cliffwatch

pirfenidone · Legacy · NDA 022535, 208780

Esbriet

Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Aug 2033

Other strengths are listed to 28 Mar 2037.

Blocked by patent: US 8778947, US 8778947, US 8778947. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 61 unexpired

PatentClaimsExpires
US 10188637product28 Mar 2037
US 8778947use U-204430 Aug 2033
US 8778947use U-204530 Aug 2033
US 8778947use U-161330 Aug 2033
US 7816383use U-20428 Jan 2030
US 7816383use U-20508 Jan 2030
US 7816383use U-16038 Jan 2030
US 7910610use U-20498 Jan 2030
US 7910610use U-20488 Jan 2030
US 7910610use U-16048 Jan 2030
US 8013002use U-20478 Jan 2030
US 8013002use U-20828 Jan 2030
US 8013002use U-16038 Jan 2030
US 8084475use U-20528 Jan 2030
US 8084475use U-20548 Jan 2030
US 8084475use U-16058 Jan 2030
US 8084475use U-22688 Jan 2030
US 8318780use U-20818 Jan 2030
US 8318780use U-16068 Jan 2030
US 8318780use U-20468 Jan 2030
US 8648098use U-20518 Jan 2030
US 8648098use U-20528 Jan 2030
US 8648098use U-16118 Jan 2030
US 8754109use U-20538 Jan 2030
US 8754109use U-16128 Jan 2030
US 7566729use U-227022 Apr 2029
US 7566729use U-226922 Apr 2029
US 7566729use U-160022 Apr 2029
US 7566729use U-207822 Apr 2029
US 7566729use U-207722 Apr 2029
US 7635707use U-207622 Apr 2029
US 7635707use U-207222 Apr 2029
US 7635707use U-207522 Apr 2029
US 7635707use U-207322 Apr 2029
US 7635707use U-208322 Apr 2029
US 7635707use U-207422 Apr 2029
US 7635707use U-160922 Apr 2029
US 8592462use U-206122 Apr 2029
US 8592462use U-206022 Apr 2029
US 8592462use U-160922 Apr 2029
US 8592462use U-206322 Apr 2029
US 8592462use U-205622 Apr 2029
US 8592462use U-205822 Apr 2029
US 8592462use U-205722 Apr 2029
US 8592462use U-206222 Apr 2029
US 8592462use U-205522 Apr 2029
US 8592462use U-205922 Apr 2029
US 8609701use U-206822 Apr 2029
US 8609701use U-206622 Apr 2029
US 8609701use U-206522 Apr 2029
US 8609701use U-206722 Apr 2029
US 8609701use U-206922 Apr 2029
US 8609701use U-206422 Apr 2029
US 8609701use U-207022 Apr 2029
US 8609701use U-161022 Apr 2029
US 8383150product, use U-236110 May 2028
US 7696236use U-160118 Dec 2027
US 7767700use U-160118 Dec 2027
US 7767700use U-208018 Dec 2027
US 8420674use U-207918 Dec 2027
US 8420674product, use U-160818 Dec 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic approved · 022535-001

Products covered · 4

NDA · productFormStrengthListed expiry
022535 · 001 · RLDcapsule, oral267MG30 Aug 2033
208780 · 001 · RLDtablet, oral267MG28 Mar 2037
208780 · 002 · RLD · discontinuedtablet, oral534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**28 Mar 2037
208780 · 003 · RLDtablet, oral801MG28 Mar 2037
Expired or delisted (3)
  • US 7767225 · product, use U-1602 · 22 Sep 2026
  • US 7988994 · product, use U-1602 · 22 Sep 2026
  • US 8753679 · product, use U-1602 · 22 Sep 2026