Amneal Company Profile

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AMNEAL has four hundred and one approved drugs.

There are twenty-two US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.

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

International Patents:	136
US Patents:	22
Tradenames:	304
Ingredients:	294
NDAs:	401
Patent Litigation for Amneal:	See patent lawsuits for Amneal
PTAB Cases with Amneal as petitioner:	See PTAB cases with Amneal as petitioner

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077289-003	Nov 30, 2006	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
Amneal Pharms Co	ARGATROBAN	argatroban	INJECTABLE;INJECTION	206698-001	Jan 26, 2018	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Amneal Pharms Co	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	207482-002	Jun 28, 2017	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
Amneal	AZATHIOPRINE	azathioprine	TABLET;ORAL	074069-003	Nov 2, 2021	AB	RX	No	No		⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	6,750,237*PED	⤷ Subscribe
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247	⤷ Subscribe
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	6,750,237*PED	⤷ Subscribe
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	7,220,767*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Nasal Spray	2.5 mg/spray	➤ Subscribe	2016-06-09
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Nasal Spray	5 mg/spray	➤ Subscribe	2013-11-14
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	PA2021502	Lithuania	⤷ Subscribe	PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	C01467728/01	Switzerland	⤷ Subscribe	PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1304992	SPC/GB13/061	United Kingdom	⤷ Subscribe	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	PA2013025,C1304992	Lithuania	⤷ Subscribe	PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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