Last Updated: November 9, 2026

Tris Pharma Inc Company Profile

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What is the competitive landscape for TRIS PHARMA INC

TRIS PHARMA INC has twenty-eight approved drugs.

There are fifteen US patents protecting TRIS PHARMA INC drugs.

Summary for Tris Pharma Inc

US Patents:	15
Tradenames:	29
Ingredients:	24
NDAs:	28

Drugs and US Patents for Tris Pharma Inc

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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 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	12,734,132	⤷ Start Trial				⤷ Start Trial
Tris Pharma Inc	DYANAVEL XR 20	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-004	Nov 4, 2021		RX	Yes	Yes	12,458,592	⤷ Start Trial				⤷ Start Trial
Tris Pharma Inc	ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645-001	May 24, 2024		RX	Yes	Yes	8,062,667	⤷ Start Trial	Y			⤷ Start Trial
Tris Pharma Inc	TUZISTRA XR	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	207768-001	Apr 30, 2015		DISCN	Yes	No	8,790,700	⤷ Start Trial	Y			⤷ Start Trial
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes	11,590,228	⤷ Start Trial	Y			⤷ Start Trial
Tris Pharma Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	202214-003	Mar 27, 2013	AA	RX	No	No		⤷ Start Trial				⤷ Start Trial
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	12,734,132	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Paragraph IV (Patent) Challenges for TRIS PHARMA INC drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	250 mcg/0.5 mL, 1 mL PFS	➤ Subscribe	2012-03-30

International Patents for Tris Pharma Inc Drugs

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Country	Patent Number	Estimated Expiration
Denmark	2428205	⤷ Start Trial
Austria	E536867	⤷ Start Trial
Denmark	2018160	⤷ Start Trial
Russian Federation	2008140944	⤷ Start Trial
Israel	194042	⤷ Start Trial
Denmark	2428205	⤷ Start Trial
Austria	E536867	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Tris Pharma Inc Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	60/2013	Austria	⤷ Start Trial	PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
0463756	5/1999	Austria	⤷ Start Trial	PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
0733366	SPC/GB98/031	United Kingdom	⤷ Start Trial	PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0641330	SPC/GB04/034	United Kingdom	⤷ Start Trial	PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
1539166	92323	Luxembourg	⤷ Start Trial	PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
0934061	PA2004017,C0934061	Lithuania	⤷ Start Trial	PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
1539166	2013/055	Ireland	⤷ Start Trial	PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Tris Pharma Inc

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.