Amneal Company Profile

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AMNEAL has three hundred and eighty-four approved drugs.

There are five US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.

There are fifteen patent family members on AMNEAL drugs in twelve countries and seven hundred and ninety-nine supplementary protection certificates in eighteen countries.

International Patents:	15
US Patents:	5
Tradenames:	291
Ingredients:	283
NDAs:	384
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	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	212704-003	Sep 22, 2023		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724-001	Sep 7, 2017	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-002	Jul 31, 2023		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		RX	Yes	No	11,654,124	⤷ Try a Trial	Y			⤷ Try a Trial
>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	021450-004	Sep 30, 2003	5,466,699*PED	⤷ Try a Trial
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	6,750,237*PED	⤷ Try a Trial
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	6,750,237*PED	⤷ Try a Trial
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Nasal Spray	2.5 mg/spray	➤ Subscribe	2016-06-09
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2962690	C20190029 00295	Estonia	⤷ Try a Trial	PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
0933372	PA2008006,C0933372	Lithuania	⤷ Try a Trial	PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0268956	SPC/GB98/040	United Kingdom	⤷ Try a Trial	PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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