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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. 20 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 US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same Feb 27, 2033 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 US10117951 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme
Noxafil US8410077 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme
Noxafil US9750822 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Merck Sharp Dohme
Noxafil US8263600 Antifungal composition with enhanced bioavailability Apr 01, 2022

(Expired)

 Schering
Noxafil US5661151 Tetrahydrofuran antifungals Jul 19, 2019

(Expired)

 Schering
Noxafil US5661151 Tetrahydrofuran antifungals Jul 19, 2019

(Expired)

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

(Expired)

 Schering
Noxafil US5703079 Tetrahydrofuran antifungals Aug 26, 2014

(Expired)

 Schering
Noxafil US5703079 Tetrahydrofuran antifungals Aug 26, 2014

(Expired)

 Merck Sharp Dohme



Posaconazole's Family Patents

Family Patents

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Posaconazole Generic API Manufacturers

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 Aurobindo Pharma Ltd and was approved on Jul 18, 2024.

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


1. 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





2. 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

(reference standard)

tablet, delayed release Prescription ORAL AB Feb 1, 2021





3. 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


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.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





4. AUROBINDO PHARMA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

tablet, delayed release Prescription ORAL AB Jul 18, 2024


Manufacturing Plant Locations
New

Aurobindo Pharma'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 Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





5. 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


Manufacturing Plant Locations
New

Biocon Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





6. 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





7. 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





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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





9. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC





10. 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





11. 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





12. 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





13. 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





14. 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





15. 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


Manufacturing Plant Locations
New

Sinotherapeutics Inc's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Sinotherapeutics Inc as present at those locations.

Country City Firm Name
China
Shanghai Sinotherapeutics Inc.





16. 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


Manufacturing Plant Locations
New

Specgx Llc'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 Specgx Llc as present at those locations.

Country City Firm Name
United States
Raleigh SpecGx LLC
Greenville SpecGx LLC
Saint Louis SpecGx LLC





17. 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