Ambisome is a drug owned by Astellas Pharma Us Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2016. Details of Ambisome's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5965156 | Amphotericin B liposome preparation |
Oct, 2016
(10 years ago) |
Expired
|
| US5874104 | Treatment of systemic fungal infections with phospholipid particles encapsulating polyene antibiotics |
Feb, 2016
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Ambisome is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Ambisome's family patents as well as insights into
ongoing legal events
on those patents.
Ambisome's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ambisome:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Ambisome's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 12, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ambisome Generic API suppliers:
Amphotericin B is the generic name for the brand Ambisome. 9 different companies have already filed for the generic of Ambisome, with Apothecon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ambisome's generic
Alternative Brands for Ambisome
Ambisome which is used for treating fungal infections., has several other brand drugs using the same active ingredient (Amphotericin B). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Leadiant Biosci Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphotericin B, Ambisome's active ingredient. Check the complete list of approved generic manufacturers for Ambisome
About Ambisome
Ambisome is a drug owned by Astellas Pharma Us Inc. It is used for treating fungal infections. Ambisome uses Amphotericin B as an active ingredient. Ambisome was launched by Astellas in 1997.
Approval Date:
Ambisome was approved by FDA for market use on 11 August, 1997.
Active Ingredient:
Ambisome uses Amphotericin B as the active ingredient. Check out other Drugs and Companies using Amphotericin B ingredient
Treatment:
Ambisome is used for treating fungal infections.
Dosage:
Ambisome is available in injectable, liposomal form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/VIAL | INJECTABLE, LIPOSOMAL | Prescription | INJECTION |