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 |
| 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 | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | 10,888,516 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | AB | RX | Yes | No | 8,715,724 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | 10,537,581 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-002 | May 6, 2005 | DISCN | Yes | No | 8,715,724 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | 11,116,717 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 8,993,548 | ⤷ 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 Commrcl | SOLTAMOX | tamoxifen citrate | SOLUTION;ORAL | 021807-001 | Oct 29, 2005 | 6,127,425 | ⤷ 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 | 050795-002 | May 6, 2005 | 6,958,161 | ⤷ Sign Up |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-004 | Apr 11, 2013 | 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 | 050795-001 | May 6, 2005 | 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 |
|---|---|---|---|---|
| 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 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 0383579 | C960030 | Netherlands | ⤷ Sign Up | PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517 |
| 2782584 | 132021000000197 | Italy | ⤷ Sign Up | PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517 |
| 0584952 | 99C0004 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
| 1453521 | C 2015 029 | Romania | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
| >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.
