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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov — 8 recruiting, 4 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)NCT06428396	Phase 2	Active	Merck Sharp & Dohme LLC	120	2024-11-27 → 2028-12-25
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer NCT04188548	Phase 1	Active	Eli Lilly and Company	379	2019-12-10 → 2027-12
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)NCT07649798	N/A	Active	Advanced Bifurcation Systems Inc.	13	2025-09-16 → 2028-11-19
CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer NCT03032406	Phase 2	Active	Abramson Cancer Center at Penn Medicine	53	2017-01-23 → 2027-01-01
Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation NCT07162038	Phase 1	Recruiting	National Cancer Institute (NCI)	155	2025-11-14 → 2034-10-01
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry NCT07256249	—	Recruiting	Fundación EPIC	960	2025-12-11 → 2027-01-01
The Role of Sirolimus in Preventing Functional Decline in Older Adults NCT05237687	Phase 2	Recruiting	Irina Timofte	10	2026-03-31 → 2028-01
Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer NCT07318324	Phase 1	Recruiting	M.D. Anderson Cancer Center	31	2026-05-13 → 2030-08-01
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)NCT07405164	Phase 3	Recruiting	Merck Sharp & Dohme LLC	450	2026-03-23 → 2034-01-14
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies NCT02579967	Phase 2	Recruiting	National Cancer Institute (NCI)	354	2015-11-19 → 2036-12-31

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

Medicare Part D Spending

CMS annual spending data for Rapamune (2023)

Total Spending

$760K

Total Claims

399

Beneficiaries

Avg Cost/Unit

$28.77

Spending Trend

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

YoY Change:-2.2%

5yr CAGR:-0.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Rapamune (2023)

Total Spending

$7.2M

Total Claims

53,605

Beneficiaries

6,175

ASP Price

—

HCPCS: J7520 — Sirolimus, oral, 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

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.