Injectafer is a drug owned by American Regent Inc. It is protected by 11 US drug patents filed from 2013 to 2023. Out of these, 6 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2028. Details of Injectafer's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7612109 | Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes |
Feb, 2026
(3 months from now) | Active |
| US11123321 | Aqueous iron carbohydrate complexes, their production and medicaments containing them |
Oct, 2023
(2 years ago) |
Expired
|
| US9376505 | Aqueous iron carbohydrate complexes, their production and medicaments containing them |
Oct, 2023
(2 years ago) |
Expired
|
| US10519252 | Aqueous iron carbohydrate complexes, their production and medicaments containing them |
Oct, 2023
(2 years ago) |
Expired
|
| US11590097 | Aqueous iron carbohydrate complexes, their production and medicaments containing them |
Oct, 2023
(2 years ago) |
Expired
|
| US11291645 | Aqueous iron carbohydrate complexes, their production and medicaments containing them |
Oct, 2023
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7754702 | Methods and compositions for administration of iron |
Feb, 2028
(2 years from now) | Active |
| US8895612 | Methods and compositions for administration of iron |
Jan, 2027
(1 year, 2 months from now) | Active |
| US11478502 | Methods and compositions for administration of iron |
Jan, 2027
(1 year, 2 months from now) | Active |
| US11364260 | Methods and compositions for administration of iron |
Jan, 2027
(1 year, 2 months from now) | Active |
| US11433091 | Methods and compositions for administration of iron |
Jan, 2027
(1 year, 2 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Injectafer's patents.
Latest Legal Activities on Injectafer's Patents
Given below is the list of recent legal activities going on the following patents of Injectafer.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Dec, 2023 | US9376505 (Litigated) |
| Interim Patent Term Extension Granted
Critical | 28 Nov, 2023 | US7612109 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 May, 2023 | US10519252 |
| Email Notification
Critical | 17 May, 2023 | US7612109 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 17 May, 2023 | US7612109 (Litigated) |
| Electronic Review
Critical | 17 May, 2023 | US7612109 (Litigated) |
| Email Notification
Critical | 05 Apr, 2023 | US11590097 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 05 Apr, 2023 | US11590097 |
| Petition Entered | 14 Mar, 2023 | US11590097 |
| Recordation of Patent Grant Mailed
Critical | 28 Feb, 2023 | US11590097 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Injectafer and ongoing
litigations to
help you estimate the early arrival of Injectafer generic.
Injectafer's Litigations
Injectafer been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 24, 2015, against patent number US8895612. The petitioner Pharmacosmos A/S, challenged the validity of this patent, with Luitpold Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Injectafer's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7754702 | June, 2015 |
Final Written Decision
(04 Jan, 2017) | Luitpold Pharmaceuticals, Inc. | Pharmacosmos A/S |
| US8895612 | June, 2015 |
Institution Denied
(08 Jan, 2016) | Luitpold Pharmaceuticals, Inc. | Pharmacosmos A/S |
| US8895612 | June, 2015 |
Terminated-Denied
(08 Jan, 2016) | Luitpold Pharmaceuticals, Inc. | Pharmacosmos A/S |
FDA has granted some exclusivities to Injectafer. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Injectafer,
regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying
the generic
launch. Given below are details of the exclusivities granted to
Injectafer.
Exclusivity Information
Injectafer holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Injectafer's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 25, 2016 |
| New Strength(NS) | Apr 28, 2024 |
| New Patient Population(NPP) | Nov 19, 2024 |
| New Indication(I-915) | May 31, 2026 |
Several oppositions have been filed on Injectafer's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Injectafer's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Injectafer patents.
Injectafer's Oppositions Filed in EPO
Injectafer has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 27, 2013, by Kernebeck Patentanwalts Gmbh. This opposition was filed on patent number EP10194332A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP07716309A | Apr, 2017 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | Generics [U.K.] Limited | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | Taylor Wessing LLP | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | HGF Limited | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | Pharmacosmos Holding A/S | Granted and Under Opposition |
| EP07716309A | Apr, 2017 | Hoffmann Eitle | Granted and Under Opposition |
| EP10194332A | Feb, 2013 | Kernebeck Patentanwalts GmbH | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Injectafer is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Injectafer's family patents as well as insights into
ongoing legal events
on those patents.
Injectafer's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Injectafer's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 15, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Injectafer Generics:
There are no approved generic versions for Injectafer as of now.
How can I launch a generic of Injectafer before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Injectafer's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Injectafer's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Injectafer -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/2 mL | 23 Sep, 2022 | 1 | 15 Feb, 2028 | ||
| 750 mg/15 mL | 27 Mar, 2019 | 1 | 15 Feb, 2028 | ||
| 1 g/20 mL | 15 Feb, 2022 | 1 | 15 Feb, 2028 |
About Injectafer
Injectafer is a drug owned by American Regent Inc. It is used for treating iron deficiency anemia in patients with various underlying conditions using intravenous ferric carboxymaltose. Injectafer uses Ferric Carboxymaltose as an active ingredient. Injectafer was launched by Am Regent in 2021.
Approval Date:
Injectafer was approved by FDA for market use on 28 April, 2021.
Active Ingredient:
Injectafer uses Ferric Carboxymaltose as the active ingredient. Check out other Drugs and Companies using Ferric Carboxymaltose ingredient
Treatment:
Injectafer is used for treating iron deficiency anemia in patients with various underlying conditions using intravenous ferric carboxymaltose.
Dosage:
Injectafer is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG IRON/2ML (50MG IRON/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 1GM IRON/20ML (50MG IRON/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 500MG IRON/10ML (50MG IRON/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 750MG IRON/15ML (50MG IRON/ML) | SOLUTION | Prescription | INTRAVENOUS |