Amneal Company Profile

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

AMNEAL has three hundred and twenty-five approved drugs.

There are two US patents protecting AMNEAL drugs.

There are nine patent family members on AMNEAL drugs in nine countries and six hundred and twenty-eight supplementary protection certificates in seventeen countries.

Summary for Amneal

International Patents:	9
US Patents:	2
Tradenames:	253
Ingredients:	246
NDAs:	325
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	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	207481-004	Sep 21, 2021		DISCN	No	No
Amneal	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	207481-002	Sep 21, 2021		DISCN	No	No
Amneal	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075939-003	Jun 9, 2004		DISCN	No	No
Amneal Pharms Co	BUMETANIDE	bumetanide	TABLET;ORAL	209724-001	Oct 18, 2017	AB	RX	No	No
Amneal Pharms	ARIPIPRAZOLE	aripiprazole	SOLUTION;ORAL	203906-001	Aug 14, 2015	AA	RX	No	Yes
Amneal	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	208888-001	Feb 17, 2017	AP	RX	No	No
Amneal Pharms	LACOSAMIDE	lacosamide	TABLET;ORAL	204857-001	Mar 17, 2022	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
Poland	2881109
Russian Federation	2015100116
World Intellectual Property Organization (WIPO)	2013139179
European Patent Office	2881109
Australia	2020323846
Portugal	2881109
World Intellectual Property Organization (WIPO)	2021021277

Supplementary Protection Certificates for Amneal Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137537	CA 2014 00035	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
0138504	2004C/004	Belgium		PRODUCT NAME: FULVESTRANT; REGISTRATION NO/DATE: EU/1/03/269/001 20040311
1467728	16C0019	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0763039	18/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
1135391	PA2011004	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
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116

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