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-five 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	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,529,360	⤷ Try a Trial	Y			⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	8,846,648	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	9,114,146	⤷ Try a Trial	Y			⤷ Try a Trial
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	9,180,091	⤷ Try a Trial	Y			⤷ Try a Trial
Mayne Pharma	DORYX	doxycycline hyclate	CAPSULE, DELAYED RELEASE;ORAL	050582-001	Jul 22, 1985		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	10,398,708	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	11,246,875	⤷ Try a Trial				⤷ 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	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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Country	Patent Number	Estimated Expiration
Hungary	S2200027	⤷ Try a Trial
Israel	214520	⤷ Try a Trial
Australia	2021203265	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2013192249	⤷ Try a Trial
Argentina	095619	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2018227172	⤷ Try a Trial
Costa Rica	7420	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
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
1214076	C01214076/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0334429	97C0002	Belgium	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
3632448	LUC00266	Luxembourg	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
1453521	300814	Netherlands	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0836511	SPC/GB06/022	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
>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.