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Mayne Pharma Company Profile
What is the competitive landscape for MAYNE PHARMA, and when can generic versions of MAYNE PHARMA drugs launch?
MAYNE PHARMA has sixty-five approved drugs.
There are eight US patents protecting MAYNE PHARMA drugs.
There are forty-five patent family members on MAYNE PHARMA drugs in nineteen countries and forty-eight supplementary protection certificates in eleven countries.
Summary for Mayne Pharma
| International Patents: | 45 |
| US Patents: | 8 |
| Tradenames: | 62 |
| Ingredients: | 45 |
| NDAs: | 65 |
| 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 | DIAZEPAM | diazepam | TABLET;ORAL | 071134-001 | Feb 3, 1987 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma Inc | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | CAPSULE;ORAL | 207313-001 | Dec 27, 2017 | RX | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Mayne Pharma Inc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | CAPSULE;ORAL | 203107-001 | Jul 26, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | DISCN | Yes | No | 8,715,724 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Mayne Pharma | FENTANYL-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077062-001 | Aug 20, 2007 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | ➤ Sign Up |
| Mayne Pharma | TRI-NORINYL 28-DAY | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 018977-002 | Apr 13, 1984 | 4,390,531 | ➤ Sign Up |
| 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 |
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 | ➤ Sign Up |
| 8,298,515 | Vitamin formulation | ➤ Sign Up |
| 2,016,151,395 | ➤ Sign Up | |
| 7,029,659 | Mousse composition | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Mayne Pharma Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 6182191 | ➤ Sign Up |
| South Korea | 20110138353 | ➤ Sign Up |
| Spain | 2447301 | ➤ Sign Up |
| Eurasian Patent Organization | 201171079 | ➤ Sign Up |
| Denmark | 1112062 | ➤ Sign Up |
| Brazil | PI1008037 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Mayne Pharma Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014000024 | Germany | ➤ Sign Up | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
| 2014 00016 | Denmark | ➤ Sign Up | PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831 |
| 00002 | Netherlands | ➤ Sign Up | PRODUCT NAME: DOFETILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/99/121/001 - EU/1/99/121/015 19991129 |
| C0021 | Belgium | ➤ Sign Up | 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 |
| C0004 | Belgium | ➤ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
| C/GB00/005 | United Kingdom | ➤ Sign Up | PRODUCT NAME: DOFETILIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/99/121/001 19991129; UK EU/1/99/121/002 19991129; UK EU/1/99/121/003 19991129; UK EU/1/99/121/004 19991129; UK EU/1/99/121/005 19991129; UK EU/1/99/121/006 19991129; UK EU/1/99/121/007 19991129; UK EU/1/99/121/008 19991129; UK EU/1/99/121/009 19991129; UK EU/1/99/121/010 19991129; UK EU/1/99/121/011 19991129; UK EU/1/99/121/012 19991129; UK EU/1/99/121/013 19991129; UK EU/1/99/121/014 19991129; UK EU/1/99/121/015 19991129 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.
