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Mayne Pharma Company Profile

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What is the competitive landscape for MAYNE PHARMA, and when can generic versions of MAYNE PHARMA drugs launch?

MAYNE PHARMA has sixty-three approved drugs.

There are eight US patents protecting MAYNE PHARMA drugs.

There are forty-five patent family members on MAYNE PHARMA drugs in nineteen countries and forty-eight supplementary protection certificates in eleven countries.

Summary for Mayne Pharma

International Patents:	45
US Patents:	8
Tradenames:	60
Ingredients:	43
NDAs:	63

Drugs and US Patents for Mayne Pharma

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	TABLET, DELAYED RELEASE;ORAL	050795-001	May 6, 2005	AB	RX	Yes	No	6,958,161		Y
Mayne Pharma Inc	DOXYCYCLINE	doxycycline	CAPSULE;ORAL	209396-001	Sep 29, 2017	AB	RX	No	No
Mayne Pharma	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984		DISCN	No	No
Mayne Pharma Inc	LIOTHYRONINE SODIUM	liothyronine sodium	TABLET;ORAL	090097-001	Mar 20, 2009	AB	RX	No	No

Expired US Patents for Mayne Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984	4,390,531
Mayne Pharma	TRI-NORINYL 28-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018977-002	Apr 13, 1984	4,390,531

Paragraph IV (Patent) Challenges for MAYNE PHARMA drugs

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

Non-Orange Book US Patents for Mayne Pharma

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,298,515	Vitamin formulation
6,730,288	Mousse composition
2,016,151,395
7,029,659	Mousse composition

International Patents for Mayne Pharma Drugs

Country	Document Number	Estimated Expiration
New Zealand	508259
Singapore	173563
Australia	2005299253
Spain	2299258

Supplementary Protection Certificates for Mayne Pharma Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211

Similar Applicant Names

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

• Mayne Pharma
• Mayne Pharma Inc
• Mayne Pharma Intl