FDA-Approved Liposomes, LNPs & Generics
DIANT® Pharma · Regulatory Intelligence
Compiled from FDA public records · as of August 25, 2026
FDA-Approved Liposomes, LNPs & Generics
Every liposomal and lipid-nanoparticle (LNP) drug or biologic product approved by FDA, sorted by which center reviewed it — the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) — with application numbers and original approval dates. Where a branded product has one or more approved generic or 505(b)(2) equivalents, the first-to-market entrant is listed directly beneath it here; the full competitive field — ten applications across three products — is broken out separately below.
30
Total applications
25
CDER · NDA/ANDA (drug)
5
CBER · BLA (biologic)
10
Generic / 505(b)(2) entrants
2026
Most recent · mFLUSIVA, Aug 5
Approvals by year, 1995–2026
CDER
CBER
Generic
Discontinued
CDER
Doxil ’95
CBER
mFlusiva ’26
1995
2000
2005
2010
2015
2020
2025
Positioned by exact approval date. Hover or focus a point for the product, application number, and date — full detail is in the tables below.
CDER
Liposomal & LNP drug products
Reviewed as small-molecule or oligonucleotide drugs under the FD&C Act, approved via New Drug Application (NDA). This includes every classic liposomal chemotherapeutic and anti-infective, plus the one FDA-approved LNP-delivered siRNA — which stayed a drug, not a biologic, despite the nanoparticle chassis it shares with the mRNA vaccines below.
| Product | Formulation | Indication area | Route | NDA No. | Approved |
|---|---|---|---|---|---|
| Doxil doxorubicin HCl liposome | PEGylated liposome | Oncology | IV | 050718 | 1995-11-17 |
| Doxorubicin HCl Liposome Injection generic of Doxil · Sun Pharma Global FZE (1st of 5 — see full list below) generic | PEGylated liposome | Oncology | IV | 203263† | 2013-02-04 |
| DaunoXome daunorubicin citrate liposome discontinued | Liposome | Oncology | IV | 050704 | 1996-04-08 |
| Abelcet amphotericin B lipid complex | Lipid complex (ribbon, not vesicle) | Systemic fungal infection | IV | 050724 | 1995-11-21 |
| Amphotec amphotericin B cholesteryl sulfate discontinued | Lipid-cholesteryl complex (disc) | Systemic fungal infection | IV | 050740* | 1996-11 |
| AmBisome amphotericin B liposome | Liposome | Systemic fungal infection | IV | 050740 | 1997-08-11 |
| Amphotericin B Liposome for Injection generic of AmBisome · Sun Pharmaceutical Industries (1st of 4 — see full list below) generic | Liposome | Systemic fungal infection | IV | 212514 | 2021-12-14 |
| DepoCyt cytarabine liposome discontinued | Liposome (DepoFoam) | Lymphomatous meningitis | Intrathecal | 021041 | 1999-04-01 |
| Visudyne verteporfin liposome | Liposome | Photodynamic therapy (AMD) | IV | 021119 | 2000-04-12 |
| Definity perflutren lipid microsphere | Lipid-shell microbubble | Ultrasound contrast | IV | 021064 | 2001-07-31 |
| DepoDur morphine sulfate liposome discontinued | Liposome (DepoFoam) | Post-surgical analgesia | Epidural | 021692 | 2004-05-18 |
| Exparel bupivacaine liposome | Liposome (DepoFoam) | Local analgesia | Infiltration | 022496 | 2011-10-28 |
| Bupivacaine Liposome Injectable Suspension generic of Exparel · eVenus Pharmaceutical Labs (Hengrui) generic | Liposome (DepoFoam) | Local analgesia | Infiltration | 214348 | 2024-07-01 |
| Marqibo vincristine sulfate liposome | Liposome (sphingomyelin/cholesterol) | Oncology (ALL) | IV | 202497 | 2012-08-09 |
| Onivyde irinotecan liposome | PEGylated liposome | Oncology (pancreatic) | IV | 207793 | 2015-10-22 |
| Vyxeos daunorubicin + cytarabine liposome | Liposome (fixed-ratio) | Oncology (AML) | IV | 209401 | 2017-08-03 |
| Arikayce amikacin liposome | Liposome (inhaled) | Nontuberculous mycobacterial lung disease | Inhalation | 207356 | 2018-09-28 |
| Onpattro patisiran, LNP-siRNA | Lipid nanoparticle (siRNA) | hATTR amyloidosis | IV infusion | 210922 | 2018-08-10 |
* Amphotec’s NDA number is reported inconsistently across secondary sources; treat as approximate and confirm against Drugs@FDA before regulatory use. † NDA 203263 (generic Doxil) was approved via the 505(b)(2) hybrid pathway rather than a traditional ANDA — a common route for early liposomal generics given the bioequivalence complexity — but is commonly referred to as “generic Doxil.” All other application numbers verified against FDA/Drugs@FDA records.
Generic
Generic & 505(b)(2) equivalents
Every FDA-approved generic or hybrid-NDA equivalent found across the three CDER products with at least one competitor — ten applications from six sponsors, not just the first-to-market entrant. Grouped by reference product and sorted by approval date; the earliest entrant per group is flagged first. No CBER (biologic) entry has a generic equivalent: biologics would require a biosimilar BLA, and none has been filed against any of the mRNA–LNP vaccines.
| Generic product | Reference product | Route | Applicant | App No. | Approved |
|---|---|---|---|---|---|
| Doxorubicin HCl Liposome Injection first | Doxil · approved 1995 | IV | Sun Pharma Global FZE | 203263† | 2013-02-04 |
| Doxorubicin HCl Liposome Injection | Doxil · approved 1995 | IV | Dr. Reddy’s Laboratories | 208657 | 2017-05-15 |
| Doxorubicin HCl Liposome Injection | Doxil · approved 1995 | IV | Zydus Lifesciences | 212299 | 2020-09-10 |
| Doxorubicin HCl Liposome Injection | Doxil · approved 1995 | IV | Alembic Pharmaceuticals | 219199 | 2025-06-27 |
| Doxorubicin HCl Liposome Injection | Doxil · approved 1995 | IV | Qilu Pharmaceutical (Hainan) | 219881 | 2026-02-03 |
| Amphotericin B Liposome for Injection first | AmBisome · approved 1997 | IV | Sun Pharmaceutical Industries | 212514 | 2021-12-14 |
| Amphotericin B Liposome for Injection | AmBisome · approved 1997 | IV | Eugia Pharma | 214010 | 2022-11-17 |
| Amphotericin B Liposome for Injection | AmBisome · approved 1997 | IV | Avet Lifesciences | 215354 | 2025-06-02 |
| Amphotericin B Liposome for Injection | AmBisome · approved 1997 | IV | Mylan Laboratories | 212967 | 2025-06-30 |
| Bupivacaine Liposome Injectable Suspension first discontinued | Exparel · approved 2011 | Infiltration | eVenus Pharmaceutical Labs (Hengrui) | 214348 | 2024-07-01 |
Sourced from FDA/openFDA Drugs@FDA records, not press coverage, so this reflects the full approved field rather than launch announcements. † NDA 203263 was approved via the 505(b)(2) hybrid pathway rather than a traditional ANDA, but is commonly referred to as “generic Doxil” — see the CDER table above for detail. The Exparel generic’s FDA marketing-status field currently reads discontinued at the product level; the approval itself remains on record. A 2024 approval announced by ForDoz Pharma Corp (distributed by Lupin) for a doxorubicin HCl liposome generic could not be matched to a distinct application number in FDA’s public dataset as of compilation — treat the Doxil count above as a floor, not a ceiling.
CBER
LNP biologic products
Reviewed as biological products under the PHS Act, approved via Biologics License Application (BLA). All five are mRNA vaccines carried by an ionizable-lipid nanoparticle — the only FDA-approved product class where an LNP delivery system sits on the biologics side of the CDER/CBER line.
| Product | mRNA target | Sponsor | BLA (STN) | Approved |
|---|---|---|---|---|
| Comirnaty COVID-19 vaccine, mRNA | SARS-CoV-2 spike | Pfizer–BioNTech | 125742 | 2021-08-23 |
| Spikevax COVID-19 vaccine, mRNA | SARS-CoV-2 spike | Moderna | 125752 | 2022-01-31 |
| mResvia RSV vaccine, mRNA | RSV fusion (F) protein | Moderna | 125796 | 2024-06-14 |
| mNexspike COVID-19 vaccine, mRNA | SARS-CoV-2 spike (next-gen) | Moderna | 125835 | 2025-05-30 |
| mFlusiva influenza vaccine, mRNA new | Seasonal influenza (mRNA-1010) | Moderna | 125869 | 2026-08-05 |
mFlusiva was approved 19 days before this list was compiled — the first mRNA-based influenza vaccine cleared by FDA, under accelerated approval for ages 65+.
Reading the list
- Why Onpattro sits under CDER, not CBER. Patisiran is a small interfering RNA carried in an LNP — the same delivery chassis as the mRNA vaccines — but siRNA drug substances are regulated as chemical drugs under the FD&C Act, not as “biological products” under the PHS Act. The nanoparticle shell doesn’t decide the center; the drug substance does.
- Abelcet and Amphotec aren’t strictly liposomes. Both are lipid-drug complexes (a ribbon-like bilayer and a disc-like complex, respectively) rather than closed lipid vesicles, so some reviews exclude them from “true” liposome counts. They’re included here because FDA and most pharmaceutics literature group them with the liposomal amphotericin B franchise.
- Definity is a lipid microsphere, not a drug-delivery liposome. It’s a phospholipid-shelled, gas-filled ultrasound contrast agent — included because it shares the lipid-bilayer shell technology, not because it delivers a therapeutic payload.
- Three CDER products have approved generic or hybrid equivalents — and the field is larger than headlines suggest. Doxorubicin HCl liposome has five approved entrants (2013–2026), amphotericin B liposome has four (2021–2025), and bupivacaine liposome has one (2024). The inline row under each brand in the table above shows only the first-to-market entrant; the full list of all ten is broken out in its own section below. No CBER entry has a generic equivalent — biologics require a biosimilar BLA rather than an ANDA, and none has been filed for these mRNA–LNP vaccines.
- Scope. This covers products with liposomal or LNP formulations as the defining delivery technology. It excludes lipid emulsions (e.g., propofol), lipid-conjugated small molecules (e.g., amphotericin B deoxycholate), and GalNAc-conjugated oligonucleotides (e.g., Onpattro’s non-LNP siRNA cousins Givlaari, Oxlumo), none of which use a liposomal or nanoparticle lipid carrier.