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 Fyarro, Hyftor. 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.

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 Sub
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 Sub
Fyarro US12133844 Methods of treating epithelioid cell tumors Jun 29, 2036 Aadi Sub
Fyarro US10705070 Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Mar 05, 2036 Aadi Sub
Fyarro US12061183 Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Mar 05, 2036 Aadi Sub
Fyarro US10206887 Prion free nanoparticle compositions and methods of making thereof Apr 15, 2030 Aadi Sub
Fyarro US8911786 Nanoparticle comprising rapamycin and albumin as anticancer agent Feb 14, 2029 Aadi Sub
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



Sirolimus's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

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.