DrugPatentWatch Database Preview
Mayne Pharma Company Profile
What is the competitive landscape for MAYNE PHARMA, and when can generic versions of MAYNE PHARMA drugs launch?
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: | 61 |
| Ingredients: | 44 |
| NDAs: | 64 |
| 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 | 075389-003 | Dec 28, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | CLARITHROMYCIN | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 065154-001 | May 18, 2005 | AB | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | LEVORA 0.15/30-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 073594-001 | Dec 13, 1993 | AB | RX | No | Yes | ➤ Sign Up | ➤ Sign Up | ||||
| Mayne Pharma | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 077681-001 | May 31, 2006 | AB2 | RX | No | Yes | ➤ 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 |
|---|---|---|
| 2,016,151,395 | ➤ Sign Up | |
| 6,730,288 | Mousse composition | ➤ Sign Up |
| 8,298,515 | Vitamin formulation | ➤ 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 |
|---|---|---|
| China | 102438590 | ➤ Sign Up |
| Japan | 2008542353 | ➤ Sign Up |
| Eurasian Patent Organization | 020844 | ➤ Sign Up |
| European Patent Office | 1917072 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Mayne Pharma Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2006000022 | Germany | ➤ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 00221 | Netherlands | ➤ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 00523 | Netherlands | ➤ Sign Up | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| C0005 | Belgium | ➤ Sign Up | PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711 |
| 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.
