AM REGENT Company Profile

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AM REGENT has eighty-two approved drugs.

There are nine US patents protecting AM REGENT drugs.

There are sixty-seven patent family members on AM REGENT drugs in thirty-two countries and two hundred and six supplementary protection certificates in fifteen countries.

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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	11,478,502	⤷ Subscribe				⤷ Subscribe
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-004	Feb 9, 2007		RX	Yes	No		⤷ Subscribe				⤷ Subscribe
Am Regent	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091374-001	Feb 14, 2019		DISCN	No	No		⤷ Subscribe				⤷ Subscribe
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes	7,754,702	⤷ Subscribe				⤷ Subscribe
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes	7,612,109	⤷ Subscribe	Y	Y		⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	11,590,097	⤷ Subscribe
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996	5,624,668	⤷ Subscribe
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021	9,376,505	⤷ Subscribe
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020	11,123,321	⤷ Subscribe
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022	11,590,097	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Country	Patent Number	Estimated Expiration
South Korea	100992178	⤷ Subscribe
South Korea	20230058047	⤷ Subscribe
Spain	2602433	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2004037865	⤷ Subscribe
Cyprus	1112680	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain	⤷ Subscribe	PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
2957286	CR 2018 00043	Denmark	⤷ Subscribe	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1441735	2008/010	Ireland	⤷ Subscribe	PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
0454511	99C0009	Belgium	⤷ Subscribe	PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0770388	09C0018	France	⤷ Subscribe	PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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