.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Amphotericin b - Generic Drug Details

« Back to Dashboard
Amphotericin b is the generic ingredient in five branded drugs marketed by X Gen Pharms, Apothecon, Sigma Tau, Abraxis Pharm, Alkopharma Usa, Astellas, Abbott, Bristol Myers Squibb, and Teva Parenteral, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-two patent family members in twenty-four countries.

There are fifteen drug master file entries for amphotericin b. Three suppliers are listed for this compound.

Summary for Generic Name: amphotericin b

Tradenames:5
Patents:3
Applicants:9
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amphotericin b

Clinical Trials for: amphotericin b

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon
FUNGIZONE
amphotericin b
LOTION;TOPICAL060570-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Abraxis Pharm
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION062728-001Apr 13, 1987DISCNNo<disabled><disabled>
X Gen Pharms
AMPHOTERICIN B
amphotericin b
INJECTABLE;INJECTION063206-001Apr 29, 1992RXYes<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: amphotericin b

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 19955,616,334<disabled>
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 19975,874,104<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: amphotericin b

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,948,441 Method for size separation of particles<disabled in preview>
6,770,290 Amphotericin B liposome preparation<disabled in preview>
4,963,297 Spontaneous vesticulation of multilamellar liposomes<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: amphotericin b

Country Document Number Estimated Expiration
Luxembourg88684<disabled in preview>
Norway180147<disabled in preview>
Germany3864495<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc