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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Moodys
Baxter
McKinsey
Johnson and Johnson

Last Updated: May 26, 2022

Mayne Pharma Company Profile


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Summary for Mayne Pharma
International Patents:182
US Patents:19
Tradenames:73
Ingredients:55
NDAs:78

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 DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070173-002 May 31, 1985 AB RX No No See Plans and Pricing See Plans and Pricing
Mayne Pharma DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076137-003 Jan 18, 2002 DISCN No No See Plans and Pricing See Plans and Pricing
Mayne Pharma DISOPYRAMIDE PHOSPHATE disopyramide phosphate CAPSULE;ORAL 070173-001 May 31, 1985 AB RX No No See Plans and Pricing See Plans and Pricing
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 RX Yes Yes 11,020,407 See Plans and Pricing Y See Plans and Pricing
Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078458-002 Dec 1, 2011 AB1 RX No No See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing
Mayne Pharma TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977-001 Apr 13, 1984 4,390,531 See Plans and Pricing
Mayne Pharma TRI-NORINYL 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 018977-002 Apr 13, 1984 4,390,531 See Plans and Pricing
>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 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
➤ 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

Supplementary Protection Certificates for Mayne Pharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 CA 2009 00017 Denmark See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0398460 04C0022 France See Plans and Pricing PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1214076 C01214076/01 Switzerland See Plans and Pricing PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0836511 CA 2006 00019 Denmark See Plans and Pricing PRODUCT NAME: FENTANYL HYDROCHLORID
0328535 96C0021 Belgium See Plans and Pricing 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
>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

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