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Serving leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
Colorcon
Federal Trade Commission
QuintilesIMS
Chinese Patent Office
Medtronic
Moodys
Julphar
Novartis

Generated: February 22, 2018

DrugPatentWatch Database Preview

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 sixty-four approved drugs.

There are eight US patents protecting MAYNE PHARMA drugs and there have been three Paragraph IV challenges on MAYNE PHARMA drugs in the past three years.

There are forty-five patent family members on MAYNE PHARMA drugs in nineteen countries and forty-seven supplementary protection certificates in eleven countries.

Summary for Mayne Pharma
International Patents:45
US Patents:8
Tradenames:59
Ingredients:42
NDAs:64

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 DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-001 May 6, 2005 AB RX Yes No 6,958,161 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No 6,958,161 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mayne Pharma TRIVORA-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 074538-001 Dec 18, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma CLOZAPINE clozapine TABLET;ORAL 203807-001 Sep 17, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313-001 Feb 18, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-001 Jan 25, 2001 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 208765-002 Jun 14, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma DIAZEPAM diazepam TABLET;ORAL 071135-001 Feb 3, 1987 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma ESTRADIOL estradiol TABLET;ORAL 040114-002 Mar 14, 1996 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma Inc AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 075389-002 Dec 28, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial
Mayne Pharma TRI-NORINYL 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 018977-002 Apr 13, 1984 4,390,531 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MAYNE PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 60 mg and 120 mg ➤ Subscribe 9/28/2017
➤ Subscribe Delayed-release Tablets 50 mg ➤ Subscribe 11/5/2015
➤ Subscribe Delayed-release Tablets 80 mg ➤ Subscribe 7/1/2015
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe 5/19/2014
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe 8/12/2013
➤ Subscribe Delayed-release Tablets 150 mg ➤ Subscribe 12/19/2008

Non-Orange Book US Patents for Mayne Pharma

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,730,288 Mousse composition ➤ Try a Free Trial
2,016,151,395 ➤ Try a Free Trial
7,029,659 Mousse composition ➤ Try a Free Trial
8,298,515 Vitamin formulation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for Mayne Pharma Drugs

Supplementary Protection Certificates for Mayne Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009004,C0770388 Lithuania ➤ Try a Free 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
0653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2006 00019 Denmark ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORID
09/012 Ireland ➤ Try a Free Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2015000093 Germany ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011/03 Switzerland ➤ Try a Free Trial PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
2011000009 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
C0022 France ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2016 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00521 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Farmers Insurance
Chinese Patent Office
Covington
Boehringer Ingelheim
Daiichi Sankyo
Federal Trade Commission
Merck
Express Scripts

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 verifification 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.

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