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Generated: July 21, 2017
What is the competitive landscape for MAYNE PHARMA, and when can generic versions of MAYNE PHARMA drugs launch?
MAYNE PHARMA has sixty-five approved drugs.| Patents: | 8 |
| Tradenames: | 58 |
| Ingredients: | 41 |
| NDAs: | 65 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mayne Pharma | NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | CAPSULE;ORAL | 073553-001 | Mar 30, 1992 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mayne Pharma | CLOZAPINE | clozapine | TABLET;ORAL | 203807-001 | Sep 17, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mayne Pharma Inc | DOFETILIDE | dofetilide | CAPSULE;ORAL | 207058-001 | Jun 6, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mayne Pharma | DORYX MPC | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 050795-008 | May 20, 2016 | RX | Yes | Yes | 9,511,031 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Mayne Pharma | DIAZEPAM | diazepam | TABLET;ORAL | 071134-001 | Feb 3, 1987 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mayne Pharma | TRI-NORINYL 21-DAY | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018977-001 | Apr 13, 1984 | 4,390,531 | ► Subscribe | ||||||||||||||||||||||
Mayne Pharma | TRI-NORINYL 28-DAY | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 018977-002 | Apr 13, 1984 | 4,390,531 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
doxycycline hyclate | Delayed-release Tablets | 50 mg | DORYX | 11/5/2015 |
doxycycline hyclate | Delayed-release Tablets | 80 mg | DORYX | 7/1/2015 |
doxycycline hyclate | Delayed-release Tablets | 200 mg | DORYX | 5/19/2014 |
doxycycline hyclate (as of 6/10/14) | Delayed-release Tablets | 200 mg | DORYX | 8/12/2013 |
doxycycline hyclate | Delayed-release Tablets | 150 mg | DORYX | 12/19/2008 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,730,288 | Mousse composition | ► Subscribe | |||||||||||||||||||||||||||
| 2,016,151,395 | ► Subscribe | ||||||||||||||||||||||||||||
| 8,298,515 | Vitamin formulation | ► Subscribe | |||||||||||||||||||||||||||
| 7,029,659 | Mousse composition | ► Subscribe | |||||||||||||||||||||||||||
| 8,991,390 | Inhalation device and method | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Zealand | 508259 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2006253913 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2012518662 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2784041 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1872776 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0005 | Belgium | ► Subscribe | PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711 | ||||||||||||||||||||||||||
| 00C/027 | Belgium | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 | ||||||||||||||||||||||||||
| C0008 | Belgium | ► Subscribe | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107 | ||||||||||||||||||||||||||
| 2006 00038 | Denmark | ► Subscribe | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 | ||||||||||||||||||||||||||
| C0004 | Belgium | ► Subscribe | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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