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. 12 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 US10206887 Prion free nanoparticle compositions and methods of making thereof Apr 15, 2030 Aadi
Fyarro US10705070 Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Mar 05, 2036 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 US11497737 Pharmaceutical compositions of albumin and rapamycin Oct 28, 2040 Aadi
Fyarro US8911786 Nanoparticle comprising rapamycin and albumin as anticancer agent Feb 14, 2029 Aadi
Rapamune US5100899 Methods of inhibiting transplant rejection in mammals using rapamycin and derivatives and prodrugs thereof Jul 07, 2013

(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 US5403833

(Pediatric)

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

(Expired)

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

(Expired)

Pf Prism Cv
Rapamune US5536729

(Pediatric)

Rapamycin formulations for oral administration Mar 30, 2014

(Expired)

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

(Expired)

Pf Prism Cv
Rapamune US5989591

(Pediatric)

Rapamycin formulations for oral administration Sep 11, 2018

(Expired)

Pf Prism Cv


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Sirolimus Generics

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 Zydus Pharmaceuticals Usa Inc and was approved on Feb 15, 2023.

Given below is the list of companies who have filed for Sirolimus generic.


1. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Sirolimus. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG tablet Prescription ORAL AB Jan 8, 2014
1MG tablet Prescription ORAL AB Feb 15, 2023
2MG tablet Prescription ORAL AB Feb 15, 2023


2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML solution Prescription ORAL AA Oct 18, 2019


3. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML solution Prescription ORAL AA Jan 28, 2019


4. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Sirolimus. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AB Mar 12, 2021
0.5MG tablet Prescription ORAL AB Mar 12, 2021
1MG tablet Prescription ORAL AB Mar 12, 2021


5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Sirolimus. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AB Oct 27, 2014
1MG tablet Prescription ORAL AB Oct 27, 2014


6. TORRENT

Torrent Pharma Inc has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML solution Discontinued ORAL N/A Dec 27, 2021


7. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Sirolimus. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG tablet Prescription ORAL AB Oct 16, 2020
0.5MG tablet Prescription ORAL AB Oct 16, 2020
2MG tablet Prescription ORAL AB Oct 16, 2020


8. APOTEX

Apotex Inc has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML solution Prescription ORAL AA Oct 22, 2019


9. MSN

Msn Laboratories Private Ltd has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML solution Prescription ORAL AA Jan 19, 2023