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Mayne Pharma Company Profile
What is the competitive landscape for MAYNE PHARMA, and what generic alternatives to MAYNE PHARMA drugs are available?
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 Inc | OXYCODONE AND ACETAMINOPHEN | acetaminophen; oxycodone hydrochloride | TABLET;ORAL | 090177-006 | Oct 20, 2008 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | |||||
| Mayne Pharma | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 076137-003 | Jan 18, 2002 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma Inc | DOXYCYCLINE | doxycycline | CAPSULE;ORAL | 209396-001 | Sep 29, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 200886-001 | Feb 26, 2018 | AB1 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 076137-002 | Jan 18, 2002 | 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 | 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 |
International Patents for Mayne Pharma Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2010096868 | ➤ Sign Up |
| Canada | 2611147 | ➤ Sign Up |
| Canada | 2333869 | ➤ Sign Up |
| Brazil | 9913154 | ➤ Sign Up |
| Australia | 760153 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Mayne Pharma Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| 00C/005 | Belgium | ➤ Sign Up | PRODUCT NAME: DOFETILIDE; REGISTRATION NO/DATE: EU/1/99/121/001 19991129 |
| C0008 | Belgium | ➤ Sign Up | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
| C/GB02/033 | United Kingdom | ➤ Sign Up | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
| 2006 00038 | Denmark | ➤ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 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.
Here is a list of applicants with similar names.
