Tris Pharma Inc Company Profile

What is the competitive landscape for TRIS PHARMA INC

TRIS PHARMA INC has twenty-eight approved drugs.

There are twelve US patents protecting TRIS PHARMA INC drugs.

There are nineteen patent family members on TRIS PHARMA INC drugs in fourteen countries and twenty-eight supplementary protection certificates in ten countries.

Summary for Tris Pharma Inc

International Patents:	19
US Patents:	12
Tradenames:	28
Ingredients:	23
NDAs:	28
Drug Master File Entries:	6

Drugs and US Patents for Tris Pharma Inc

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	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	202214-002	Mar 27, 2013	AA	RX	No	No
Tris Pharma Inc	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	214076-001	Jan 26, 2022		DISCN	No	No
Tris Pharma Inc	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	091632-001	Oct 1, 2010		RX	No	Yes
Tris Pharma Inc	THEOPHYLLINE	theophylline	SOLUTION;ORAL	091586-001	Jun 15, 2012	AA	RX	No	No
Tris Pharma Inc	HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate; hydrocodone bitartrate	SOLUTION;ORAL	206438-001	Jan 27, 2015		DISCN	No	No
Tris Pharma Inc	DYANAVEL XR 5	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-001	Nov 4, 2021		RX	Yes	No	11,590,081		Y

International Patents for Tris Pharma Inc Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2428205
Spain	2396039
China	101400343
Brazil	PI0709606
China	102488652
Israel	194042

Supplementary Protection Certificates for Tris Pharma Inc Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
0463756	SPC/GB99/004	United Kingdom		PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
0463756	C990005	Netherlands		PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622
1539166	60/2013	Austria		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

Similar Applicant Names

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• Tris Pharma Inc

Pharmaceutical Competitive Landscape Analysis: TRIS PHARMA INC – Market Position, Strengths & Strategic Insights

Last updated: February 12, 2025

Tris Pharma Inc. has emerged as a significant player in the pharmaceutical industry, particularly in the development and commercialization of innovative medicines for unmet patient needs. This analysis delves into Tris Pharma's market position, strengths, and strategic insights, providing a comprehensive overview of the company's competitive landscape.

Company Overview

Tris Pharma is a privately-owned biopharmaceutical company based in the United States. The company focuses on developing and commercializing innovative medicines that address unmet patient needs, particularly in neuroscience and other therapeutic categories[6]. With a robust portfolio of FDA-approved products and a strong pipeline of innovative candidates, Tris Pharma has established itself as a leader in the pharmaceutical industry.

Key Facts

• Founded: Not specified in the search results
• Headquarters: Monmouth Junction, New Jersey
• Employees: Approximately 500
• Focus Areas: ADHD and related disorders, neuroscience, and other therapeutic categories
• Patents: More than 150 U.S. and International patents including applications[6]

Product Portfolio and Pipeline

Tris Pharma's product portfolio includes both branded and generic products, with a particular focus on ADHD treatments. The company has successfully developed and commercialized several innovative medications that offer unique benefits to patients.

ADHD Medications

Tris Pharma has established a strong presence in the ADHD market with its FDA-approved products:

1. Quillivant XR: A long-acting, once-daily liquid methylphenidate formulation
2. Quillichew ER: A long-acting, once-daily chewable methylphenidate formulation[7]

These products address specific challenges faced by ADHD patients, particularly younger individuals who may have difficulty swallowing pills or require customized dosing options.

Generic Products

In addition to its branded portfolio, Tris Pharma has a robust generics division focused on creating high-quality, patient-friendly products. The company is a market leader in many of its product categories and has a pipeline of 20+ generic products in development[2].

Pipeline and Innovation

Tris Pharma's commitment to innovation is evident in its robust pipeline of products. The company has several ANDAs and two NDAs pending FDA approval[1]. This pipeline positions Tris Pharma for future growth and demonstrates its ongoing commitment to addressing unmet medical needs.

Manufacturing Capabilities and Expansion

Tris Pharma has been actively expanding its manufacturing capabilities to support its growing product portfolio and pipeline.

Recent Expansion

In July 2023, Tris Pharma announced a significant expansion of its manufacturing capacity:

• Initiated a 15-month expansion project
• Current footprint: 90,000 sq. ft.
• Projected footprint after expansion: Approximately 200,000 sq. ft.
• First phase expected to double cGMP capacity[1]

This expansion is crucial for Tris Pharma to meet the increasing demand for its products and support its growth trajectory.

Strategic Partnerships and Collaborations

Tris Pharma has demonstrated a strategic approach to partnerships and collaborations, which has been instrumental in expanding its market reach and enhancing its product offerings.

Neuraxpharm Group Partnership

In December 2020, Tris Pharma announced a partnership with Neuraxpharm Group, a leading European specialty pharmaceutical company focused on CNS:

• Neuraxpharm received exclusive rights to commercialize Quillivant XR and Quillichew ER in Europe
• This partnership expands Tris Pharma's reach into the European market, one of the largest pharmaceutical markets globally[7]

"As one of the largest pharmaceutical markets in the world, Europe has been a high priority for Tris as we continue to strive to make our differentiated product portfolio available to patients globally," said Ketan Mehta, Tris' Founder and CEO[7].

This partnership highlights Tris Pharma's strategy of leveraging strategic collaborations to expand its global footprint and maximize the value of its innovative products.

Leadership and Management

Tris Pharma has been strengthening its leadership team to support its growth and expansion strategies.

Recent Appointments

In May 2023, Tris Pharma announced two key appointments to its leadership team:

1. Thomas Englese: Appointed as Chief Commercial Officer
2. Marc Lesnick, Ph.D.: Appointed as Chief Development Officer[4][8]

These appointments reflect Tris Pharma's commitment to enhancing its commercial success and advancing its clinical pipeline.

Scientific Advisory Board

In October 2020, Tris Pharma launched its Scientific Advisory Board (SAB). The purpose of the SAB is to help the company achieve its emerging clinical research and product development pipeline goals[9]. This initiative demonstrates Tris Pharma's commitment to scientific excellence and its focus on advancing innovative therapies.

Market Position and Competitive Landscape

Tris Pharma operates in a highly competitive pharmaceutical landscape, particularly in the generics and specialty pharmaceutical sectors. While specific market share data for Tris Pharma is not provided in the search results, we can infer its competitive position based on available information.

Strengths

1. Innovative ADHD Therapies: Tris Pharma's unique formulations of methylphenidate (Quillivant XR and Quillichew ER) provide a competitive edge in the ADHD market[7].

2. Robust Generic Portfolio: The company is a market leader in many of its product categories within the generics space[2].

3. Strong Pipeline: With several ANDAs and NDAs pending approval, Tris Pharma is well-positioned for future growth[1].

4. Manufacturing Expansion: The ongoing expansion of manufacturing capacity demonstrates Tris Pharma's commitment to meeting market demand and supporting growth[1].

5. Strategic Partnerships: Collaborations like the one with Neuraxpharm Group enable Tris Pharma to expand its global reach[7].

Competitive Landscape

While Tris Pharma has established a strong position in certain niche markets, it faces competition from larger pharmaceutical companies, particularly in the generics space. Some key competitors in the generics market include:

• Teva
• Mylan (Viatris)
• Sandoz (Novartis)
• Sun Pharma[10]

These companies have significant market presence and resources, which could pose challenges for Tris Pharma in certain market segments.

Strategic Insights and Future Outlook

Based on the available information, we can identify several key strategic insights for Tris Pharma:

1. Focus on Differentiated Products: Tris Pharma's success with innovative ADHD formulations suggests that continuing to develop unique, patient-friendly products could be a key growth driver.

2. Expansion of Manufacturing Capacity: The ongoing expansion project indicates that Tris Pharma is preparing for increased demand and potential new product launches.

3. Strategic Partnerships: Collaborations like the one with Neuraxpharm Group can help Tris Pharma expand its global reach and maximize the value of its product portfolio.

4. Investment in R&D: The robust pipeline and establishment of a Scientific Advisory Board demonstrate Tris Pharma's commitment to ongoing innovation.

5. Strengthening Leadership: Recent appointments to the leadership team suggest that Tris Pharma is positioning itself for growth and expansion.

Key Takeaways

• Tris Pharma has established a strong position in the ADHD market with innovative formulations.
• The company's generics division is a market leader in several product categories.
• Ongoing manufacturing expansion and a robust pipeline position Tris Pharma for future growth.
• Strategic partnerships are enabling global expansion and market penetration.
• Investment in R&D and leadership strengthening demonstrate a commitment to long-term growth and innovation.

While Tris Pharma faces competition from larger pharmaceutical companies, its focus on innovation, strategic partnerships, and manufacturing expansion provide a solid foundation for continued growth and market presence.

FAQs

1. What are Tris Pharma's main product offerings? Tris Pharma's main product offerings include ADHD medications such as Quillivant XR and Quillichew ER, as well as a range of generic products across various therapeutic categories.

2. How is Tris Pharma expanding its manufacturing capabilities? Tris Pharma is undergoing a 15-month expansion project that will increase its manufacturing footprint from 90,000 sq. ft. to approximately 200,000 sq. ft., with the first phase expected to double cGMP capacity.

3. What strategic partnerships has Tris Pharma formed recently? One significant partnership is with Neuraxpharm Group, which gives Neuraxpharm exclusive rights to commercialize Tris Pharma's ADHD medications in Europe.

4. How does Tris Pharma support innovation in product development? Tris Pharma supports innovation through ongoing R&D efforts, a robust product pipeline, and the establishment of a Scientific Advisory Board to guide clinical research and product development.

5. What are the key competitive advantages of Tris Pharma? Key competitive advantages include innovative ADHD formulations, a strong generics portfolio, expanding manufacturing capabilities, strategic partnerships for global reach, and a commitment to ongoing R&D and innovation.

Sources cited:

1. https://www.trispharma.com/tris-pharma-expands-manufacturing-capacity-and-strengthens-supply-chain-to-support-new-and-pending-approvals/
2. https://staging.trispharma.com/our-focus/generics/
3. https://www.biospace.com/tris-pharma-expands-leadership-team-as-company-broadens-commercial-portfolio-and-progresses-clinical-pipeline
4. https://leadiq.com/c/tris-pharma/5a1d8a5e240000240063a46c
5. https://www.trispharma.com/tris-pharma-and-neuraxpharm-group-announce-partnership-to-commercialize-tris-quillivant-xr-and-quillichew-er-in-europe/
6. https://www.businesswire.com/news/home/20230502005475/en/Tris-Pharma-Expands-Leadership-Team-as-Company-Broadens-Commercial-Portfolio-and-Progresses-Clinical-Pipeline
7. https://www.trispharma.com/tris-pharma-launches-its-scientific-advisory-board/
8. https://umbrex.com/resources/industry-analyses/how-to-analyze-a-pharmaceutical-company/generics-portfolio-strength-and-market-share/