Mayne Pharma Company Profile
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What is the competitive landscape for MAYNE PHARMA, and what generic alternatives to MAYNE PHARMA drugs are available?
MAYNE PHARMA has fifteen approved drugs.
There are eighty US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.
There are four hundred and sixty-six patent family members on MAYNE PHARMA drugs in fifty-one countries and sixty-one supplementary protection certificates in fourteen countries.
Summary for Mayne Pharma
| International Patents: | 466 |
| US Patents: | 80 |
| Tradenames: | 18 |
| Ingredients: | 14 |
| NDAs: | 15 |
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 | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | 11,964,055 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | LEXETTE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 210566-001 | May 24, 2018 | AB | RX | Yes | Yes | 10,857,159*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-002 | Dec 28, 2021 | RX | Yes | No | 8,987,237 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | RX | Yes | Yes | 8,883,838 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | 7,732,430 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | RX | Yes | No | 9,511,031 | ⤷ Sign Up | Y | ⤷ 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 | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | 6,958,161 | ⤷ Sign Up |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | 8,815,929 | ⤷ Sign Up |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-002 | May 6, 2005 | 6,958,161 | ⤷ Sign Up |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | 6,958,161 | ⤷ Sign Up |
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | 8,771,739 | ⤷ Sign Up |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-003 | Jun 20, 2008 | 6,958,161 | ⤷ 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 |
International Patents for Mayne Pharma Drugs
Supplementary Protection Certificates for Mayne Pharma Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0836511 | SPC/GB06/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 0836511 | 122006000022 | Germany | ⤷ Sign Up | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0398460 | 04C0022 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 0284288 | 12/1998 | Austria | ⤷ Sign Up | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203 |
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| >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.
