TROXYCA ER Drug Patent Profile

Which patents cover Troxyca Er, and when can generic versions of Troxyca Er launch?

Troxyca Er is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.

This drug has sixteen patent family members in twelve countries.

The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Troxyca Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 3, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TROXYCA ER

International Patents:	16
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	5
DailyMed Link:	TROXYCA ER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TROXYCA ER

NDA:

207621

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for TROXYCA ER

TROXYCA ER is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No			Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No			Y

International Patents for TROXYCA ER

See the table below for patents covering TROXYCA ER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004026283
European Patent Office	2422773	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
European Patent Office	2422775	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
Denmark	1551372

Supplementary Protection Certificates for TROXYCA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456	1790064-8	Sweden		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for TROXYCA ER

Introduction

TROXYCA ER, a combination of oxycodone hydrochloride and naltrexone hydrochloride, was approved by the U.S. Food and Drug Administration (FDA) in August 2016 for the management of severe pain requiring daily, around-the-clock, long-term opioid treatment. This article delves into the market dynamics and financial trajectory of TROXYCA ER, highlighting its unique features, regulatory environment, and the challenges it faced.

Abuse-Deterrent Properties

TROXYCA ER is distinguished by its abuse-deterrent properties, designed to reduce abuse when the capsules are crushed and administered via oral or intranasal routes. The formulation includes sequestered naltrexone, an opioid antagonist, which is released when the pellets are crushed, counteracting the effects of oxycodone[4].

Regulatory Approval and Exclusivity

The FDA approval of TROXYCA ER came with a significant regulatory backdrop. Pfizer was granted a period of exclusivity, including three years for the work done and an additional six months for pediatric studies. This exclusivity period effectively prevented other companies from entering the market with generic versions of the drug during this time[1].

Market Entry Challenges

Elite Pharmaceuticals, which was interested in developing a generic version of TROXYCA ER, faced significant hurdles due to Pfizer's exclusivity period. Elite's CEO, Nasrat Hakim, noted that Pfizer's decision to discontinue TROXYCA ER further complicated their efforts, as it prevented them from accessing the necessary technology to develop a generic version[1].

Pfizer's Decision to Discontinue

Pfizer decided not to introduce TROXYCA ER into the market, citing the availability of other abuse-deterrent oxycodone treatment options. This decision was critical in shaping the market dynamics, as it limited the availability of TROXYCA ER and impacted the potential for generic competition[1].

Risk Evaluation and Mitigation Strategy (REMS)

TROXYCA ER is subject to a REMS program to ensure its safe use. The REMS includes elements such as a Medication Guide, training for healthcare providers, and periodic assessments to evaluate the effectiveness of the strategy in mitigating risks associated with abuse, misuse, and overdose[2].

Clinical and Safety Considerations

The drug carries significant safety warnings, including risks of addiction, abuse, and misuse, as well as life-threatening respiratory depression. These risks are particularly heightened during the initiation of therapy or following dose increases. The drug's labeling also includes warnings about accidental ingestion, neonatal opioid withdrawal syndrome, and interactions with other CNS depressants[4][5].

Financial Implications

The financial trajectory of TROXYCA ER was heavily influenced by Pfizer's decision not to commercialize the drug. This decision meant that the drug did not generate significant revenue, despite its innovative abuse-deterrent properties. The exclusivity period and the lack of generic competition further limited the financial potential of TROXYCA ER.

Impact on Generic Manufacturers

For companies like Elite Pharmaceuticals, the inability to develop a generic version of TROXYCA ER due to Pfizer's exclusivity and discontinuation of the drug resulted in missed market opportunities. This scenario highlights the complex interplay between patent protection, regulatory exclusivity, and market competition in the pharmaceutical industry[1].

Market Performance of Similar Drugs

The market performance of other abuse-deterrent opioids provides context for understanding the potential financial trajectory of TROXYCA ER. While these drugs have seen varying degrees of success, the presence of multiple options in the market can lead to competitive pricing and reduced market share for any single product[1].

Expert Insights and Industry Trends

Industry experts emphasize the importance of abuse-deterrent formulations in addressing the opioid epidemic. However, the commercial success of such products depends on a range of factors, including regulatory support, market demand, and the presence of competing products. The case of TROXYCA ER underscores the challenges faced by innovative drugs in navigating these complexities[1][4].

Statistical Overview

• Approximately 115 Americans die daily from opioid overdoses, highlighting the urgent need for effective and safe opioid treatments[1].
• The average development and approval costs for antimicrobial drugs, while not directly comparable, illustrate the high costs associated with bringing new drugs to market, which can be even higher for complex formulations like TROXYCA ER[3].

Conclusion

The market dynamics and financial trajectory of TROXYCA ER are marked by regulatory exclusivity, Pfizer's decision to discontinue the drug, and the challenges faced by generic manufacturers. Despite its innovative abuse-deterrent properties, TROXYCA ER did not achieve significant market presence or financial success.

Key Takeaways

• TROXYCA ER was approved with unique abuse-deterrent properties but faced significant market entry challenges.
• Pfizer's exclusivity period and decision to discontinue the drug limited its market availability.
• The drug is subject to a REMS program to ensure safe use.
• The financial potential of TROXYCA ER was heavily impacted by these factors.
• The case highlights the complexities of bringing innovative drugs to market and the interplay between regulatory, competitive, and financial factors.

FAQs

1. What are the abuse-deterrent properties of TROXYCA ER?

TROXYCA ER contains sequestered naltrexone, which is released when the pellets are crushed, counteracting the effects of oxycodone and reducing abuse potential[4].

2. Why did Pfizer decide to discontinue TROXYCA ER?

Pfizer cited the availability of other abuse-deterrent oxycodone treatment options as the reason for not introducing TROXYCA ER into the market[1].

3. How did regulatory exclusivity affect the market for TROXYCA ER?

The exclusivity period granted to Pfizer prevented other companies from developing generic versions of TROXYCA ER, limiting market competition and generic entry[1].

4. What are the key safety considerations for TROXYCA ER?

TROXYCA ER carries warnings for addiction, abuse, and misuse, as well as life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome[4][5].

5. How does the REMS program impact the use of TROXYCA ER?

The REMS program includes a Medication Guide, training for healthcare providers, and periodic assessments to ensure the safe use of TROXYCA ER and mitigate associated risks[2].

Cited Sources:

1. Elite Pharma: Eyes on Troxyca, but Pfizer blocking generic release - Outsourcing-pharma.com
2. TROXYCA ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII - FDA
3. Antimicrobial Drugs Market Returns Analysis - ASPE
4. FDA Approves TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII - Pfizer
5. TROXYCA ER Labeling - Pfizer