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Generic competition · all medicines · read 12 November 2026

Is there a generic of Ruxolitinib Phosphate, and who makes it?

Ruxolitinib Phosphate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 3 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. 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.
Ruxolitinib Phosphate3 dosage-form groups in the Orange Book
0generic makers listed
  1. Ruxolitinib Phosphate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 3 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. 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, Extended Release, Oral

Brand listed, no generic listed as marketed

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

202020252030203501brand 2026data datePatent 9814722 listed to expire 12 December 2026Patent 9206187 listed to expire 12 December 2026Patent 9079912 listed to expire 12 December 2026Patent 11744832 listed to expire 12 December 2026Patent 8530485 listed to expire 12 December 2026Patent 7598257 listed to expire 24 December 2027Patent 8415362 listed to expire 24 December 2027Patent 8829013 listed to expire 12 June 2028Patent 10016429 listed to expire 12 June 2028Patent 8822481 listed to expire 12 June 2028Patent 8722693 listed to expire 12 June 2028Patent 11213528 listed to expire 12 June 2028Patent 8415362*PED listed to expire 24 June 2028Patent 7598257*PED listed to expire 24 June 2028Patent 8829013*PED listed to expire 12 December 2028Patent 10016429*PED listed to expire 12 December 2028Patent 8822481*PED listed to expire 12 December 2028Patent 11213528*PED listed to expire 12 December 2028Patent 8722693*PED listed to expire 12 December 2028Patent 11576864 listed to expire 14 November 2033Patent 11896717 listed to expire 14 November 2033Patent 11576865 listed to expire 14 November 2033Patent 10874616 listed to expire 14 November 2033Patent 11337927 listed to expire 17 January 2034Patent 10874616*PED listed to expire 14 May 2034Patent 11576864*PED listed to expire 14 May 2034Patent 11896717*PED listed to expire 14 May 2034Patent 11576865*PED listed to expire 14 May 2034Patent 11337927*PED listed to expire 17 July 2034Exclusivity ODE* to 22 September 2028Exclusivity PED to 22 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 September 2028Exclusivity ODE* Jakafi Xr
  • 22 March 2029Exclusivity PED Jakafi Xr
  • 12 December 2026Patent 9814722
  • 12 December 2026Patent 9206187
  • 12 December 2026Patent 9079912
  • 12 December 2026Patent 11744832
  • 12 December 2026Patent 8530485 drug product
  • 24 December 2027Patent 7598257 drug substance
  • 24 December 2027Patent 8415362 drug substance
  • 12 June 2028Patent 8829013

21 more patents are listed.

Tablet, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2011data datePatent 9079912 listed to expire 12 December 2026Patent 9814722 listed to expire 12 December 2026Patent 9079912*PED listed to expire 12 June 2027Patent 9814722*PED listed to expire 12 June 2027Patent 7598257 listed to expire 24 December 2027Patent 8415362 listed to expire 24 December 2027Patent 8822481 listed to expire 12 June 2028Patent 8829013 listed to expire 12 June 2028Patent 10016429 listed to expire 12 June 2028Patent 8722693 listed to expire 12 June 2028Patent 7598257*PED listed to expire 24 June 2028Patent 8415362*PED listed to expire 24 June 2028Patent 8722693*PED listed to expire 12 December 2028Patent 8822481*PED listed to expire 12 December 2028Patent 8829013*PED listed to expire 12 December 2028Patent 10016429*PED listed to expire 12 December 2028Exclusivity PED to 24 November 2026Exclusivity ODE-373 to 22 September 2028Exclusivity PED to 22 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 24 November 2026Exclusivity PED Jakafi
  • 22 September 2028Exclusivity ODE-373 Jakafi
  • 22 March 2029Exclusivity PED Jakafi
  • 12 December 2026Patent 9079912
  • 12 December 2026Patent 9814722
  • 12 June 2027Patent 9079912*PED
  • 12 June 2027Patent 9814722*PED
  • 24 December 2027Patent 7598257 drug substance
  • 24 December 2027Patent 8415362 drug substance
  • 12 June 2028Patent 8822481
  • 12 June 2028Patent 8829013

8 more patents are listed.

Cream, Topical

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2021data datePatent 9079912 listed to expire 12 December 2026Patent 9974790 listed to expire 12 December 2026Patent 10639310 listed to expire 12 December 2026Patent 9079912*PED listed to expire 12 June 2027Patent 9974790*PED listed to expire 12 June 2027Patent 10639310*PED listed to expire 12 June 2027Patent 7598257 listed to expire 24 December 2027Patent 8415362 listed to expire 24 December 2027Patent 8822481 listed to expire 12 June 2028Patent 10610530 listed to expire 12 June 2028Patent 8722693 listed to expire 12 June 2028Patent 7598257*PED listed to expire 24 June 2028Patent 8415362*PED listed to expire 24 June 2028Patent 8722693*PED listed to expire 12 December 2028Patent 8822481*PED listed to expire 12 December 2028Patent 10610530*PED listed to expire 12 December 2028Patent 10869870 listed to expire 20 May 2031Patent 11219624 listed to expire 20 May 2031Patent 11590136 listed to expire 20 May 2031Patent 12544381 listed to expire 20 May 2031Patent 12564593 listed to expire 20 May 2031Patent 10758543 listed to expire 20 May 2031Patent 12226419 listed to expire 20 May 2031Patent 11571425 listed to expire 20 May 2031Patent 11219624*PED listed to expire 20 November 2031Patent 10758543*PED listed to expire 20 November 2031Patent 10869870*PED listed to expire 20 November 2031Patent 11590138 listed to expire 10 June 2040Patent 12233067 listed to expire 28 July 2040Patent 11510923 listed to expire 4 September 2040Patent 11590137 listed to expire 4 September 2040Patent 12589096 listed to expire 4 September 2040Patent 11602536 listed to expire 5 May 2041Exclusivity NPP to 18 September 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 18 September 2028Exclusivity NPP Opzelura
  • 12 December 2026Patent 9079912
  • 12 December 2026Patent 9974790
  • 12 December 2026Patent 10639310
  • 12 June 2027Patent 9079912*PED
  • 12 June 2027Patent 9974790*PED
  • 12 June 2027Patent 10639310*PED
  • 24 December 2027Patent 7598257 drug substance
  • 24 December 2027Patent 8415362 drug substance

25 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.