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Last Updated: April 19, 2021

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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 seventy-seven approved drugs.

There are seventeen US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.

There are eighty-nine patent family members on MAYNE PHARMA drugs in twenty-three countries and fifty-seven supplementary protection certificates in fourteen countries.

Summary for Mayne Pharma
International Patents:89
US Patents:17
Tradenames:73
Ingredients:55
NDAs:77

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 Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313-004 Apr 29, 2016 AB RX No No   Start Trial   Start Trial
Mayne Pharma CLONIDINE clonidine SYSTEM;TRANSDERMAL 079090-003 Aug 20, 2010 AB RX No No   Start Trial   Start Trial
Mayne Pharma Inc DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 210789-001 Jun 3, 2020 AA RX No No   Start Trial   Start Trial
Mayne Pharma Inc HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 205657-001 Aug 3, 2015 DISCN No No   Start Trial   Start Trial
Mayne Pharma CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073589-001 Aug 28, 1992 AB RX No No   Start Trial   Start Trial
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes 8,771,739   Start Trial Y   Start Trial
Mayne Pharma Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090177-001 Oct 20, 2008 AA RX No No   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Mayne Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne Pharma Inc SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807-001 Oct 29, 2005 6,127,425   Start Trial
Mayne Pharma TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977-001 Apr 13, 1984 4,390,531   Start Trial
Mayne Pharma TRI-NORINYL 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 018977-002 Apr 13, 1984 4,390,531   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
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

Supplementary Protection Certificates for Mayne Pharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0245997 SPC/GB00/005 United Kingdom   Start Trial 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
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 300814 Netherlands   Start Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1453521 C 2015 029 Romania   Start Trial PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0770388 PA2009004 Lithuania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Dow
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim

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 verification 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.