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Last Updated: May 8, 2024

Mayne Pharma Company Profile


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Summary for Mayne Pharma
International Patents:426
US Patents:78
Tradenames:18
Ingredients:14
NDAs:15

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 TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 RX Yes Yes 10,463,740 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma FABIOR tazarotene AEROSOL, FOAM;TOPICAL 202428-001 May 11, 2012 RX Yes Yes 8,808,716 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 10,052,386 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 AB RX Yes Yes 11,020,407 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No 9,114,146 ⤷  Try a Trial Y ⤷  Try a 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 TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 8,771,739 ⤷  Try a Trial
Mayne Pharma Commrcl SOLTAMOX tamoxifen citrate SOLUTION;ORAL 021807-001 Oct 29, 2005 6,127,425 ⤷  Try a Trial
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 8,815,929 ⤷  Try a Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 6,958,161 ⤷  Try a Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 6,958,161 ⤷  Try a 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
2782584 LUC00245 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
0136011 99C0003 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2588114 LUC00227 Luxembourg ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0836511 CA 2006 00019 Denmark ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1214076 C01214076/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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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.