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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 twenty-six 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 forty-eight supplementary protection certificates in thirteen countries.

Summary for Amneal Pharms

International Patents:	5
US Patents:	1
Tradenames:	177
Ingredients:	171
NDAs:	226

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	DUTASTERIDE	dutasteride	CAPSULE;ORAL	203118-001	Nov 20, 2015	AB	RX	No	No
Amneal Pharms Ny	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	077824-001	Oct 13, 2006	AB	RX	No	No
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-001	Oct 12, 2004	AB	RX	No	Yes
Amneal Pharms	LORAZEPAM	lorazepam	TABLET;ORAL	078826-002	Jun 23, 2010	AB	RX	No	No
Amneal Pharms Co	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	208105-006	Mar 17, 2016	AB	RX	No	No
Amneal Pharms Ny	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078477-003	Jan 16, 2008		DISCN	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
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Injection	1 mg/mL, 50 mL vials		2011-12-16

International Patents for Amneal Pharms Drugs

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

Supplementary Protection Certificates for Amneal Pharms Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C/032	Belgium		PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
2015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
C0023	Belgium		PRODUCT NAME: MEROPENEM TRIHYDR; NAT. REGISTRATION NO/DATE: 624 IS 88 F 12 19960205; FIRST REGISTRATION: IT 028949028 19940817
C/GB98/048	United Kingdom		PRODUCT NAME: RALOXIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/98/073/001 19980805; UK EU/1/98/073/002 19980805; UK EU/1/98/073/003 19980805; UK EU/1/98/073/004 19980805; UK EU/1/98/074/001 19980805; UK EU/1/98/074/002 19980805; UK EU/1/98/074/003 19980805; UK EU/1/98/074/004 19980805
1506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015

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
• Amneal Pharms Llc
• Amneal Pharms Ny