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Serving 500+ biopharmaceutical companies globally:
Generated: August 18, 2017
What is the competitive landscape for TRIS PHARMA INC, and what generic alternatives to TRIS PHARMA INC drugs are available?
TRIS PHARMA INC has twenty-five approved drugs.| Patents: | 6 |
| Tradenames: | 24 |
| Ingredients: | 23 |
| NDAs: | 25 |
| Drug Master File Entries: (click here to view) | 5 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Tris Pharma Inc | DYANAVEL XR | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Tris Pharma Inc | CLONIDINE | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500-002 | Dec 3, 2009 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Tris Pharma Inc | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 202214-001 | Mar 27, 2013 | AA | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Tris Pharma Inc | DYANAVEL XR | amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Tris Pharma Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | SOLUTION;ORAL | 091601-002 | Jul 23, 2010 | AA | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,549,989 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 8,202,537 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 8,491,935 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 9,675,704 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 8,337,890 | Modified release formulations containing drug-ion exchange resin complexes | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2007227569 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 2018160 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2435569 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0709606 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20080108520 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013 00059 | Denmark | ► Subscribe | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 | ||||||||||||||||||||||||||
| C0055 | France | ► Subscribe | PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220 | ||||||||||||||||||||||||||
| 00C/032 | Belgium | ► Subscribe | PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329 | ||||||||||||||||||||||||||
| 00028 | Netherlands | ► Subscribe | PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929 | ||||||||||||||||||||||||||
| C/GB12/028 | United Kingdom | ► Subscribe | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209 | ||||||||||||||||||||||||||
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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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