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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 seventy approved drugs.
There are thirteen US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.
There are seventy-two patent family members on MAYNE PHARMA drugs in twenty-two countries and fifty-four supplementary protection certificates in twelve countries.
Summary for Mayne Pharma
| International Patents: | 72 |
| US Patents: | 13 |
| Tradenames: | 67 |
| Ingredients: | 50 |
| NDAs: | 70 |
| 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 | AMIODARONE HYDROCHLORIDE | amiodarone hydrochloride | TABLET;ORAL | 075389-002 | Dec 28, 2017 | AB | RX | No | No | Start Trial | Start Trial | ||||
| Mayne Pharma | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 200407-001 | Oct 25, 2011 | AB | RX | No | No | Start Trial | Start Trial | ||||
| 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 | Start Trial | Start Trial | ||||
| Mayne Pharma Intl | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | 9,713,642 | Start Trial | Start Trial | ||||
| Mayne Pharma Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 207058-002 | Jun 6, 2016 | AB | RX | No | No | Start Trial | Start 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 | TRI-NORINYL 21-DAY | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018977-001 | Apr 13, 1984 | 4,390,531 | Start Trial |
| Mayne Pharma | TRI-NORINYL 28-DAY | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 018977-002 | Apr 13, 1984 | 4,390,531 | Start 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 | 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 |
| ➤ Subscribe | Delayed-release Tablets | 200 mg | ➤ Subscribe | 2013-08-12 |
| ➤ Subscribe | Delayed-release Tablets | 80 mg | ➤ Subscribe | 2015-07-01 |
International Patents for Mayne Pharma Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1239831 | Start Trial |
| Japan | 5159012 | Start Trial |
| Spain | 2447301 | Start Trial |
| South Korea | 101725196 | Start Trial |
| Japan | 6130992 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Mayne Pharma Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0770388 | PA2009004 | Lithuania | Start 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 |
| 1380301 | CA 2009 00017 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 0398460 | 12/2004 | Austria | Start Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 1453521 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1214076 | 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| >Patent Number | >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.
