Posaconazole Patent Expiration

Posaconazole is used for preventing and treating fungal infections in severely immunocompromised patients aged 2 years and older. It was first introduced by Schering Corp in its drug Noxafil on Sep 15, 2006. Another drug containing Posaconazole is Noxafil Powdermix Kit. 19 different companies have introduced drugs containing Posaconazole.


Posaconazole Patents

Given below is the list of patents protecting Posaconazole, 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
Noxafil US10117951 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme
Noxafil US5661151 Tetrahydrofuran antifungals Jul 19, 2019

(Expired)

Schering
Noxafil US5661151 Tetrahydrofuran antifungals Jul 19, 2019

(Expired)

Merck Sharp Dohme
Noxafil US5703079 Tetrahydrofuran antifungals Aug 26, 2014

(Expired)

Schering
Noxafil US5703079 Tetrahydrofuran antifungals Aug 26, 2014

(Expired)

Merck Sharp Dohme
Noxafil US6958337 Crystalline antifungal polymorph Oct 05, 2018

(Expired)

Schering
Noxafil US8263600 Antifungal composition with enhanced bioavailability Apr 01, 2022

(Expired)

Schering
Noxafil US8410077 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme
Noxafil US9023790 Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin Jul 04, 2031 Merck Sharp Dohme
Noxafil US9358297 Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin Jun 24, 2031 Merck Sharp Dohme
Noxafil US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same Feb 27, 2033 Merck Sharp Dohme
Noxafil US9750822 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme


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Posaconazole Generics

Several generic applications have been filed for Posaconazole. The first generic version for Posaconazole was by Sinotherapeutics Inc and was approved on Aug 21, 2019. And the latest generic version is by Gland Pharma Ltd and was approved on Dec 26, 2023.

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


1. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG/16.7ML (18MG/ML) solution Prescription INTRAVENOUS AP Dec 26, 2023


2. I 3 PHARMS

I 3 Pharmaceuticals Llc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by I 3 Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Aug 28, 2023


3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB May 15, 2020


4. SPECGX LLC

Specgx Llc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB May 10, 2022


5. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Dec 8, 2022


6. BIOCON PHARMA

Biocon Pharma Ltd has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Feb 4, 2022


7. AMNEAL

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Dec 22, 2022


8. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG/16.7ML (18MG/ML) solution Prescription INTRAVENOUS AP Dec 26, 2023


9. AET PHARMA

Aet Pharma Us Inc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Aet Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Feb 1, 2021


10. SINOTHERAPEUTICS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Aug 21, 2019


11. WESTMINSTER PHARMS

Westminster Pharmaceuticals Llc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Westminster Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Jun 20, 2023


12. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Posaconazole. 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
100MG tablet, delayed release Prescription ORAL AB Apr 7, 2022


13. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG/16.7ML (18MG/ML) solution Prescription INTRAVENOUS AP Dec 26, 2023


14. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Discontinued ORAL N/A Nov 30, 2022


15. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG/16.7ML (18MG/ML) solution Prescription INTRAVENOUS AP Dec 26, 2023


16. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Posaconazole. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG/16.7ML (18MG/ML) solution Prescription INTRAVENOUS AP May 25, 2022