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. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

FDA has approved 1 generic application (ANDA) for Esbriet, though its earliest generic-entry date is 30 Aug 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 17 unexpired

61 Orange Book listing rows for 17 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10188637drug product28 Mar 2037
US 8778947use U-1613, U-2044, U-204530 Aug 2033
US 8778947 listing rowuse U-1613 · sets the listed date30 Aug 2033
US 8778947 listing rowuse U-2044 · sets the listed date30 Aug 2033
US 8778947 listing rowuse U-2045 · sets the listed date30 Aug 2033
US 7816383use U-1603, U-2042, U-20508 Jan 2030
US 7816383 listing rowuse U-16038 Jan 2030
US 7816383 listing rowuse U-20428 Jan 2030
US 7816383 listing rowuse U-20508 Jan 2030
US 7910610use U-1604, U-2048, U-20498 Jan 2030
US 7910610 listing rowuse U-16048 Jan 2030
US 7910610 listing rowuse U-20488 Jan 2030
US 7910610 listing rowuse U-20498 Jan 2030
US 8013002use U-1603, U-2047, U-20828 Jan 2030
US 8013002 listing rowuse U-16038 Jan 2030
US 8013002 listing rowuse U-20478 Jan 2030
US 8013002 listing rowuse U-20828 Jan 2030
US 8084475use U-1605, U-2052, U-2054, U-22688 Jan 2030
US 8084475 listing rowuse U-16058 Jan 2030
US 8084475 listing rowuse U-20528 Jan 2030
US 8084475 listing rowuse U-20548 Jan 2030
US 8084475 listing rowuse U-22688 Jan 2030
US 8318780use U-1606, U-2046, U-20818 Jan 2030
US 8318780 listing rowuse U-16068 Jan 2030
US 8318780 listing rowuse U-20468 Jan 2030
US 8318780 listing rowuse U-20818 Jan 2030
US 8648098use U-1611, U-2051, U-20528 Jan 2030
US 8648098 listing rowuse U-16118 Jan 2030
US 8648098 listing rowuse U-20518 Jan 2030
US 8648098 listing rowuse U-20528 Jan 2030
US 8754109use U-1612, U-20538 Jan 2030
US 8754109 listing rowuse U-16128 Jan 2030
US 8754109 listing rowuse U-20538 Jan 2030
US 7566729use U-1600, U-2077, U-2078, U-2269, U-227022 Apr 2029
US 7566729 listing rowuse U-160022 Apr 2029
US 7566729 listing rowuse U-207722 Apr 2029
US 7566729 listing rowuse U-207822 Apr 2029
US 7566729 listing rowuse U-226922 Apr 2029
US 7566729 listing rowuse U-227022 Apr 2029
US 7635707use U-1609, U-2072, U-2073, U-2074, U-2075, U-2076, U-208322 Apr 2029
US 7635707 listing rowuse U-160922 Apr 2029
US 7635707 listing rowuse U-207222 Apr 2029
US 7635707 listing rowuse U-207322 Apr 2029
US 7635707 listing rowuse U-207422 Apr 2029
US 7635707 listing rowuse U-207522 Apr 2029
US 7635707 listing rowuse U-207622 Apr 2029
US 7635707 listing rowuse U-208322 Apr 2029
US 8592462use U-1609, U-2055, U-2056, U-2057, U-2058, U-2059, U-2060, U-2061, U-2062, U-206322 Apr 2029
US 8592462 listing rowuse U-160922 Apr 2029
US 8592462 listing rowuse U-205522 Apr 2029
US 8592462 listing rowuse U-205622 Apr 2029
US 8592462 listing rowuse U-205722 Apr 2029
US 8592462 listing rowuse U-205822 Apr 2029
US 8592462 listing rowuse U-205922 Apr 2029
US 8592462 listing rowuse U-206022 Apr 2029
US 8592462 listing rowuse U-206122 Apr 2029
US 8592462 listing rowuse U-206222 Apr 2029
US 8592462 listing rowuse U-206322 Apr 2029
US 8609701use U-1610, U-2064, U-2065, U-2066, U-2067, U-2068, U-2069, U-207022 Apr 2029
US 8609701 listing rowuse U-161022 Apr 2029
US 8609701 listing rowuse U-206422 Apr 2029
US 8609701 listing rowuse U-206522 Apr 2029
US 8609701 listing rowuse U-206622 Apr 2029
US 8609701 listing rowuse U-206722 Apr 2029
US 8609701 listing rowuse U-206822 Apr 2029
US 8609701 listing rowuse U-206922 Apr 2029
US 8609701 listing rowuse U-207022 Apr 2029
US 8383150drug product, use U-236110 May 2028
US 7696236use U-160118 Dec 2027
US 7767700use U-1601, U-208018 Dec 2027
US 7767700 listing rowuse U-160118 Dec 2027
US 7767700 listing rowuse U-208018 Dec 2027
US 8420674drug product, use U-1608, U-207918 Dec 2027
US 8420674 listing rowdrug product, use U-160818 Dec 2027
US 8420674 listing rowuse U-207918 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

  • Generic approved · ANDA 212597, Aurobindo Pharma · 022535-001Approved 20 Apr 2026Detected 25 Oct 2026Historical import

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