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Amphotericin B Patent Expiration

Amphotericin B was first introduced by Apothecon Inc Div Bristol Myers Squibb in its drug Fungizone on Approved Prior to Jan 1, 1982. Other drugs containing Amphotericin B are Ambisome, Amphotec, Abelcet. 11 different companies have introduced drugs containing Amphotericin B.


Amphotericin B Patents

Given below is the list of patents protecting Amphotericin B, 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
Abelcet US5616334 Low toxicity drug-lipid systems Apr 01, 2014

(Expired)

 Leadiant Biosci Inc
Abelcet US6406713 Methods of preparing low-toxicity drug-lipid complexes Jun 18, 2019

(Expired)

 Leadiant Biosci Inc
Ambisome US5874104 Treatment of systemic fungal infections with phospholipid particles encapsulating polyene antibiotics Feb 23, 2016

(Expired)

 Astellas
Ambisome US5965156 Amphotericin B liposome preparation Oct 12, 2016

(Expired)

 Astellas


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Amphotericin B Generics

Several generic applications have been filed for Amphotericin B. The first generic version for Amphotericin B was by Apothecon Inc Div Bristol Myers Squibb and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Nov 17, 2022.

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


1. SPIL

Sun Pharma Industries Ltd has filed for 1 generic for Amphotericin B. Given below are the details of the strengths of this generic introduced by Spil.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL injectable, liposomal Prescription INJECTION AB Dec 14, 2021


2. ABRAXIS PHARM

Abraxis Pharmaceutical Products has filed for 1 generic for Amphotericin B. Given below are the details of the strengths of this generic introduced by Abraxis Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL injectable Discontinued INJECTION N/A Apr 13, 1987


3. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Amphotericin B. 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
50MG/VIAL injectable, liposomal Prescription INJECTION AB Nov 17, 2022


4. APOTHECON

Apothecon Inc Div Bristol Myers Squibb has filed for 2 different strengths of generic version for Amphotericin B. All of these versions come by the name FUNGIZONE. Given below are the details of the strengths of this generic introduced by Apothecon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL injectable Discontinued INJECTION N/A Approved Prior to Jan 1, 1982
3% lotion Discontinued TOPICAL N/A Approved Prior to Jan 1, 1982


5. ABBOTT

Abbott Laboratories has filed for 1 generic for Amphotericin B. Given below are the details of the strengths of this generic introduced by Abbott.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL injectable Discontinued INJECTION N/A Dec 23, 1996


6. TEVA PARENTERAL

Teva Parenteral Medicines Inc has filed for 1 generic for Amphotericin B. Given below are the details of the strengths of this generic introduced by Teva Parenteral.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL injectable Discontinued INJECTION N/A Mar 31, 1995


7. XGEN PHARMS

Xgen Pharmaceuticals Djb Inc has filed for 1 generic for Amphotericin B. Given below are the details of the strengths of this generic introduced by Xgen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/VIAL

(reference standard)

injectable Prescription INJECTION N/A Apr 29, 1992