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TREXIMET Drug Patent Profile

When do Treximet patents expire, and when can generic versions of Treximet launch?

Treximet is a drug marketed by Currax and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Treximet

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TREXIMET

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	22
Drug Prices:	Drug price information for TREXIMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREXIMET
What excipients (inactive ingredients) are in TREXIMET?	TREXIMET excipients list
DailyMed Link:	TREXIMET at DailyMed

See drug prices for TREXIMET

Recent Clinical Trials for TREXIMET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dent Neurologic Institute	N/A
Premiere Research Institute	Phase 2/Phase 3
GlaxoSmithKline	Phase 2/Phase 3

See all TREXIMET clinical trials

Pharmacology for TREXIMET

Drug Class	Nonsteroidal Anti-inflammatory Drug Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Paragraph IV (Patent) Challenges for TREXIMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TREXIMET	Tablets	naproxen sodium; sumatriptan succinate	500 mg/85 mg	021926	1	2008-07-23

US Patents and Regulatory Information for TREXIMET

TREXIMET is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No					Y
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes					Y

Expired US Patents for TREXIMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008

International Patents for TREXIMET

See the table below for patents covering TREXIMET around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	351185
Austria	546134
Philippines	22850	INDOLE DERIVATIVES
Netherlands	930065

Supplementary Protection Certificates for TREXIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

TREXIMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Treximet

Introduction to Treximet

Treximet, a combination of sumatriptan and naproxen sodium, is a prescription medication used for the acute treatment of migraine attacks with or without aura in adults. Here, we will delve into the market dynamics and financial trajectory of Treximet, particularly focusing on its acquisition by Pernix Therapeutics and subsequent performance.

Acquisition by Pernix Therapeutics

In August 2014, Pernix Therapeutics acquired the U.S. rights to Treximet from GlaxoSmithKline (GSK) for an upfront payment of $250 million. This acquisition was a significant step in Pernix's strategy to expand its portfolio within the Central Nervous System (CNS) market, alongside other brands like Silenor and Khedezla[1].

Market Positioning and Sales Strategy

Pernix supported the sales of Treximet with a team of approximately 100 specialty sales professionals, targeting neurology and primary care audiences. The company took advantage of the minimal competition in a promotionally sensitive market, which helped in the successful re-launch of Treximet[1][2].

Financial Impact of the Acquisition

The acquisition of Treximet significantly boosted Pernix Therapeutics' financial performance. For the third quarter of 2014, net revenues increased by 72% to $31.5 million, largely driven by the inclusion of Treximet. Gross profit for the quarter increased by 127% to $19.8 million, and gross margins improved to 62.9% compared to 47.7% in the prior year[2].

Revenue and EBITDA Projections

Following the acquisition, Pernix estimated its FY 2014 revenue to be in the range of $110 million to $120 million, with Adjusted EBITDA of $22 million to $24 million. For FY 2015, the company projected revenue of approximately $230 million and Adjusted EBITDA of around $95 million[1].

Performance in Subsequent Years

In the fourth quarter of 2014, net sales were $53.8 million, a 125% increase from the prior year, driven by the strong performance of Treximet. For the full year 2014, net sales increased by 43% to $121.7 million compared to 2013[5].

Life-Cycle Management and Pediatric Indication

Pernix pursued additional life-cycle opportunities for Treximet, including seeking an extension of exclusivity for a pediatric indication (ages 12 to 17). The company submitted data to the FDA and received approval to market Treximet for pediatric patients in October 2016[1][3].

Manufacturing and Supply Agreement

Treximet is manufactured by GSK under a supply agreement with Pernix. Pernix pays royalties of 18% of net sales to GSK, with quarterly minimum royalty amounts of $4 million from January 1, 2015, to March 31, 2018[1].

Generic Competition and Authorized Generic

By 2018, several companies filed abbreviated new drug applications (ANDAs) for generic versions of Treximet. Despite this, Pernix intended to launch its own authorized generic in early 2018 to maintain market presence. The company faced some revenue impact due to generic competition, but the authorized generic helped mitigate this effect[3].

Market Trends in Migraine Therapeutics

The migraine therapeutics market, particularly the triptans segment, is expected to grow due to the higher efficacy of triptans like Treximet. North America, with its high prevalence of migraine and adoption of novel therapeutics, is expected to dominate the market[4].

Financial Challenges and Adjustments

Pernix faced financial adjustments due to an arbitration award with GSK, which affected the net revenues of Treximet. For instance, in 2016, net revenues were negatively impacted by $15.3 million due to disputed rebate claims related to prior sales periods[3].

Key Financial Metrics

• Net Sales: For the years ended December 31, 2015, and 2016, net revenues of Treximet were $101.8 million and $67.0 million, respectively[3].
• Gross Profit: Gross profit increased significantly with the inclusion of Treximet, reaching $39.0 million in the fourth quarter of 2014[5].
• Adjusted EBITDA: Adjusted EBITDA improved substantially, from a loss of $2.0 million in Q3 2013 to a gain of $6.9 million in Q3 2014[2].

Conclusion

The acquisition of Treximet by Pernix Therapeutics marked a significant milestone in the company's growth within the CNS market. Despite facing challenges from generic competition and financial adjustments, Treximet's strong market performance and strategic life-cycle management initiatives contributed to Pernix's financial growth and market positioning.

Key Takeaways

• Acquisition Impact: The acquisition of Treximet significantly boosted Pernix Therapeutics' revenue and EBITDA.
• Market Positioning: Treximet was successfully re-launched with a focused sales strategy targeting neurology and primary care audiences.
• Life-Cycle Management: Pernix pursued pediatric indication and other life-cycle opportunities to extend Treximet's market life.
• Financial Performance: Net sales and gross profit saw substantial increases following the acquisition.
• Market Trends: The triptans segment, including Treximet, is expected to grow due to higher efficacy and new product launches.

FAQs

Q: What is Treximet used for? A: Treximet is used for the acute treatment of migraine attacks with or without aura in adults.

Q: Who acquired the U.S. rights to Treximet? A: Pernix Therapeutics acquired the U.S. rights to Treximet from GlaxoSmithKline (GSK) in August 2014.

Q: How did the acquisition impact Pernix Therapeutics' financials? A: The acquisition significantly increased Pernix's net revenues, gross profit, and Adjusted EBITDA.

Q: What life-cycle management initiatives did Pernix pursue for Treximet? A: Pernix sought an extension of exclusivity for a pediatric indication and planned to launch its own authorized generic.

Q: How has generic competition affected Treximet's sales? A: Generic competition impacted Treximet's sales, but Pernix's authorized generic helped mitigate this effect.

Cited Sources

1. Pernix Therapeutics Closes on Acquisition of Treximet. Raises $220m Senior Notes. Issues Updated 2014 Guidance.

   • Morristown, NJ, August 19, 2014 – Pernix Therapeutics Holdings, Inc.[1]

2. Pernix Therapeutics Reports Third Quarter 2014 Financial Results and Reaffirms Guidance

   • MORRISTOWN, N.J.--(BUSINESS WIRE)--Pernix Therapeutics Holdings, Inc.[2]

3. FORM 10-K Pernix Therapeutics Holdings, Inc.

   • 2017-03-28[3]

4. Global Migraine Therapeutics Market Trends

   • Mordor Intelligence[4]

5. Pernix Therapeutics Reports Fourth Quarter and 2014 Financial Results and Business Update

   • Business Wire[5]