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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fuji
US Army
US Department of Justice
Chubb
McKesson
Medtronic
Cipla
Johnson and Johnson
Daiichi Sankyo

Generated: November 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-four 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-two patent family members on MAYNE PHARMA drugs in twenty-two countries and forty-six supplementary protection certificates in eleven countries.

Summary for Mayne Pharma

International Patents:62
US Patents:8
Tradenames:59
Ingredients:42
NDAs:64
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma
DIAZEPAM
diazepam
TABLET;ORAL071134-001Feb 3, 1987ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma Inc
OXYCODONE AND ASPIRIN
aspirin; oxycodone hydrochloride
TABLET;ORAL091670-001Mar 16, 2011AARXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-008May 20, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Mayne Pharma Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL091313-002Feb 18, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078458-004Jun 23, 2016RXNoYes► Subscribe► Subscribe► Subscribe
Mayne Pharma
CYCLOSPORINE
cyclosporine
CAPSULE;ORAL065044-002Dec 20, 2000AB1RXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
LOW-OGESTREL-28
ethinyl estradiol; norgestrel
TABLET;ORAL-28075288-002Jul 28, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
CLONIDINE
clonidine
FILM, EXTENDED RELEASE;TRANSDERMAL079090-002Aug 20, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
TRIMETHOPRIM
trimethoprim
TABLET;ORAL018679-001Jul 30, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Mayne Pharma Inc
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET;ORAL208765-002Jun 14, 2017ABRXNoNo► Subscribe► 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, 1984► Subscribe► Subscribe
Mayne Pharma
TRI-NORINYL 28-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-28018977-002Apr 13, 1984► Subscribe► 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
8,991,390Inhalation device and method► Subscribe
2,016,151,395► Subscribe
8,298,515Vitamin formulation► Subscribe
7,029,659Mousse composition► 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
Japan6130992► Subscribe
Canada2784041► Subscribe
Hong Kong1221184► Subscribe
Japan2002524490► Subscribe
Japan6087887► Subscribe
Japan5612263► Subscribe
World Intellectual Property Organization (WIPO)2006045152► Subscribe
Brazil9913154► Subscribe
Australia2005299253► Subscribe
South Korea20110138353► 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
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2009004Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
C/GB00/005United Kingdom► SubscribePRODUCT NAME: DOFETILIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/99/121/001 19991129; UK EU/1/99/121/002 19991129; UK EU/1/99/121/003 19991129; UK EU/1/99/121/004 19991129; UK EU/1/99/121/005 19991129; UK EU/1/99/121/006 19991129; UK EU/1/99/121/007 19991129; UK EU/1/99/121/008 19991129; UK EU/1/99/121/009 19991129; UK EU/1/99/121/010 19991129; UK EU/1/99/121/011 19991129; UK EU/1/99/121/012 19991129; UK EU/1/99/121/013 19991129; UK EU/1/99/121/014 19991129; UK EU/1/99/121/015 19991129
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
2009004,C0770388Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
00C/005Belgium► SubscribePRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Cipla
QuintilesIMS
Moodys
Chinese Patent Office
US Department of Justice
AstraZeneca
Accenture
Citi
Dow

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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