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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Mallinckrodt
Medtronic
Boehringer Ingelheim
Moodys

Last Updated: January 18, 2020

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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 seventy approved drugs.

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

There are seventy-two patent family members on MAYNE PHARMA drugs in twenty-two countries and fifty-four supplementary protection certificates in twelve countries.

Summary for Mayne Pharma
International Patents:72
US Patents:13
Tradenames:67
Ingredients:50
NDAs:70
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 Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-002 Dec 28, 2017 AB RX No No   Start Trial   Start Trial
Mayne Pharma LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200407-001 Oct 25, 2011 AB RX No No   Start Trial   Start Trial
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   Start Trial   Start Trial
Mayne Pharma Intl TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes 9,713,642   Start Trial   Start Trial
Mayne Pharma Inc DOFETILIDE dofetilide CAPSULE;ORAL 207058-002 Jun 6, 2016 AB 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 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 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
➤ Subscribe Delayed-release Tablets 80 mg ➤ Subscribe 2015-07-01

Supplementary Protection Certificates for Mayne Pharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0398460 12/2004 Austria   Start Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
>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:

Merck
Dow
Johnson and Johnson
Boehringer Ingelheim
McKinsey
Medtronic

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