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Serving 500+ biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
McKinsey
Novartis
AstraZeneca
Colorcon
Argus Health
Fish and Richardson
Cerilliant
Harvard Business School

Generated: July 21, 2017

DrugPatentWatch Database Preview

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-five approved drugs.

There are eight US patents protecting MAYNE PHARMA drugs and there have been two Paragraph IV challenges on MAYNE PHARMA drugs in the past three years.

There are sixty-one patent family members on MAYNE PHARMA drugs in twenty-two countries.

Summary for Applicant: Mayne Pharma

Patents:8
Tradenames:58
Ingredients:41
NDAs:65
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma
NORTRIPTYLINE HYDROCHLORIDE
nortriptyline hydrochloride
CAPSULE;ORAL073553-001Mar 30, 1992ABRXNoNo► Subscribe► Subscribe
Mayne Pharma
CLOZAPINE
clozapine
TABLET;ORAL203807-001Sep 17, 2015ABRXNoNo► Subscribe► Subscribe
Mayne Pharma Inc
DOFETILIDE
dofetilide
CAPSULE;ORAL207058-001Jun 6, 2016ABRXNoNo► Subscribe► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-008May 20, 2016RXYesYes9,511,031► SubscribeY ► Subscribe
Mayne Pharma
DIAZEPAM
diazepam
TABLET;ORAL071134-001Feb 3, 1987ABRXNoNo► Subscribe► Subscribe
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Expired 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-21018977-001Apr 13, 19844,390,531► Subscribe
Mayne Pharma
TRI-NORINYL 28-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-28018977-002Apr 13, 19844,390,531► Subscribe
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Paragraph IV activity for MAYNE PHARMA drugs

Drugname Dosage Strength Tradename Submissiondate
doxycycline hyclate
Delayed-release Tablets50 mg
DORYX
11/5/2015
doxycycline hyclate
Delayed-release Tablets80 mg
DORYX
7/1/2015
doxycycline hyclate
Delayed-release Tablets200 mg
DORYX
5/19/2014
doxycycline hyclate (as of 6/10/14)
Delayed-release Tablets200 mg
DORYX
8/12/2013
doxycycline hyclate
Delayed-release Tablets150 mg
DORYX
12/19/2008

Non-Orange Book 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
6,730,288 Mousse composition► Subscribe
2,016,151,395► Subscribe
8,298,515Vitamin formulation► Subscribe
7,029,659Mousse composition► Subscribe
8,991,390Inhalation device and method► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Mayne Pharma Drugs

Country Document Number Estimated Expiration
New Zealand508259► Subscribe
Australia2006253913► Subscribe
Japan2012518662► Subscribe
Canada2784041► Subscribe
European Patent Office1872776► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Mayne Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
C0004Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Medtronic
McKinsey
Cipla
US Army
Dow
Argus Health
Boehringer Ingelheim
Federal Trade Commission
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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