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	DORYX	doxycycline hyclate	CAPSULE, DELAYED RELEASE;ORAL	050582-002	Aug 13, 2001		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	8,846,648	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	ANNOVERA	ethinyl estradiol; segesterone acetate	RING;VAGINAL	209627-001	Aug 10, 2018		RX	Yes	Yes	11,529,308	⤷ Try a Trial	Y			⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,793,819	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	9,974,773	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	11,304,959	⤷ 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
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
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016	6,958,161	⤷ Try a Trial
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,815,929	⤷ Try a Trial
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-005	Apr 11, 2013	6,958,161	⤷ Try a Trial
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-004	Apr 11, 2013	6,958,161	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Delayed-release Tablets	200 mg	➤ Subscribe	2013-08-12

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Country	Patent Number	Estimated Expiration
Canada	2448278	⤷ Try a Trial
Ukraine	123099	⤷ Try a Trial
Spain	2296943	⤷ Try a Trial
Argentina	099872	⤷ Try a Trial
Moldova, Republic of	3310333	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2020257544	⤷ Try a Trial
Australia	2013277235	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0771217	07C0001	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0383579	C960030	Netherlands	⤷ Try a Trial	PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
3701944	PA2022508,C3701944	Lithuania	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
3701944	PA2022508	Lithuania	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
1635783	CA 2014 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0284288	SPC/GB98/002	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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