interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Dabigatran Etexilate Mesylate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Dabigatran Etexilate Mesylate, and who makes it?

Dabigatran Etexilate Mesylate 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.
Dabigatran Etexilate Mesylate2 dosage-form groups in the Orange Book
8generic makers listed
  1. Dabigatran Etexilate Mesylate 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.

Capsule, Oral

Four or more generic makers listed

Brand listed as marketed: Pradaxa. 8 generic makers with 23 generic products listed as marketed; the first generic approval is dated 11 March 2020.

20102015202020252030203508brand 2010Alkem Laboratories Ltd, first approval 11 March 2020Hetero Labs Ltd Unit Iii, first approval 6 May 2020Apotex Inc, first approval 15 December 2023Msn Laboratories Private Ltd, first approval 22 May 2024Alembic Pharmaceuticals Ltd, first approval 14 June 2024Dr Reddys Laboratories Ltd, first approval 28 January 2025Mylan Pharmaceuticals Inc, first approval 3 February 2025Aurobindo Pharma Ltd, first approval 14 May 2025data datePatent 9034822 listed to expire 20 January 2031Patent 9034822*PED listed to expire 20 July 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Alkem Laboratories Ltd11 March 20203
Hetero Labs Ltd Unit Iii6 May 20203
Apotex Inc15 December 20233
Msn Laboratories Private Ltd22 May 20243
Alembic Pharmaceuticals Ltd14 June 20243
Dr Reddys Laboratories Ltd28 January 20253
Mylan Pharmaceuticals Inc3 February 20252
Aurobindo Pharma Ltd14 May 20253

Patents and exclusivities still listed

  • 20 January 2031Patent 9034822
  • 20 July 2031Patent 9034822*PED

Pellets, Oral

Brand listed, no generic listed as marketed

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

20202025203001brand 2021data 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.