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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Harvard Business School
Colorcon
Citi
Cerilliant
Fish and Richardson
McKinsey
Boehringer Ingelheim

Generated: August 20, 2018

DrugPatentWatch Database Preview

Mayne Pharma Company Profile

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Summary for Mayne Pharma
International Patents:45
US Patents:8
Tradenames:62
Ingredients:45
NDAs:65
Patent Litigation for Mayne Pharma: See patent lawsuits for Mayne Pharma

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 DIAZEPAM diazepam TABLET;ORAL 071134-001 Feb 3, 1987 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma Inc BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital CAPSULE;ORAL 207313-001 Dec 27, 2017 RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 203107-001 Jul 26, 2012 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma Inc BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 203335-001 Oct 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No 8,715,724 ➤ Sign Up Y ➤ Sign Up
Mayne Pharma FENTANYL-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077062-001 Aug 20, 2007 AB RX No No ➤ Sign Up ➤ Sign Up
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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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 ➤ Sign Up
Mayne Pharma TRI-NORINYL 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 018977-002 Apr 13, 1984 4,390,531 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MAYNE PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Delayed-release Tablets 80 mg ➤ Subscribe 2015-07-01
➤ Subscribe Delayed-release Tablets 60 mg and 120 mg ➤ Subscribe 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
6,730,288 Mousse composition ➤ Sign Up
8,298,515 Vitamin formulation ➤ Sign Up
2,016,151,395 ➤ Sign Up
7,029,659 Mousse composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Mayne Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000024 Germany ➤ Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2014 00016 Denmark ➤ Sign Up 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
00002 Netherlands ➤ Sign Up PRODUCT NAME: DOFETILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/99/121/001 - EU/1/99/121/015 19991129
C0021 Belgium ➤ Sign Up PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
C0004 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
C/GB00/005 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Chubb
McKesson
McKinsey
Harvard Business School
Dow
Cerilliant
Moodys
Covington

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.