MAYNE PHARMA Company Profile
✉ Email this page to a colleague
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 seventy-eight US patents protecting MAYNE PHARMA drugs. There is one tentative approval on MAYNE PHARMA drugs.
There are four hundred and twenty-five patent family members on MAYNE PHARMA drugs in forty-nine countries and sixty supplementary protection certificates in fourteen countries.
Summary for MAYNE PHARMA
| International Patents: | 425 |
| US Patents: | 78 |
| 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 | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | RX | Yes | No | 9,511,031 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mayne Pharma | SORILUX | calcipotriene | AEROSOL, FOAM;TOPICAL | 022563-001 | Oct 6, 2010 | RX | Yes | Yes | 8,263,580 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | 9,006,222 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | 10,888,516 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mayne Pharma | FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077062-004 | Aug 20, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| >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 | 050795-003 | Jun 20, 2008 | 6,958,161 | ⤷ Try a Trial |
| Mayne Pharma | DORYX | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-005 | Apr 11, 2013 | 6,958,161 | ⤷ Try a Trial |
| Mayne Pharma | TOLSURA | itraconazole | CAPSULE;ORAL | 208901-001 | Dec 11, 2018 | 8,771,739 | ⤷ Try a Trial |
| Mayne Pharma | RHOFADE | oxymetazoline hydrochloride | CREAM;TOPICAL | 208552-001 | Jan 18, 2017 | 8,815,929 | ⤷ Try a Trial |
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-007 | May 20, 2016 | 6,958,161 | ⤷ Try a Trial |
| Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-008 | May 20, 2016 | 6,958,161 | ⤷ Try a Trial |
| >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 |
|---|---|---|
| Montenegro | 03728 | ⤷ Try a Trial |
| Russian Federation | 2740059 | ⤷ Try a Trial |
| Spain | 2796871 | ⤷ Try a Trial |
| Mexico | 2014015897 | ⤷ Try a Trial |
| Australia | 2013277233 | ⤷ Try a Trial |
| Brazil | 112014031824 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MAYNE PHARMA Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0284288 | 12/1998 | Austria | ⤷ Try a Trial | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203 |
| 1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1214076 | SZ 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 1453521 | 132016000025143 | Italy | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| 0770388 | PA2009004 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
| 2782584 | 21C1058 | France | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
| >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.
