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Amneal Pharms Company Profile

AMNEAL PHARMS has two hundred and twenty-nine approved drugs.

There is one US patent protecting AMNEAL PHARMS drugs. There are twelve tentative approvals on AMNEAL PHARMS drugs.

There are five patent family members on AMNEAL PHARMS drugs in five countries and three hundred and fifty-two supplementary protection certificates in thirteen 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
Amneal Pharms Llc	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	205666-001	Jul 19, 2018	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Amneal Pharms	IRBESARTAN	irbesartan	TABLET;ORAL	204740-001	Apr 17, 2018	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Amneal Pharms Ny	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078477-002	Jan 16, 2008		DISCN	No	No		➤ Sign Up				➤ Sign Up
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-002	Feb 1, 2018	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Amneal Pharms Llc	FENOFIBRATE	fenofibrate	TABLET;ORAL	209950-002	Mar 19, 2018	AB	RX	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
Amneal Pharms Llc	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24

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Country	Document Number	Estimated Expiration
European Patent Office	2881109	➤ Sign Up
Russian Federation	2015100116	➤ Sign Up
World Intellectual Property Organization (WIPO)	2013139179	➤ Sign Up
China	103315947	➤ Sign Up
Canada	2879383	➤ Sign Up
Country	Document Number	Estimated Expiration

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
156	Luxembourg	➤ Sign Up	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2009 00017	Denmark	➤ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C/GB08/020	United Kingdom	➤ Sign Up	SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
C/GB12/047	United Kingdom	➤ Sign Up	PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
C0050	France	➤ Sign Up	PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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