Group 3: Liposomal amphotericin B — Competitive Intelligence Brief

Group 3: Liposomal amphotericin B (Group 3: Liposomal amphotericin B) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Polyene antifungal. Area: Infectious Disease.

phase 3 Polyene antifungal Ergosterol Infectious Disease Small molecule

Target snapshot

Group 3: Liposomal amphotericin B (Group 3: Liposomal amphotericin B) — Fundacion Nacional de Dermatologia. Liposomal amphotericin B binds to ergosterol in fungal cell membranes, disrupting membrane integrity and causing cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Group 3: Liposomal amphotericin B TARGET	Group 3: Liposomal amphotericin B	Fundacion Nacional de Dermatologia	phase 3	Polyene antifungal	Ergosterol
Mycostatin	nystatin	Generic (originally Squibb)	marketed	Polyene Antifungal [EPC]	Ergosterol (fungal cell membrane)	1954-01-01
Amphotericin B Deoxycholate	Amphotericin B Deoxycholate	Drugs for Neglected Diseases	marketed	Polyene antifungal	Ergosterol
Liposomal Amphotericin B	Liposomal Amphotericin B	Taiwan Liposome Company	marketed	Polyene antifungal	Ergosterol
Loceryl NL + Cosmetic varnish	Loceryl NL + Cosmetic varnish	Galderma R&D	marketed	Morpholine antifungal	Δ14-steroid reductase and Δ8→Δ7-isomerase (ergosterol biosynthesis pathway)
Nystatin oral suspension	Nystatin oral suspension	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Polyene macrolide antifungal	Ergosterol
Nystatin 10000U/ml	Nystatin 10000U/ml	Riyadh Colleges of Dentistry and Pharmacy	marketed	Polyene macrolide antifungal	Ergosterol

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Polyene antifungal class)

1. Bharat Serums and Vaccines Limited · 1 drug in this class
2. CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · 1 drug in this class
3. CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · 1 drug in this class
4. Dr. Falk Pharma GmbH · 1 drug in this class
5. Drugs for Neglected Diseases · 1 drug in this class
6. Federal University of Health Science of Porto Alegre · 1 drug in this class
7. Fundacion Nacional de Dermatologia · 1 drug in this class
8. Pfizer · 1 drug in this class
9. Poitiers University Hospital · 1 drug in this class
10. Taiwan Liposome Company · 1 drug in this class