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Amneal Pharms Company Profile

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What is the competitive landscape for AMNEAL PHARMS, and when can generic versions of AMNEAL PHARMS drugs launch?

AMNEAL PHARMS has two hundred and forty-three 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 four hundred and twelve supplementary protection certificates in fourteen countries.

Summary for Amneal Pharms

International Patents:	5
US Patents:	1
Tradenames:	192
Ingredients:	186
NDAs:	243

Drugs and US Patents for Amneal Pharms

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	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	210831-012	Feb 19, 2019	AB1,AB2	RX	No	No
Amneal Pharms Ny	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	078780-002	Jan 21, 2010		OTC	No	No
Amneal Pharms	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	204838-003	Jun 17, 2016	AB	RX	No	No

Expired US Patents for Amneal Pharms

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

Paragraph IV (Patent) Challenges for AMNEAL PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	200 mcg/vial		2015-05-01
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	1 mg/mL, 50 mL vials		2011-12-16

International Patents for Amneal Pharms Drugs

Country	Patent Number	Estimated Expiration
Canada	2879383
European Patent Office	2881109
World Intellectual Property Organization (WIPO)	2013139179

Supplementary Protection Certificates for Amneal Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
2957286	CA 2018 00043	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1

Similar Applicant Names

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

• Amneal Pharm
• Amneal Pharms
• Amneal Pharms Co