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 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 | LEXETTE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 210566-001 | May 24, 2018 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 9,114,146 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | RX | Yes | Yes | 8,921,374 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | 11,065,197 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 8,993,548 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Mayne Pharma | FENTANYL-50 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077062-002 | Aug 20, 2007 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| >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 | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | 8,815,929 | ⤷ Subscribe |
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | 8,771,739 | ⤷ Subscribe |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-002 | May 6, 2005 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-008 | May 20, 2016 | 6,958,161 | ⤷ Subscribe |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-003 | Jun 20, 2008 | 6,958,161 | ⤷ Subscribe |
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20180021085 | ⤷ Subscribe |
| Portugal | 1293210 | ⤷ Subscribe |
| European Patent Office | 2526930 | ⤷ Subscribe |
| New Zealand | 727233 | ⤷ Subscribe |
| Croatia | P20180889 | ⤷ Subscribe |
| Japan | 2018521985 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MAYNE PHARMA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0031058 | 98C0008 | Belgium | ⤷ Subscribe | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
| 0398460 | 12/2004 | Austria | ⤷ Subscribe | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 2782584 | C202130068 | Spain | ⤷ Subscribe | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
| 1214076 | 49/2008 | Austria | ⤷ Subscribe | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 0901368 | C300523 | Netherlands | ⤷ Subscribe | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
| 3632448 | LUC00266 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
| >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.
