FDA Orange Book · active-ingredient family
Pirfenidone
Pirfenidone is approved as 2 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ESBRIET · NDA 208780
2
Brand (NDA)
23
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESBRIETRLD×3 | LEGACY PHARMA | NDA 208780 | AB | Jan 11, 2017 | |
| ESBRIETRLD | LEGACY PHARMA | NDA 022535 | AB | Oct 15, 2014 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIRFENIDONE | AUROBINDO PHARMA | ANDA 212597 | AB | Apr 20, 2026 | |
| PIRFENIDONE×2 | AUROBINDO PHARMA | ANDA 212596 | AB | Aug 11, 2025 | |
| PIRFENIDONE | MACLEODS PHARMS LTD | ANDA 212748 | AB | Dec 18, 2024 | |
| PIRFENIDONE | CHARTWELL RX | ANDA 212404 | — | Aug 28, 2023 | |
| PIRFENIDONE×2 | CHARTWELL RX | ANDA 212403 | — | Aug 23, 2023 | |
| PIRFENIDONE | APOTEX | ANDA 212687 | — | Jun 09, 2023 | |
| PIRFENIDONE×2 | APOTEX | ANDA 212709 | AB | May 31, 2023 | |
| PIRFENIDONE×2 | HETERO LABS LTD V | ANDA 212674 | AB | Sep 21, 2022 | |
| PIRFENIDONE | SCIEGEN PHARMS | ANDA 212077 | AB | Aug 01, 2022 | |
| PIRFENIDONE×2 | SCIEGEN PHARMS | ANDA 212078 | AB | Aug 01, 2022 | |
| PIRFENIDONE×3 | AIZANT | ANDA 212747 | AB | Jul 21, 2022 | |
| PIRFENIDONE | LAURUS | ANDA 212724 | AB | Jul 19, 2022 | |
| PIRFENIDONE×3 | LAURUS | ANDA 212722 | AB | Jul 19, 2022 | |
| PIRFENIDONE | SANDOZ | ANDA 212600 | AB | Jun 13, 2022 | |
| PIRFENIDONE×2 | MSN | ANDA 212772 | AB | May 24, 2022 | |
| PIRFENIDONE×2 | ALEMBIC | ANDA 212708 | AB | May 20, 2022 | |
| PIRFENIDONE×2 | MICRO LABS | ANDA 212680 | AB | May 18, 2022 | |
| PIRFENIDONE×2 | SANDOZ | ANDA 212560 | AB | Apr 28, 2022 | |
| PIRFENIDONE×2 | AMNEAL | ANDA 212570 | AB | Mar 25, 2022 | |
| PIRFENIDONE×2 | ACCORD HLTHCARE | ANDA 212730 | AB | Jan 25, 2022 | |
| PIRFENIDONE×2 | TEVA PHARMS USA | ANDA 212759 | AB | Jan 25, 2022 | |
| PIRFENIDONE | ACCORD HLTHCARE | ANDA 212731 | AB | Jan 20, 2022 | |
| PIRFENIDONE | AMNEAL | ANDA 212569 | AB | Jan 03, 2022 |
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7988994 | Sep 22, 2026 | in 3 mo | ProductU-1602 |
| 7767225 | Sep 22, 2026 | in 3 mo | ProductU-1602 |
| 8753679 | Sep 22, 2026 | in 3 mo | ProductU-1602 |
| 7767700 | Dec 18, 2027 | in 1 yr 6 mo | U-1601 |
| 8420674 | Dec 18, 2027 | in 1 yr 6 mo | ProductU-1608 |
| 7696236 | Dec 18, 2027 | in 1 yr 6 mo | U-1601 |
| 8383150 | May 10, 2028 | in 1 yr 11 mo | ProductU-2361 |
| 8592462 | Apr 22, 2029 | in 2 yr 11 mo | U-1609 |
| 7566729 | Apr 22, 2029 | in 2 yr 11 mo | U-1600 |
| 7635707 | Apr 22, 2029 | in 2 yr 11 mo | U-1609 |
| 8609701 | Apr 22, 2029 | in 2 yr 11 mo | U-1610 |
| 8013002 | Jan 08, 2030 | in 3 yr 7 mo | U-1603 |
| 8318780 | Jan 08, 2030 | in 3 yr 7 mo | U-1606 |
| 7910610 | Jan 08, 2030 | in 3 yr 7 mo | U-1604 |
| 8754109 | Jan 08, 2030 | in 3 yr 7 mo | U-1612 |
| 8084475 | Jan 08, 2030 | in 3 yr 7 mo | U-1605 |
| 8648098 | Jan 08, 2030 | in 3 yr 7 mo | U-1611 |
| 7816383 | Jan 08, 2030 | in 3 yr 7 mo | U-1603 |
| 8778947 | Aug 30, 2033 | in 7 yr 4 mo | U-1613 |
| 10188637 | Mar 28, 2037 | in 10 yr 11 mo | Product |
Pirfenidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
