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HYFTOR

NDA

SIROLIMUS | N213478 | NOBELPHARMA CO LTD

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

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Today

12740970

Apr. 11, 2045

ODE-391

Mar. 22, 2029

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

402 trials from ClinicalTrials.gov — 57 recruiting, 38 active, 194 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Therapeutic Value of Sirolimus in Refractory Adult-Onset Still's Disease NCT07151157	N/A	Active	Ruijin Hospital	3	2025-08-30 → 2026-08-30
Effect of mTOR Inhibition & Other Metabolism Modulating Interventions on the Elderly [SubStudy Rapa & cMRI to Evaluate Cardiac Function]NCT04742777	Phase 2	Active	The University of Texas Health Science Center at San Antonio	20	2022-02-01 → 2026-10-16
Reduced Intensity Transplantation for Severe Sickle Cell Disease NCT04362293	Phase 2	Active	St. Jude Children's Research Hospital	46	2020-04-30 → 2029-08-01
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent NCT03952273	N/A	Active	Phillip Freeman	3,141	2019-08-14 → 2030-11-30
Haploidentical PBMC Transplant for Severe Congenital Anemias NCT00977691	Phase 1/2	Active	National Heart, Lung, and Blood Institute (NHLBI)	23	2009-12-14 → 2026-09-10
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions NCT06308419	Phase 1	Active	M.D. Anderson Cancer Center	18	2024-08-14 → 2031-02-01
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant NCT03192397	Phase 1/2	Active	Roswell Park Cancer Institute	35	2017-08-09 → 2027-05-21
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System NCT05540223	N/A	Active	Biotronik AG	1,861	2024-05-13 → 2032-02
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma NCT03778996	Phase 2	Active	Sarcoma Oncology Research Center, LLC	31	2020-01-03 → 2028-03-31
Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.NCT03225417	Phase 1/2	Active	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	142	2017-05-16 → 2024-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$1318.41

Highest Price

$1318.41

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73683-0101-10HYFTOR 0.2% GEL,TOP	$1318.41	FSS	Nobelpharma America, LLC	05/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Hyftor (2024)

Total Spending

$1.4M

Total Claims

375

Beneficiaries

Avg Cost/Unit

$183.60

Spending Trend

$109K(2022)→$916K(2023)→$1.4M(2024)

YoY Change:+1.2%

5yr CAGR:-1.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs6 inactive

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

FUJIAN KERUI PHARMACEUTICAL CO LTDSIROLIMUS

DMF 168902003

ROLABO OUTSOURCING SLSIROLIMUS INTERMEDIATE

DMF 423372025

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

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
May 19, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2%

RLD

1 patent1 exclusivity▴

GEL;TOPICAL | Approved: Mar 22, 2022

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12740970Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Apr 11, 2045	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
ODE-391	Mar 22, 2029	Active