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Amneal Company Profile

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

AMNEAL has two hundred and ninety-seven approved drugs.

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

There are six patent family members on AMNEAL drugs in eight countries and five hundred and seventy-six supplementary protection certificates in sixteen countries.

Summary for Amneal

International Patents:	6
US Patents:	1
Tradenames:	230
Ingredients:	224
NDAs:	297
Patent Litigation for Amneal:	See patent lawsuits for Amneal
PTAB Cases with Amneal as petitioner:	See PTAB cases with Amneal as petitioner

Drugs and US Patents for Amneal

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharm	FLECAINIDE ACETATE	flecainide acetate	TABLET;ORAL	075442-003	Jul 31, 2001	AB	RX	No	No
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-002	Feb 1, 2018	AB	RX	No	No
Amneal Pharms Ny	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078477-003	Jan 16, 2008		DISCN	No	No
Amneal Pharms	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	202202-008	Mar 4, 2013	AB	RX	No	No
Amneal	LIDOCAINE	lidocaine	PATCH;TOPICAL	206463-001	Aug 24, 2020	AB	RX	No	No
Amneal	ELURYNG	ethinyl estradiol; etonogestrel	RING;VAGINAL	210830-001	Dec 11, 2019	AB	RX	No	No
Amneal Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010-003	Nov 23, 2015	AB	RX	No	No

Expired US Patents for Amneal

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247

Paragraph IV (Patent) Challenges for AMNEAL drugs

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

International Patents for Amneal Drugs

Country	Patent Number	Estimated Expiration
Portugal	2881109
European Patent Office	2881109
Spain	2795421
Canada	2879383
Russian Federation	2015100116
World Intellectual Property Organization (WIPO)	2013139179
Poland	2881109

Supplementary Protection Certificates for Amneal Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1135391	PA2011004,C1135391	Lithuania		PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2137537	92487	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140203
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
1381356	2014/004	Ireland		PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826

Similar Applicant Names

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

• Amneal
• Amneal Pharm
• Amneal Pharms
• Amneal Pharms Co
• Amneal Pharms Ny