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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Teva
Argus Health
Julphar
Queensland Health
Cerilliant
Colorcon
Fish and Richardson
Accenture

Generated: October 19, 2018

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Mayne Pharma Company Profile

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What is the competitive landscape for MAYNE PHARMA, and what generic alternatives to MAYNE PHARMA drugs are available?

MAYNE PHARMA has sixty-five approved drugs.

There are eight US patents protecting MAYNE PHARMA drugs.

Summary for Mayne Pharma
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 NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073556-003 Mar 30, 1992 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma CYCLOSPORINE cyclosporine SOLUTION;ORAL 065054-001 Dec 18, 2001 AB1 RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070173-002 May 31, 1985 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma CLONIDINE clonidine FILM, EXTENDED RELEASE;TRANSDERMAL 079090-003 Aug 20, 2010 AB RX No No ➤ Sign Up ➤ Sign Up
Mayne Pharma SORILUX calcipotriene AEROSOL, FOAM;TOPICAL 022563-001 Oct 6, 2010 RX Yes Yes 8,629,128 ➤ Sign Up Y ➤ Sign Up
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No 9,446,057 ➤ Sign Up Y ➤ Sign Up
Mayne Pharma TRIVORA-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 074538-002 Dec 18, 1997 AB RX No Yes ➤ 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 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
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe 2013-08-12

Supplementary Protection Certificates for Mayne Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00523 Netherlands ➤ Sign Up PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
2009004 Lithuania ➤ Sign Up PRODUCT 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
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
2015000093 Germany ➤ Sign Up PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0003 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
60030 Netherlands ➤ Sign Up PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
00C/005 Belgium ➤ Sign Up PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 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.

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Covington
Cerilliant
Dow
Merck
Cantor Fitzgerald
Julphar
US Department of Justice
Daiichi Sankyo

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