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Last Updated: April 24, 2024

Mayne Pharma Company Profile


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Summary for Mayne Pharma
International Patents:425
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 BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 11,110,099 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes 11,116,717 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes 10,471,072 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-006 Dec 19, 2014 DISCN Yes No 8,715,724 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No 10,668,082 ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 DISCN Yes No 9,446,057 ⤷  Try a Trial Y ⤷  Try a Trial
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 10,206,932 ⤷  Try a Trial ⤷  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 DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 6,958,161 ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-001 May 6, 2005 6,958,161 ⤷  Try a Trial
Mayne Pharma TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 8,771,739 ⤷  Try a Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 6,958,161 ⤷  Try a Trial
Mayne Pharma RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552-001 Jan 18, 2017 8,815,929 ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-005 Apr 11, 2013 6,958,161 ⤷  Try a Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-004 Apr 11, 2013 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 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
2782584 2021C/558 Belgium ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--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 20210406
0402407 97C0005 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
0770388 PA2009004,C0770388 Lithuania ⤷  Try a 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
0334429 97C0002 Belgium ⤷  Try a Trial PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0284288 SPC/GB98/002 United Kingdom ⤷  Try a Trial PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0383579 C960030 Netherlands ⤷  Try a Trial 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
3632448 22C1031 France ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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