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RAPAMUNE

NDA

SIROLIMUS | N021083 | PF PRISM CV

1 strength0 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

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Covington & Burling (on behalf of Wyeth Pharmaceuticals... FDA-2003P-0518 No FDA response document was found on the docket.	505(q)	2003-11-05	GrantedNo FDA response document on docket	Wyeth Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

378 trials from ClinicalTrials.gov — 40 recruiting, 34 active, 188 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive Therapy NCT02979873	Phase 2	Active	National Heart, Lung, and Blood Institute (NHLBI)	84	2016-12-19 → 2030-06-30
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
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
First in Men Study: BIOMAG-I NCT04157153	N/A	Active	Biotronik AG	116	2020-04-27 → 2027-02
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure NCT02105766	Phase 2	Active	National Heart, Lung, and Blood Institute (NHLBI)	56	2014-04-21 → 2027-12-31
Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease NCT03077542	Phase 1/2	Active	National Heart, Lung, and Blood Institute (NHLBI)	57	2017-04-06 → 2026-08-31
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity NCT00092222	Phase 2	Active	National Cancer Institute (NCI)	75	2004-10-28 → 2026-10-01
Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease NCT03933904	Phase 2	Active	University of Pennsylvania	7	2019-09-25 → 2027-06-30
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System NCT05540223	N/A	Active	Biotronik AG	1,861	2024-05-13 → 2032-02
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol NCT00679042	Phase 3	Active	CellTrans Inc.	21	2007-09-05 → 2026-06-14

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 1 NDC

Highest NADAC/Unit

$4.56

per ml

Lowest NADAC/Unit

$4.56

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762120506SIROLIMUS 1 MG/ML SOLUTION	$4.56	ML	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$483.49

Highest Price

$809.45

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-1205-06SIROLIMUS 1MG/ML SOLN,ORAL	$483.49	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-1205-06SIROLIMUS 1MG/ML SOLN,ORAL	$809.45	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Rapamune (2024)

Total Spending

$224K

Total Claims

150

Beneficiaries

Avg Cost/Unit

$26.33

Spending Trend

$2.4M(2019)→$1.8M(2020)→$1.2M(2021)→$888K(2022)→$760K(2023)→$224K(2024)

YoY Change:-8.5%

5yr CAGR:-2.5%

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 Rapamune (2024)

Total Spending

$4.4M

Total Claims

52,678

Beneficiaries

6,016

ASP Price

$1.95

Spending Trend

$19.4M(2019)→$17.0M(2020)→$14.7M(2021)→$8.5M(2022)→$7.2M(2023)→$4.4M(2024)

YoY Change:-37.3%

5yr CAGR:-25.4%

HCPCS: J7520 — Sirolimus, oral, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). 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

50 letters from Drugs@FDA

Date	Submission	Document
Aug 23, 2022	SUPPL -70	View Letter (PDF)
Aug 23, 2022	SUPPL -69	View Letter (PDF)
Jan 3, 2020	SUPPL -67	View Letter (PDF)
Jul 16, 2019	SUPPL -64	View Letter (PDF)
Jun 19, 2019	SUPPL -66	View Letter (PDF)
Apr 8, 2019	SUPPL -65	View Letter (PDF)
May 24, 2018	SUPPL -61	View Letter (PDF)
Jan 17, 2018	SUPPL -62	View Letter (PDF)
Nov 9, 2015	SUPPL -58	View Letter (PDF)
May 29, 2015	SUPPL -55	View Letter (PDF)
Mar 10, 2015	SUPPL -56	View Letter (PDF)
Sep 17, 2013	SUPPL -54	View Letter (PDF)
Mar 8, 2013	SUPPL -53	View Letter (PDF)
Dec 11, 2012	SUPPL -51	View Letter (PDF)
Jul 13, 2011	SUPPL -49	View Letter (PDF)
Jun 9, 2011	SUPPL -50	View Letter (PDF)
Dec 7, 2010	SUPPL -44	View Letter (PDF)
Dec 7, 2010	SUPPL -47	View Letter (PDF)
Nov 8, 2010	SUPPL -48	View Letter (PDF)
Jul 8, 2010	SUPPL -46	View Letter (PDF)
Apr 28, 2010	SUPPL -43	View Letter (PDF)
Apr 28, 2010	SUPPL -42	View Letter (PDF)
Feb 1, 2010	SUPPL -45	View Letter (PDF)
Nov 10, 2009	SUPPL -40	View Letter (PDF)
Nov 10, 2009	SUPPL -41	View Letter (PDF)
Mar 10, 2008	SUPPL -37	View Letter (PDF)
Mar 7, 2008	SUPPL -36	View Letter (PDF)
Jan 18, 2008	SUPPL -33	View Letter (PDF)
Oct 22, 2007	SUPPL -34	View Letter (PDF)
May 9, 2007	SUPPL -31	View Letter (PDF)
Feb 12, 2007	SUPPL -29	View Letter (PDF)
Jan 25, 2007	SUPPL -30	View Letter (PDF)
Jan 16, 2007	SUPPL -26	View Letter (PDF)
Jun 6, 2006	SUPPL -24	View Letter (PDF)
Jun 6, 2006	SUPPL -25	View Letter (PDF)
Oct 14, 2005	SUPPL -22	View Letter (PDF)
Oct 14, 2005	SUPPL -23	View Letter (PDF)
Jul 8, 2005	SUPPL -21	View Letter (PDF)
Jul 8, 2005	SUPPL -20	View Letter (PDF)
Mar 14, 2005	SUPPL -19	View Letter (PDF)
Jul 21, 2004	SUPPL -17	View Letter (PDF)
Jun 14, 2004	SUPPL -14	View Letter (PDF)
Oct 9, 2003	SUPPL -15	View Letter (PDF)
Apr 18, 2003	SUPPL -6	View Letter (PDF)
Jan 23, 2003	SUPPL -9	View Letter (PDF)
Jan 23, 2003	SUPPL -10	View Letter (PDF)
Jan 23, 2003	SUPPL -8	View Letter (PDF)
Jan 23, 2003	SUPPL -7	View Letter (PDF)
Jan 23, 2003	SUPPL -5	View Letter (PDF)
Sep 15, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 15, 1999

No patent or exclusivity listings for this strength.