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Am Regent Company Profile

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What is the competitive landscape for AM REGENT, and what generic alternatives to AM REGENT drugs are available?

AM REGENT has seventy approved drugs.

There are five US patents protecting AM REGENT drugs.

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

Summary for Am Regent

International Patents:	60
US Patents:	5
Tradenames:	63
Ingredients:	62
NDAs:	70

Drugs and US Patents for Am Regent

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	7,612,109		Y	Y
Am Regent	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091374-001	Feb 14, 2019	AP	RX	No	No
Am Regent	TORSEMIDE	torsemide	INJECTABLE;INJECTION	090656-002	Apr 21, 2010		DISCN	No	No
Am Regent	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	079186-001	Nov 18, 2009		DISCN	No	No
Am Regent	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	INJECTABLE;INJECTION	078331-001	Mar 27, 2007	AP	RX	No	No
Am Regent	CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	209088-001	Jul 27, 2017	AP	RX	No	No
Am Regent	DEXFERRUM	iron dextran	INJECTABLE;INJECTION	040024-001	Feb 23, 1996		DISCN	No	No

Expired US Patents for Am Regent

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	DEXFERRUM	iron dextran	INJECTABLE;INJECTION	040024-001	Feb 23, 1996	5,624,668

International Patents for Am Regent Drugs

Country	Patent Number	Estimated Expiration
Cyprus	1113387
World Intellectual Property Organization (WIPO)	2004037865
Brazil	0315452
Portugal	1973549
Germany	10249552
Portugal	1554315
European Patent Office	2626074

Supplementary Protection Certificates for Am Regent Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0694547	2002/028	Ireland		PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
0122707	96C0030	Belgium		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Am Regent