Mayne Pharma Company Profile

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MAYNE PHARMA has fifteen approved drugs.

There are seventy-eight US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.

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

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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	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428-001	May 11, 2012		RX	Yes	Yes	8,808,716	⤷ Try a Trial	Y			⤷ Try a Trial
Mayne Pharma	LEXETTE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	210566-001	May 24, 2018	AB	RX	Yes	Yes	10,857,159*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,865,179	⤷ Try a Trial	Y	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
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-008	May 20, 2016	6,958,161	⤷ Try a Trial
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-001	May 6, 2005	6,958,161	⤷ Try a Trial
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	8,771,739	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Delayed-release Tablets	200 mg	➤ Subscribe	2014-05-19
➤ Subscribe	Delayed-release Tablets	50 mg	➤ Subscribe	2015-11-05
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	99C0003	Belgium	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0836511	SPC/GB06/022	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2782584	301153	Netherlands	⤷ Try a Trial	PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.