Viewing data from:

ASTAGRAF XL

NDA

TACROLIMUS | N204096 | ASTELLAS PHARMA US INC

3 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov — 55 recruiting, 39 active, 353 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma NCT00882895	Phase 2	Active	Washington University School of Medicine	18	2009-05-05 → 2028-06-01
Allogeneic Hematopoietic Stem Cell Transplantation With Briquilimab-Based Conditioning in Participants With GATA2 Deficiency NCT05907746	Phase 2	Active	National Cancer Institute (NCI)	13	2023-11-29 → 2028-07-31
A Blood Stem Cell Transplant for Sickle Cell Disease NCT03249831	Phase 1	Active	City of Hope Medical Center	3	2019-01-04 → 2027-01-25
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant NCT03779854	Phase 2	Active	Fred Hutchinson Cancer Center	45	2019-08-29 → 2027-08-31
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation NCT04018937	Phase 2	Active	Emory University	43	2019-03-22 → 2026-11
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant NCT02861417	Phase 2	Active	M.D. Anderson Cancer Center	204	2016-08-05 → 2028-08-31
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia NCT01885689	Phase 2	Active	City of Hope Medical Center	72	2014-02-10 → 2026-09-21
Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation NCT02782546	Phase 2	Active	Washington University School of Medicine	60	2017-01-30 → 2028-02-13
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)NCT05156710	Phase 2	Active	Sanofi	48	2022-06-09 → 2026-10-20

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$5.71

per ea

Lowest NADAC/Unit

$2.88

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00469067773ASTAGRAF XL 1 MG CAPSULE	$5.71	EA	Brand	—	2026-10-21
00469064773ASTAGRAF XL 0.5 MG CAPSULE	$2.88	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$58.93

Highest Price

$597.45

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-0647-73ASTAGRAF 0.5MG CAP,SA	$58.93	FSS	Astellas Pharma U.S., Inc.	09/29/2026
00469-0677-73ASTAGRAF 1MG CAP,SA	$118.89	FSS	Astellas Pharma U.S., Inc.	09/29/2026
00469-0687-73ASTAGRAF 5MG CAP,SA	$597.45	FSS	Astellas Pharma U.S., Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Astagraf XL (2024)

Total Spending

$498K

Total Claims

703

Beneficiaries

139

Avg Cost/Unit

$9.05

Spending Trend

$442K(2019)→$482K(2020)→$512K(2021)→$512K(2022)→$448K(2023)→$498K(2024)

YoY Change:-1.9%

5yr CAGR:+2.2%

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

Medicare Part B Spending

CMS physician-administered drug spending for Astagraf XL (2024)

Total Spending

$2.6M

Total Claims

4,894

Beneficiaries

472

ASP Price

$0.56

Spending Trend

$6.4M(2019)→$5.4M(2020)→$4.2M(2021)→$3.5M(2022)→$3.0M(2023)→$2.6M(2024)

YoY Change:+3.9%

5yr CAGR:+3.6%

HCPCS: J7508 — Tacrolimus, extended release, (astagraf xl), oral, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain24 active DMFs7 inactive

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

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)TACROLIMUS USP

DMF 418282025

ASTELLAS PHARMA INCTACROLIMUS (FK506) DRUG SUBSTANCE

DMF 168332003

BIOCON LTDTACROLIMUS USP

DMF 184422005

CONCORD BIOTECH LTDTACROLIMUS USP

DMF 189082005

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS

DMF 189852005

LEK PHARMACEUTICALS DDTACROLIMUS

DMF 199792006

FUJIAN KERUI PHARMACEUTICAL CO LTDTACROLIMUS, NON-STERILE, BULK DRUG SUBSTANCE

DMF 218082008

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS SD20

DMF 232132009

HISUN PHARMACEUTICAL HANGZHOU CO LTDTACROLIMUS USP

DMF 272022013

MURLI KRISHNA PHARMA PVT LTDTACROLIMUS PELLETS 5.0% W/W

DMF 276262013

APOTEX INCTACROLIMUS USP

DMF 280652014

TAPI NL BVTACROLIMUS

DMF 285242014

BIOCON LTDTACROLIMUS GRANULES 20% W/W

DMF 297862015

CKD BIO CORPTACROLIMUS NON STERILE API

DMF 310972016

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDTACROLIMUS USP

DMF 312252016

LEK PHARMACEUTICALS DDTACROLIMUS (PROCESS II)

DMF 340632020

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDTACROLIMUS USP

DMF 342702020

CONCORD BIOTECH LTDTACROLIMUS USP (PROCESS II)

DMF 344912020

FARMHISPANIA SATACROLIMUS USP

DMF 358522021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTACROLIMUS (PROCESS B)

DMF 383102023

LUNAN NEW TIME BIO-TECH CO LTDTACROLIMUS

DMF 389852023

BIOCON LTDTACROLIMUS USP (PROCESS II)

DMF 395732024

WUXI FORTUNE PHARMACEUTICAL CO LTDTACROLIMUS

DMF 398162024

CHENGDU YACHT BIOTECHNOLOGY CO LTDTACROLIMUS

DMF 404482024

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 190722005

HANGZHOU HUADONG MEDICINE GROUP BIOTECHNOLOGY INSTITUTE CO LTDInactiveTACROLIMUS

DMF 203902007

ANTIBIOTICOS SPAInactiveTACROLIMUS MONOHYDRATE

DMF 222542008

BIOCON LTDInactiveTACROLIMUS (PRODUCT CODE 8000255)

DMF 233652009

JOYANG LABORATORIESInactiveTacrolimus

DMF 346302020

LUNAN NEW TIME BIO-TECH CO LTDInactiveTACROLIMUS USP

DMF 379822023

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)InactiveTACROLIMUS USP

DMF 396672024

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2023	SUPPL -11	View Letter (PDF)
Nov 25, 2022	SUPPL -10	View Letter (PDF)
Dec 31, 2020	SUPPL -9	View Letter (PDF)
Jun 12, 2019	SUPPL -7	View Letter (PDF)
Dec 20, 2018	SUPPL -5	View Letter (PDF)
Dec 18, 2015	SUPPL -3	View Letter (PDF)
Dec 18, 2015	SUPPL -4	View Letter (PDF)
Mar 4, 2014	SUPPL -2	View Letter (PDF)
Feb 12, 2014	SUPPL -1	View Letter (PDF)
Jul 26, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.5MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 19, 2013

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 19, 2013

#003 — EQ 5MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jul 19, 2013