Am Regent Company Profile

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AM REGENT has eighty approved drugs.

There are eight US patents protecting AM REGENT drugs.

There are sixty-seven patent family members on AM REGENT drugs in thirty-two countries and one hundred and forty-four 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	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-001	Apr 30, 2019		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Am Regent	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	207742-001	Jun 16, 2017	AO	RX	No	No		⤷ Sign Up				⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes	7,754,702	⤷ Sign Up				⤷ Sign Up
Am Regent	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	INJECTABLE;INJECTION	091104-001	Oct 8, 2009		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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	203565-004	Feb 4, 2022	11,123,321	⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	11,291,645	⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	11,590,097	⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020	10,519,252	⤷ Sign Up
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996	5,624,668	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	PA2008006	Lithuania	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
1554315	C01554315/01	Switzerland	⤷ Sign Up	PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022
1499331	SPC/GB13/034	United Kingdom	⤷ Sign Up	PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0145340	99C0005	Belgium	⤷ Sign Up	PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0771217	CA 2006 00038	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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