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
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 |
| 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 |
Sirolimus's Family Patents
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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 Hetero Labs Ltd Unit V and was approved on Sep 16, 2024.
Given below is the list of companies who have filed for Sirolimus generic, along with the locations of their manufacturing plants worldwide.
1. 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 |
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 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
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3. 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 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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| United States |
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| Canada |
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| India |
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4. 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 |
|---|---|---|---|---|---|
| 1MG | tablet | Prescription | ORAL | AB | Oct 27, 2014 |
| 2MG | tablet | Prescription | ORAL | AB | Oct 27, 2014 |
5. 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 |
|---|---|---|---|---|---|
| 2MG | tablet | Prescription | ORAL | AB | Oct 16, 2020 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 16, 2020 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 16, 2020 |
6. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 1 generic for Sirolimus. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | solution | Prescription | ORAL | AA | Sep 16, 2024 |
7. 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 |
Manufacturing Plant Locations New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
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| India |
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| United States |
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8. 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 |
Manufacturing Plant Locations New
Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
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9. 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 |
Manufacturing Plant Locations New
Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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10. 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 |