172
Brightgene Bio-Medical Technology Co Ltd25 September 20192
Yung Shin Pharmaceutical Industrial Co Ltd10 November 20212
Conba Usa Inc23 December 20242

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Oral

Brand listed, no generic listed as marketed

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

20052010201520202025203001brand 2005data 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.