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Ferric carboxymaltose - Generic Drug Details
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What are the generic sources for ferric carboxymaltose and what is the scope of ferric carboxymaltose patent protection?
Ferric carboxymaltose
is the generic ingredient in one branded drug marketed by Luitpold and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ferric carboxymaltose has sixty-six patent family members in thirty-one countries.
There are seventeen drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.
Summary for ferric carboxymaltose
| International Patents: | 66 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 17 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 71 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ferric carboxymaltose |
| DailyMed Link: | ferric carboxymaltose at DailyMed |
Pharmacology for ferric carboxymaltose
| Ingredient-type | Iron |
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
US Patents and Regulatory Information for ferric carboxymaltose
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Luitpold | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Luitpold | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Luitpold | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for ferric carboxymaltose
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 |
|---|---|---|
| 8,431,549 | Methods and compositions for administration of iron | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ferric carboxymaltose
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2005115455 | ➤ Sign Up |
| South Korea | 20140117678 | ➤ Sign Up |
| Denmark | 2287204 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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