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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 thirty-eight approved drugs.

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

There are five patent family members on AMNEAL PHARMS drugs in five countries and four hundred and thirty-five supplementary protection certificates in sixteen countries.

Summary for Amneal Pharms

International Patents:	5
US Patents:	1
Tradenames:	186
Ingredients:	181
NDAs:	238

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	CELECOXIB	celecoxib	CAPSULE;ORAL	208833-004	May 31, 2018	AB	RX	No	No
Amneal Pharms Llc	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-002	Dec 28, 2006	AB	RX	Yes	No
Amneal Pharms	CELECOXIB	celecoxib	CAPSULE;ORAL	208833-002	May 31, 2018	AB	RX	No	No
Amneal Pharms Llc	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	210509-001	Jan 2, 2020	AB	RX	No	No
Amneal Pharms	DUTASTERIDE	dutasteride	CAPSULE;ORAL	203118-001	Nov 20, 2015	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

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

International Patents for Amneal Pharms Drugs

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

Supplementary Protection Certificates for Amneal Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
1412357	122008000046	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

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 Llc
• Amneal Pharms Ny