Ferric carboxymaltose - Generic Drug Details
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What are the generic sources for ferric carboxymaltose and what is the scope of freedom to operate?
Ferric carboxymaltose
is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ferric carboxymaltose has seventy-one patent family members in thirty-two countries.
There are two drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.
Summary for ferric carboxymaltose
International Patents: | 71 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
Clinical Trials: | 122 |
Patent Applications: | 137 |
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 |
---|---|
Pharmacosmos Therapeutics, Inc. | Phase 3 |
Asan Medical Center | Phase 3 |
Hospital de Santa Cruz, Portugal | Phase 4 |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INJECTAFER | Injection | ferric carboxymaltose | 100 mg/2 mL | 203565 | 1 | 2022-09-23 |
INJECTAFER | Injection | ferric carboxymaltose | 1 g/20 mL | 203565 | 1 | 2022-02-15 |
INJECTAFER | Injection | ferric carboxymaltose | 750 mg/15 mL | 203565 | 1 | 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 | SOLUTION;INTRAVENOUS | 203565-003 | Apr 28, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-004 | Feb 4, 2022 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Am Regent | INJECTAFER | ferric carboxymaltose | SOLUTION;INTRAVENOUS | 203565-002 | Oct 8, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | Title | Estimated Expiration |
---|---|---|---|
Germany | 10249552 | Wasserlösliche Eisen-Kohlenhydrat-Komplexe, deren Herstellung und diese enthaltende Arzneimittel | See Plans and Pricing |
Canada | 2953964 | METHODES ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON) | See Plans and Pricing |
Spain | 2364136 | See Plans and Pricing | |
Jordan | 3286 | متراكبات مائية من حديد و كربوهيدرات,انتاجها و ادوية تحتوي عليها (AQUEOUS IRON CARBOHYDRATE COMPLEXES,THEIR PRODUCTION AND MEDICAMENTS CONTAINING THEM) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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