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OmniRx › Tools › Generic competition check › Cyclosporine

Generic competition · all medicines · read 12 November 2026

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

Cyclosporine appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 9.9 and 19.1 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.
Cyclosporine5 dosage-form groups in the Orange Book
15generic makers listed
  1. Cyclosporine appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 between 9.9 and 19.1 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: Neoral and Sandimmune. 8 generic makers with 22 generic products listed as marketed; the first generic approval is dated 13 January 2000.

19901995200020052010201520202025203008brand 1990Sandoz Inc, first approval 13 January 2000Abbvie Inc, first approval 12 May 2000Dr Reddys Laboratories Sa, first approval 20 December 2000Apotex Inc, first approval 9 May 2002Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa, first approval 29 March 2005Onesource Softgels Pte Ltd, first approval 2 August 2022Qilu Pharmaceutical Co Ltd, first approval 15 September 2025Aurobindo Pharma Ltd, first approval 17 September 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc13 January 20002
Abbvie Inc12 May 20002
Dr Reddys Laboratories Sa20 December 20002
Apotex Inc9 May 20025
Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa29 March 20053
Onesource Softgels Pte Ltd2 August 20223
Qilu Pharmaceutical Co Ltd15 September 20252
Aurobindo Pharma Ltd17 September 20263

Patents and exclusivities still listed

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

Emulsion, Ophthalmic

Four or more generic makers listed

Brand listed as marketed: Restasis, Restasis Multidose and Verkazia. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 2 February 2022.

200020052010201520202025203006brand 2002Mylan Pharmaceuticals Inc, first approval 2 February 2022Teva Pharmaceuticals Usa Inc, first approval 14 December 2023Deva Holding As, first approval 21 May 2024Saptalis Pharmaceuticals Llc, first approval 5 July 2024Twi Pharmaceuticals Inc, first approval 21 January 2026Jiangsu Anbison Pharmaceutical Co Ltd, first approval 1 June 2026data datePatent 8298568 listed to expire 3 November 2027Patent 9132071 listed to expire 2 June 2029Exclusivity ODE-358 to 23 June 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Mylan Pharmaceuticals Inc2 February 20221
Teva Pharmaceuticals Usa Inc14 December 20231
Deva Holding As21 May 20241
Saptalis Pharmaceuticals Llc5 July 20241
Twi Pharmaceuticals Inc21 January 20261
Jiangsu Anbison Pharmaceutical Co Ltd1 June 20261

Patents and exclusivities still listed

  • 23 June 2028Exclusivity ODE-358 Verkazia
  • 3 November 2027Patent 8298568 drug product
  • 2 June 2029Patent 9132071 drug product

Solution, Oral

One to three generic makers listed

Brand listed as marketed: Neoral and Sandimmune. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 3 March 2000.

1980198519901995200020052010201520202025203001brand 1983Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa, first approval 25 March 2005data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa25 March 20051

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: Sandimmune. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 29 October 1999.

1980198519901995200020052010201520202025203001brand 1983Hikma Pharmaceuticals Usa Inc, first approval 29 October 1999data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc29 October 19991

Patents and exclusivities still listed

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

Solution, Ophthalmic

Brand listed, no generic listed as marketed

Brand listed as marketed: Cequa and Vevye. No generic is listed as marketed.

201520202025203020352040204501brand 2018data datePatent 8614178 listed to expire 13 December 2030Patent 8980839 listed to expire 23 August 2033Patent 9937225 listed to expire 23 August 2033Patent 10441630 listed to expire 23 August 2033Patent 12496326 listed to expire 29 September 2036Patent 11951153 listed to expire 28 February 2037Patent 10918694 listed to expire 28 February 2037Patent 10813976 listed to expire 22 September 2037Patent 11413323 listed to expire 11 October 2039Patent 12059449 listed to expire 1 April 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 13 December 2030Patent 8614178 drug product
  • 23 August 2033Patent 8980839 drug product
  • 23 August 2033Patent 9937225 drug product
  • 23 August 2033Patent 10441630 drug product
  • 29 September 2036Patent 12496326
  • 28 February 2037Patent 11951153
  • 28 February 2037Patent 10918694 drug product
  • 22 September 2037Patent 10813976 drug product

2 more patents are listed.

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.