DrugPatentWatch Database Preview
INJECTAFER Drug Profile
When do Injectafer patents expire, and what generic alternatives are available?
Injectafer is a drug marketed by Am Regent and is included in one NDA. There are four patents protecting this drug.
This drug has seventy patent family members in thirty-two countries.
The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
Summary for INJECTAFER
| International Patents: | 70 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 15 |
| Drug Prices: | Drug price information for INJECTAFER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INJECTAFER |
| DailyMed Link: | INJECTAFER at DailyMed |
Generic Entry Opportunity Date for INJECTAFER
Generic Entry Date for INJECTAFER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for INJECTAFER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sandoz | Phase 1 |
| New York University School of Medicine | Phase 2 |
| Pharmacosmos A/S | Phase 3 |
Recent Litigation for INJECTAFER
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 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Pharmacosmos A/S | 2015-06-24 |
Pharmacology for INJECTAFER
| Drug Class | Parenteral Iron Replacement Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
US Patents and Regulatory Information for INJECTAFER
| 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 | See Pricing | See Pricing | Y | See Pricing | |||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See 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 INJECTAFER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101365458 | See Pricing |
| European Patent Office | 2626074 | See Pricing |
| Spain | 2602433 | See Pricing |
| Poland | 1973549 | See Pricing |
| Cyprus | 1112680 | See Pricing |
| Israel | 166747 | See Pricing |
| Canada | 2635894 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
