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OmniRx › Tools › Generic competition check › Tacrolimus

Generic competition · all medicines · read 12 November 2026

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

Tacrolimus appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 10.5 and 23.4 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.
Tacrolimus6 dosage-form groups in the Orange Book
15generic makers listed
  1. Tacrolimus appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 10.5 and 23.4 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: Prograf. 11 generic makers with 33 generic products listed as marketed; the first generic approval is dated 10 August 2009.

199019952000200520102015202020252030011brand 1994Sandoz Inc, first approval 10 August 2009Dr Reddys Laboratories Ltd, first approval 12 May 2010Mylan Pharmaceuticals Inc, first approval 17 September 2010Accord Healthcare Inc, first approval 31 August 2011Panacea Biotec Pharma Ltd, first approval 28 September 2012Strides Pharma Global Pte Ltd, first approval 22 July 2014Ajenat Pharmaceuticals Llc, first approval 30 November 2017Biocon Pharma Ltd, first approval 10 November 2020Concord Biotech Ltd, first approval 10 November 2020Glenmark Pharmaceuticals Ltd, first approval 10 November 2020Alkem Laboratories Ltd, first approval 12 November 2020data dateExclusivity ODE-360 to 16 July 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc10 August 20093
Dr Reddys Laboratories Ltd12 May 20103
Mylan Pharmaceuticals Inc17 September 20103
Accord Healthcare Inc31 August 20113
Panacea Biotec Pharma Ltd28 September 20123
Strides Pharma Global Pte Ltd22 July 20143
Ajenat Pharmaceuticals Llc30 November 20173
Biocon Pharma Ltd10 November 20203
Concord Biotech Ltd10 November 20203
Glenmark Pharmaceuticals Ltd10 November 20203
Alkem Laboratories Ltd12 November 20203

Patents and exclusivities still listed

  • 16 July 2028Exclusivity ODE-360 Prograf

Ointment, Topical

Four or more generic makers listed

Brand listed as marketed: Protopic. 4 generic makers with 7 generic products listed as marketed; the first generic approval is dated 9 September 2014.

200020052010201520202025203004brand 2000Fougera Pharmaceuticals Inc, first approval 9 September 2014Glenmark Pharmaceuticals Ltd, first approval 16 April 2018Accord Healthcare Inc, first approval 31 January 2019Encube Ethicals Private Ltd, first approval 10 October 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fougera Pharmaceuticals Inc9 September 20142
Glenmark Pharmaceuticals Ltd16 April 20182
Accord Healthcare Inc31 January 20192
Encube Ethicals Private Ltd10 October 20231

Patents and exclusivities still listed

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

Capsule, Extended Release, Oral

One to three generic makers listed

Brand listed as marketed: Astagraf Xl. 1 generic maker with 3 generic products listed as marketed; the first generic approval is dated 25 January 2024.

2010201520202025203001brand 2013Chengdu Suncadia Medicine Co Ltd, first approval 25 January 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Chengdu Suncadia Medicine Co Ltd25 January 20243

Patents and exclusivities still listed

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

Injectable, Injection

One to three generic makers listed

Brand listed as marketed: Prograf. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 25 August 2017.

19901995200020052010201520202025203001brand 1994Nexus Pharmaceuticals Llc, first approval 12 February 2025data dateExclusivity ODE-360 to 16 July 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Nexus Pharmaceuticals Llc12 February 20251

Patents and exclusivities still listed

  • 16 July 2028Exclusivity ODE-360 Prograf

Tablet, Extended Release, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Envarsus Xr. No generic is listed as marketed.

201520202025203001brand 2015data datePatent 11123331 listed to expire 30 May 2028Patent 11110081 listed to expire 30 May 2028Patent 12083103 listed to expire 30 May 2028Patent 10864199 listed to expire 30 May 2028Patent 10166190 listed to expire 30 May 2028Patent 9549918 listed to expire 30 May 2028Patent 11419823 listed to expire 30 May 2028Patent 12403095 listed to expire 30 May 2028Patent 8664239 listed to expire 30 August 2028Patent 8685998 listed to expire 30 August 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 30 May 2028Patent 11123331
  • 30 May 2028Patent 11110081
  • 30 May 2028Patent 12083103
  • 30 May 2028Patent 10864199
  • 30 May 2028Patent 10166190 drug product
  • 30 May 2028Patent 9549918 drug product
  • 30 May 2028Patent 11419823 drug product
  • 30 May 2028Patent 12403095 drug product

2 more patents are listed.

For Suspension, Oral

Brand listed, no generic listed as marketed

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

201520202025203001brand 2018data dateExclusivity ODE-360 to 16 July 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 July 2028Exclusivity ODE-360 Prograf

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.