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INJECTAFER Drug Profile
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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.
US ANDA Litigation and Generic Entry Outlook for Injectafer
Injectafer was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 5th, 2024. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
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 |
Paragraph IV (Patent) Challenges for INJECTAFER
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INJECTAFER | INJECTABLE;INTRAVENOUS | ferric carboxymaltose | 203565 | 2019-03-27 |
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 | 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 | |||
| Am Regent | INJECTAFER | ferric carboxymaltose | INJECTABLE;INTRAVENOUS | 203565-001 | Jul 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 INJECTAFER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5289413 | Start Trial |
| South Korea | 20170028449 | Start Trial |
| Norway | 20110654 | Start Trial |
| Russian Federation | 2303039 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
