Mayne Pharma Company Profile

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MAYNE PHARMA has fifteen approved drugs.

There are eighty US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.

There are four hundred and sixty-six patent family members on MAYNE PHARMA drugs in fifty-one countries and sixty-one supplementary protection certificates in fourteen countries.

International Patents:	466
US Patents:	80
Tradenames:	18
Ingredients:	14
NDAs:	15
Patent Litigation for Mayne Pharma:	See patent lawsuits for Mayne Pharma

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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
Mayne Pharma	DORYX	doxycycline hyclate	CAPSULE, DELAYED RELEASE;ORAL	050582-002	Aug 13, 2001		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	10,806,697	⤷ Sign Up	Y			⤷ Sign Up
Mayne Pharma Inc	HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	205658-001	Nov 17, 2015		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	10,568,891	⤷ Sign Up				⤷ Sign Up
Mayne Pharma	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077062-001	Aug 20, 2007		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,815,929	⤷ Sign Up
Mayne Pharma Commrcl	SOLTAMOX	tamoxifen citrate	SOLUTION;ORAL	021807-001	Oct 29, 2005	6,127,425	⤷ Sign Up
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	8,771,739	⤷ Sign Up
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-001	May 6, 2005	6,958,161	⤷ Sign Up
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-002	May 6, 2005	6,958,161	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Delayed-release Tablets	200 mg	➤ Subscribe	2013-08-12
➤ Subscribe	Delayed-release Tablets	80 mg	➤ Subscribe	2015-07-01
➤ Subscribe	Delayed-release Tablets	60 mg and 120 mg	➤ Subscribe	2017-09-28
➤ Subscribe	Delayed-release Tablets	150 mg	➤ Subscribe	2008-12-19
➤ Subscribe	Delayed-release Tablets	200 mg	➤ Subscribe	2014-05-19
➤ Subscribe	Delayed-release Tablets	50 mg	➤ Subscribe	2015-11-05

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands	⤷ Sign Up	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1214076	C01214076/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	CA 2016 00016	Denmark	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2782584	122021000080	Germany	⤷ Sign Up	PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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