Pharsight

1. Injectafer patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP07716309A	2017-04-20	STADA Arzneimittel AG	Granted and Under Opposition
EP07716309A	2017-04-20	Taylor Wessing LLP	Granted and Under Opposition
EP07716309A	2017-04-20	Generics [U.K.] Limited	Granted and Under Opposition
EP07716309A	2017-04-19	HGF Limited	Granted and Under Opposition
EP07716309A	2017-04-18	TEVA PHARMACEUTICAL INDUSTRIES, LTD.	Granted and Under Opposition
EP07716309A	2017-04-13	Pharmacosmos Holding A/S	Granted and Under Opposition
EP07716309A	2017-04-10	Hoffmann Eitle	Granted and Under Opposition
EP10194332A	2013-02-27	Kernebeck Patentanwalts GmbH	Opposition rejected

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7754702	June, 2015	FWD Entered	Luitpold Pharmaceuticals, Inc.	Pharmacosmos A/S
US8895612	June, 2015	Terminated-Denied	Luitpold Pharmaceuticals, Inc.	Pharmacosmos A/S

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11590097	AM REGENT	Aqueous iron carbohydrate complexes, their production and medicaments containing them	Oct, 2023 (21 days from now)
US11291645	AM REGENT	Aqueous iron carbohydrate complexes, their production and medicaments containing them	Oct, 2023 (21 days from now)
US11123321	AM REGENT	Aqueous iron carbohydrate complexes, their production and medicaments containing them	Oct, 2023 (21 days from now)
US9376505	AM REGENT	Aqueous iron carbohydrate complexes, their production and medicaments containing them	Oct, 2023 (21 days from now)
US7612109	AM REGENT	Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes	Feb, 2024 (4 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11478502	AM REGENT	Methods and compositions for administration of iron	Jan, 2027 (3 years from now)
US11364260	AM REGENT	Methods and compositions for administration of iron	Jan, 2027 (3 years from now)
US11433091	AM REGENT	Methods and compositions for administration of iron	Jan, 2027 (3 years from now)
US8895612	AM REGENT	Methods and compositions for administration of iron	Jan, 2027 (3 years from now)
US7754702	AM REGENT	Methods and compositions for administration of iron	Feb, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication (I)	May 31, 2026
New Patient Population (NPP)	Nov 19, 2024
New Strength (NS)	Apr 28, 2024

Drugs and Companies using FERRIC CARBOXYMALTOSE ingredient

Market Authorisation Date: 25 July, 2013

Treatment: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give...

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
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

Strength	Dosage	Availability
1GM IRON/20ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription
750MG IRON/15ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription
100MG IRON/2ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription
500MG IRON/10ML (50MG IRON/ML)	SOLUTION;INTRAVENOUS	Prescription