Sirolimus Patent Expiration

Sirolimus is used for treating locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors (PECOMA) in adults. It was first introduced by Pf Prism Cv in its drug Rapamune on Sep 15, 1999. Other drugs containing Sirolimus are Hyftor, Fyarro. 14 different companies have introduced drugs containing Sirolimus.


Sirolimus Patents

Given below is the list of patents protecting Sirolimus, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Fyarro US11497737 Pharmaceutical compositions of albumin and rapamycin Oct 28, 2040 Aadi
Fyarro US10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin Jun 29, 2036 Aadi
Fyarro US12133844 Methods of treating epithelioid cell tumors Jun 29, 2036 Aadi
Fyarro US10705070 Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Mar 05, 2036 Aadi
Fyarro US12061183 Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Mar 05, 2036 Aadi
Fyarro US10206887 Prion free nanoparticle compositions and methods of making thereof Apr 15, 2030 Aadi
Fyarro US8911786 Nanoparticle comprising rapamycin and albumin as anticancer agent Feb 14, 2029 Aadi
Rapamune US5989591

(Pediatric)

Rapamycin formulations for oral administration Sep 11, 2018

(Expired)

Pf Prism Cv
Rapamune US5989591 Rapamycin formulations for oral administration Mar 11, 2018

(Expired)

Pf Prism Cv
Rapamune US5536729

(Pediatric)

Rapamycin formulations for oral administration Mar 30, 2014

(Expired)

Pf Prism Cv
Rapamune US5100899

(Pediatric)

Methods of inhibiting transplant rejection in mammals using rapamycin and derivatives and prodrugs thereof Jan 07, 2014

(Expired)

Pf Prism Cv
Rapamune US5536729 Rapamycin formulations for oral administration Sep 30, 2013

(Expired)

Pf Prism Cv
Rapamune US5100899 Methods of inhibiting transplant rejection in mammals using rapamycin and derivatives and prodrugs thereof Jul 07, 2013

(Expired)

Pf Prism Cv
Rapamune US5403833

(Pediatric)

Methods of inhibiting transplant rejecton in mammals using rapamycin and derivatives and prodrugs thereof Oct 04, 2012

(Expired)

Pf Prism Cv



About Veterinary Sirolimus

Sirolimus is used in a drug marketed by 1 company: Triviumvet.

Other drugs containing Sirolimus are: Felycin ca1 .

Sirolimus's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Sirolimus:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Partial Stem Cell Transplant for Sickle Cell Disease From Matched Donors National Heart, Lung, and Blood Institute (NHLBI) NA RECRUITING
(Sep 2, 2026)
PHASE1, PHASE2
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE) Case Comprehensive Cancer Center NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Sirolimus Treatment in Pediatric Patients With Ataxia-Telangiectasia Sara Elva Espinosa Padilla, MD NA COMPLETED
(Sep 1, 2026)
PHASE2
Improving the Results of Bone Marrow Transplantation for Patients With Severe Congenital Anemias National Heart, Lung, and Blood Institute (NHLBI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors Gustave Roussy, Cancer Campus, Grand Paris NA COMPLETED
(Aug 1, 2026)
PHASE1
Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease University of Pennsylvania NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Topical TOR-582 Treatment of Epistaxis in HHT Columbia University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) OrphAI Therapeutics NA RECRUITING
(Jul 1, 2026)
PHASE2
Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors Aadi Bioscience, Inc. NA COMPLETED
(Jul 1, 2026)
PHASE2
Effects of Sirolimus on Asymptomatic ApoE4 Carriers University of Missouri-Columbia NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD) Columbia University NA RECRUITING
(Jun 1, 2026)
PHASE1
Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma Christopher Strouse NA RECRUITING
(Jun 1, 2026)
PHASE1
Vertebrobasilar Dolichoectasia Treatment With Sirolimus Huashan Hospital NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma CSPC ZhongQi Pharmaceutical Technology Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease M.D. Anderson Cancer Center NA TERMINATED
(May 1, 2026)
PHASE1
Sirolimus for Nosebleeds in HHT Unity Health Toronto NA COMPLETED
(May 1, 2026)
PHASE2
Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis University Hospital, Toulouse NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma Sarcoma Alliance for Research through Collaboration NA RECRUITING
(May 1, 2026)
PHASE2
Vaccination Response Modulation With a Targeted Rapamycin Protocol Study Central Adelaide Local Health Network Incorporated NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor University of Calgary NA RECRUITING
(Apr 1, 2026)
PHASE2
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors Sarcoma Alliance for Research through Collaboration NA COMPLETED
(Apr 1, 2026)
PHASE2
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome. Steven Hays, MD NA RECRUITING
(Apr 1, 2026)
PHASE2
Non-myeloablative Haploidentical HCT Study for Patients With Sickle Cell Disease, Including Compromised Organ Function National Heart, Lung, and Blood Institute (NHLBI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol CellTrans Inc. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE3
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression H. Lee Moffitt Cancer Center and Research Institute NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms University of Miami NA RECRUITING
(Mar 1, 2026)
PHASE2
A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations Palvella Therapeutics, Inc. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Sirolimus for Leigh Syndrome Matthew Demczko NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE2
Low Dose Sirolimus in People With Post-Acute Sequelae of COVID-19 (PASC) Long COVID-19 Icahn School of Medicine at Mount Sinai NA RECRUITING
(Mar 1, 2026)
PHASE3


Sirolimus Generic API Manufacturers

Several generic applications have been filed for Sirolimus. The first generic version for Sirolimus was by Zydus Pharmaceuticals Usa Inc and was approved on Jan 8, 2014. And the latest generic version is by Rising Pharma Holdings Inc and was approved on Jul 15, 2025.

Given below is the list of companies who have filed for Sirolimus generic, along with the locations of their manufacturing plants worldwide.


Sirolimus News

Concept Medical's Manufacturing Expertise: Sirolimus Coated Balloon - OC Academy

03 Feb, 2026

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