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 |
| 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 | 208564-001 | May 29, 2018 | RX | Yes | No | 10,668,082 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-001 | May 29, 2018 | RX | Yes | No | 9,180,091 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | 10,398,708 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | RX | Yes | No | 9,295,652 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 8,993,549 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mayne Pharma Inc | HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE | hydrocodone bitartrate; pseudoephedrine hydrochloride | SOLUTION;ORAL | 205658-001 | Nov 17, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 11,033,626 | ⤷ 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 |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | 8,420,688 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for MAYNE PHARMA Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2861234 | ⤷ Sign Up |
| Austria | 320259 | ⤷ Sign Up |
| European Patent Office | 3986375 | ⤷ Sign Up |
| Chile | 2021003410 | ⤷ Sign Up |
| Mexico | 2018007343 | ⤷ Sign Up |
| Denmark | 3701944 | ⤷ Sign Up |
| Cuba | 20170161 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MAYNE PHARMA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1453521 | C201630040 | Spain | ⤷ Sign Up | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
| 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 |
| 1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| 0770388 | 2009/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
| 0770388 | 9/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| 0770388 | SPC/GB09/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
| >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.
