ZOHYDRO ER Drug Patent Profile

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

Zohydro Er is a drug marketed by Recro Gainesville and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in twenty-three countries.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zohydro Er

A generic version of ZOHYDRO ER was approved as hydrocodone bitartrate by ALVOGEN on January 21^st, 2020.

Summary for ZOHYDRO ER

International Patents:	35
US Patents:	16
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	10
Drug Prices:	Drug price information for ZOHYDRO ER
Drug Sales Revenues:	Drug sales revenues for ZOHYDRO ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOHYDRO ER
What excipients (inactive ingredients) are in ZOHYDRO ER?	ZOHYDRO ER excipients list
DailyMed Link:	ZOHYDRO ER at DailyMed

See drug prices for ZOHYDRO ER

See drug sales revenues for ZOHYDRO ER

Paragraph IV (Patent) Challenges for ZOHYDRO ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOHYDRO ER	Extended-release Capsules	hydrocodone bitartrate	10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg	202880	1	2014-02-26

US Patents and Regulatory Information for ZOHYDRO ER

ZOHYDRO ER is protected by sixteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No			Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No			Y

Expired US Patents for ZOHYDRO ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013

International Patents for ZOHYDRO ER

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

Country	Patent Number	Title	Estimated Expiration
Norway	20090158
Colombia	5261536	COMPOSICION DE LIBERACION MODIFICADA MULTIPARTICULADA
Israel	188093

ZOHYDRO ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zohydro ER

Introduction

Zohydro ER, an extended-release formulation of hydrocodone, was approved by the FDA in 2013 for the management of severe pain that requires daily, around-the-clock, long-term treatment and for which alternative treatments are inadequate. This article delves into the market dynamics and financial trajectory of Zohydro ER, highlighting its unique position, controversies, and financial performance.

Approval and Controversy

Zohydro ER was approved despite significant controversy. An FDA advisory committee voted 11-2 against its approval in December 2012, citing concerns over its potential for addiction and abuse[4][5].

Market Position

Zohydro ER is the first single-entity, extended-release hydrocodone formulation available in the market. It is designed to provide pain relief lasting up to 12 hours and is available in strengths ranging from 10 mg to 50 mg of hydrocodone. This distinguishes it from immediate-release hydrocodone combination products, which typically contain a maximum of 10 mg of hydrocodone per unit dose[1][4].

Safety and Abuse Concerns

One of the primary concerns surrounding Zohydro ER is its high abuse potential and risk of addiction. It is classified as a Schedule II controlled substance due to these risks. The lack of abuse-deterrent properties in its initial formulation has been a significant point of criticism, with many organizations and state attorneys general requesting the FDA to reconsider its approval[4].

Regulatory Environment

The FDA has implemented new safety labeling changes for Zohydro ER and other extended-release/long-acting (ER/LA) opioids. These changes include revised indications, warnings about abuse and addiction, and requirements for prescribers to assess patient risk and monitor use. Additionally, post-market studies are mandated to assess the risks associated with long-term use of Zohydro ER[1].

Financial Performance

Zohydro ER is part of the portfolio of Currax Pharmaceuticals, which acquired the assets of Pernix Therapeutics, including Zohydro, in April 2019. Currax has shown strong operational and financial performance, exceeding growth expectations and generating over $70 million in revenue in just eight months. The company anticipates annual revenues in excess of $100 million and has reduced its debt by 30%[2].

Market Impact

Zohydro ER is expected to take market share from other opioids rather than increasing the overall number of patients treated with opioids. This is because many patients prescribed Zohydro ER are already on opioid therapy, either extended-release or immediate-release. The drug offers a new option for prescribers, particularly for patients who require high doses of hydrocodone without the risk of severe liver damage associated with acetaminophen-containing combination products[1].

Misconceptions About Potency

There have been misconceptions about the potency of Zohydro ER. While it has higher available strengths compared to immediate-release hydrocodone products, it is designed to deliver the same amount of medication per day with fewer doses. This makes it less potent than certain strengths of other ER/LA opioids like morphine sulfate, hydromorphone, oxymorphone, and oxycodone[1].

Strategic Focus

Currax Pharmaceuticals is focused on driving profitable growth for its branded portfolio, including Zohydro ER. The company is also actively evaluating strategic acquisition opportunities to advance its mission and expand access to clinically differentiated medicines[2].

Public and Professional Reaction

The approval of Zohydro ER has been met with criticism from law enforcement agencies, addiction experts, and various organizations. They argue that the introduction of a pure hydrocodone product could lead to an increase in overdoses. However, the FDA and Zogenix assert that the benefits of the medication outweigh its risks, especially for patients who have inadequate responses to alternative treatments[4][5].

Future Developments

The development of abuse-deterrent technologies for opioids is a priority for the FDA, but this area is still in its early stages. Research into adding abuse-deterrent properties to Zohydro ER is ongoing, though such formulations are still years away from FDA submission[1].

Key Takeaways

• Approval and Controversy: Zohydro ER was approved despite an FDA advisory committee's vote against it due to concerns over addiction and abuse.
• Market Position: It is the first single-entity, extended-release hydrocodone formulation, offering a new option for severe pain management.
• Safety Concerns: High abuse potential and lack of initial abuse-deterrent properties have been significant issues.
• Financial Performance: Part of Currax Pharmaceuticals' portfolio, it contributes to the company's strong financial performance.
• Market Impact: Expected to take market share from other opioids rather than increasing overall opioid use.
• Strategic Focus: Currax is focused on driving growth and evaluating strategic acquisitions.

FAQs

Q: What is Zohydro ER, and how does it differ from other hydrocodone products?

A: Zohydro ER is the first single-entity, extended-release hydrocodone formulation, providing pain relief for up to 12 hours. It differs from immediate-release hydrocodone combination products by offering higher available strengths without acetaminophen.

Q: Why was the approval of Zohydro ER controversial?

A: The approval was controversial due to concerns over its high abuse potential and risk of addiction, despite an FDA advisory committee voting against its approval.

Q: How does Zohydro ER fit into the market dynamics of opioids?

A: Zohydro ER is expected to take market share from other opioids rather than increasing the overall number of patients treated with opioids. It offers a new option for prescribers, particularly for patients requiring high doses of hydrocodone.

Q: What are the financial implications of Zohydro ER for its manufacturer?

A: Zohydro ER is part of Currax Pharmaceuticals' portfolio, which has shown strong operational and financial performance, generating significant revenue and reducing debt.

Q: Are there plans to add abuse-deterrent properties to Zohydro ER?

A: Yes, research into adding abuse-deterrent properties to Zohydro ER is ongoing, but such formulations are still years away from FDA submission.

Sources

1. FDA Provides Facts About Zohydro - FDA
2. Currax Pharmaceuticals Delivers Strong Operational and Financial Performance Eight Months into Operations - Currax Pharmaceuticals
3. Antimicrobial Drugs Market Returns Analysis - ASPE (not directly relevant but provides context on drug market dynamics)
4. Zohydro ER 2014 - College of Pharmacy, University of Texas
5. Zohydro to be Manufactured by Same Company That Makes Addiction Medicine - Drugfree.org