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Ferric carboxymaltose - Generic Drug Details
What are the generic sources for ferric carboxymaltose and what is the scope of patent protection?
Ferric carboxymaltose
is the generic ingredient in one branded drug marketed by Am Regent 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 seventy patent family members in thirty-two countries.
There are twenty drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.
Summary for ferric carboxymaltose
| International Patents: | 70 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 2 |
| Clinical Trials: | 93 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ferric carboxymaltose |
| DailyMed Link: | ferric carboxymaltose at DailyMed |
Recent Clinical Trials for ferric carboxymaltose
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kepler University Hospital | Phase 4 |
| Asociación Instituto de Investigación Sanitaria BioCruces | Phase 4 |
| Konkuk University Medical Center | Phase 4 |
Recent Litigation for ferric carboxymaltose
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| VIFOR (INTERNATIONAL) AG v. SANDOZ INC. | 2019-08-02 |
| VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD. | 2019-06-18 |
See all ferric carboxymaltose litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Pharmacosmos A/S | 2015-06-24 |
Pharmacology for ferric carboxymaltose
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Paragraph IV (Patent) Challenges for FERRIC CARBOXYMALTOSE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INJECTAFER | INJECTABLE;INTRAVENOUS | ferric carboxymaltose | 203565 | 2019-03-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ferric carboxymaltose
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2493806 | Start Trial |
| Portugal | 1554315 | Start Trial |
| Saudi Arabia | 2095 | Start Trial |
| New Zealand | 539243 | Start Trial |
| Lithuania | 1973549 | Start Trial |
| >Country | >Patent 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.
ISSN: 2162-2639
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