Viewing data from:

FYARRO

NDA

SIROLIMUS | N213312 | AADI BIOSCIENCES INC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Feb. 14, 2029

Apr. 15, 2030

Mar. 5, 2036

Jun. 29, 2036

Oct. 28, 2040

Mar. 5, 2036

Jun. 29, 2036

ODE-386

Nov. 22, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Fyarro (2023)

Total Spending

$8.1M

Total Claims

423

Beneficiaries

ASP Price

—

HCPCS: J9331 — Injection, sirolimus protein-bound particles, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain16 active DMFs6 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

FUJIAN KERUI PHARMACEUTICAL CO LTDSIROLIMUS

DMF 168902003

LONZA AGSIROLIMUS

DMF 198132006

CURIA ITALY SRLSIROLIMUS

DMF 210372007

BIOCON LTDSIROLIMUS DRUG SUBSTANCE

DMF 215712008

CONCORD BIOTECH LTDSIROLIMUS

DMF 244682011

APOTEX INCSIROLIMUS DRUG SUBSTANCE

DMF 269042013

HANGZHOU HUADONG MEDICINE GROUP KANGRUN PHARMACEUTICAL CO LTDSIROLIMUS (INTERMEDIATE)

DMF 269832013

HISUN PHARMACEUTICAL HANGZHOU CO LTDSIROLIMUS

DMF 277252013

CHONGQING DAXIN PHARMACEUTICAL CO LTDSIROLIMUS

DMF 310522016

HEILONGJIANG WEIKAIER BIOTECHNOLOGY CO LTDSIROLIMUS

DMF 315272017

PARTNERS PHARMACEUTICALS INCSIROLIMUS (INTERMEDIATE)

DMF 350232020

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDSIROLIMUS

DMF 355272021

LUNAN NEW TIME BIO-TECH CO LTDSIROLIMUS

DMF 368582024

LUNAN NEW TIME BIO-TECH CO LTDSIROLIMUS INTERMEDIATE

DMF 368672022

YANGZHOU LIANAO BIOPHARMACEUTICAL CO LTDSIROLIMUS

DMF 370912022

ROLABO OUTSOURCING SLSIROLIMUS INTERMEDIATE

DMF 423372025

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveSIROLIMUS

DMF 231092009

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveSIROLIMUS

DMF 251472011

AADI BIOSCIENCES INCInactiveSIROLIMUS ALBUMIN-BOUND NANOPARTICLES FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-009)

DMF 285352015

PARTNERS PHARMACEUTICALS INCInactiveSIROLIMUS (INTERMEDIATE)

DMF 324142017

YANGZHOU LIANAO BIOPHARMACEUTICAL CO LTDInactiveSIROLIMUS (INTERMEDIATE OF DRUG SUBSTANCE)

DMF 330752018

TRIVIUMVETInactiveSIROLIMUS DELAYED-RELEASE TABLETS, 1.2 AND 2.4 MG

DMF 371032022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 24, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/VIAL

RLD

7 patents1 exclusivity▴

POWDER;INTRAVENOUS | Approved: Nov 22, 2021

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8911786	Feb 14, 2029	—	—	Yes		—
10206887	Apr 15, 2030	—	—	Yes	—	—
10705070	Mar 5, 2036	—	—	Yes	—	—
10973806	Jun 29, 2036	—	—	—		—
11497737	Oct 28, 2040	—	—	Yes	—	—
12061183	Mar 5, 2036	—	—	Yes	—	—
12133844	Jun 29, 2036	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-386	Nov 22, 2028	Active