OPANA ER Drug Patent Profile

Which patents cover Opana Er, and what generic alternatives are available?

Opana Er is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are five patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and four patent family members in thirty-two countries.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Opana Er

A generic version of OPANA ER was approved as oxymorphone hydrochloride by IMPAX LABS on June 14^th, 2010.

Summary for OPANA ER

International Patents:	204
US Patents:	5
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	890
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OPANA ER
What excipients (inactive ingredients) are in OPANA ER?	OPANA ER excipients list
DailyMed Link:	OPANA ER at DailyMed

Paragraph IV (Patent) Challenges for OPANA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	20 mg, 30 mg and 40 mg	201655	1	2012-04-03
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	5 mg	201655	1	2012-03-26
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	7.5 mg, 10 mg, and 15 mg	201655	1	2012-03-23

US Patents and Regulatory Information for OPANA ER

OPANA ER is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011		DISCN	Yes	No				Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011		DISCN	Yes	No			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011		DISCN	Yes	No			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011		DISCN	Yes	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-003	Dec 9, 2011		DISCN	Yes	No			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011		DISCN	Yes	No				Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-003	Dec 9, 2011		DISCN	Yes	No				Y

Expired US Patents for OPANA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011

International Patents for OPANA ER

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20030048026
Mexico	PA06001452	FORMA DE ADMINISTRACION A PRUEBA DE ABUSO. (DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE.)
Ecuador	SP066345	FORMA DE ADMINISTRACIÓN A PRUEBA DE ABUSO
World Intellectual Property Organization (WIPO)	2007103105
South Africa	200904317	Improved method for making analgesics
Taiwan	I381860
Canada	2534925	FORME DE PREPARATION SECURISEE CONTRE UN EMPLOI ABUSIF (DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE)

OPANA ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Opana ER

Introduction

Opana ER, an extended-release formulation of oxymorphone, was a significant player in the opioid pain management market until its removal from the market in 2017. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual downfall.

Approval and Initial Success

Opana ER was first approved by the FDA in June 2006 for the management of moderate-to-severe pain requiring continuous, around-the-clock opioid analgesic therapy[4].

• The drug quickly gained traction, becoming Endo Pharmaceuticals' second best-selling drug. By 2009, Opana ER generated $172 million in net sales, accounting for approximately 12% of Endo’s total annual revenues[2].

Revenue Growth and Profitability

• From its modest start with $5 million in sales in 2006, Opana ER's sales grew significantly, reaching $384 million by 2011. In 2016, the last full year it was on the market, Opana ER generated almost $159 million in revenue[1][2].
• The drug was highly profitable for Endo, with prices far above the cost of manufacturing. Even after accounting for other direct expenses, Endo’s profit margin on Opana ER remained substantial[1][2].

Generic Competition and Patent Litigation

• The success of Opana ER attracted generic manufacturers. Impax Laboratories, among others, sought to market a generic version of the drug. Impax submitted an Abbreviated New Drug Application (ANDA) in 2007, asserting that Endo’s Opana ER patents were invalid or would not be infringed by Impax’s generic version[1][2].
• Endo sued Impax for alleged patent infringement, leading to a settlement in June 2010. Under this settlement, Endo agreed to pay Impax to abandon its patent challenge and delay entering the market with its generic version until January 2013. This deal included a "no-AG commitment" where Endo would not launch an authorized generic version during Impax’s initial 180 days on the market[2].

Reformulation and Abuse Concerns

• In 2012, Endo introduced a reformulated version of Opana ER designed to be resistant to physical and chemical manipulation for abuse by snorting or injecting. However, the FDA did not approve labeling describing potentially abuse-deterrent properties for this reformulation[4].
• Despite the reformulation, the abuse of Opana ER by injection continued, leading to serious health issues including outbreaks of HIV, hepatitis C, and cases of thrombotic microangiopathy. These concerns prompted the FDA to request the removal of Opana ER from the market in June 2017[3][4].

Financial Impact of FDA Request

• The FDA’s request to remove Opana ER from the market due to public health concerns marked a significant financial blow to Endo. The company had to find ways to preserve its revenues, including exploring the relaunch of a previous version of the product and entering into agreements with other companies like Impax[1].
• Endo settled a breach of contract suit with Impax in August 2017, agreeing that Impax would pay Endo a percentage of its oxymorphone ER profits in exchange for Endo refraining from competing with its own product. This agreement remains in effect today[1].

Impact on Generic Market

• The settlement between Endo and Impax effectively blocked other potential generic manufacturers from entering the market. Nine other companies had submitted ANDAs for generic oxymorphone ER, but none were able to market their products due to the terms of the Endo-Impax agreement[1].
• This arrangement ensured that Impax remained the sole generic seller of oxymorphone ER, benefiting from supracompetitive profits during its initial 180 days on the market and subsequent periods[2].

Financial Consequences for Endo

• The removal of Opana ER from the market and the agreements with Impax had significant financial implications for Endo. The company had to pay substantial amounts to Impax, including over $102 million as part of the "Endo Credit" to compensate for the lost sales due to the reformulation and delayed generic entry[2].
• Despite these challenges, the settlement allowed Endo to maintain some revenue stream through its agreement with Impax, albeit at a reduced level compared to the peak sales of Opana ER[1].

Public Health and Regulatory Perspective

• The FDA’s decision to request the removal of Opana ER was based on the drug’s public health consequences, particularly the risks associated with its abuse. This marked the first time the FDA had taken steps to remove a currently marketed opioid pain medication due to abuse concerns[4].
• The regulatory actions underscored the balance between providing pain management options and mitigating the risks of opioid abuse, a critical issue in the broader opioid crisis.

Key Takeaways

• Opana ER was a highly profitable drug for Endo Pharmaceuticals until its removal from the market in 2017.
• The drug's success was marred by abuse concerns, leading to a reformulation that ultimately did not mitigate the risks.
• Agreements with generic manufacturers, particularly Impax, allowed Endo to delay generic competition but at significant financial costs.
• Regulatory actions highlighted the need to balance pain management with public health safety.

FAQs

Q: When was Opana ER first approved by the FDA?

A: Opana ER was first approved by the FDA in June 2006[4].

Q: Why did the FDA request the removal of Opana ER from the market?

A: The FDA requested the removal due to the significant risks associated with the abuse of the drug, including injection-related health issues such as HIV, hepatitis C, and thrombotic microangiopathy[3][4].

Q: How did Endo Pharmaceuticals respond to the threat of generic competition for Opana ER?

A: Endo entered into a settlement with Impax Laboratories, agreeing to pay Impax to delay its generic entry and refrain from launching an authorized generic version during Impax’s initial 180 days on the market[2].

Q: What were the financial implications for Endo following the FDA’s request to remove Opana ER?

A: Endo had to pay substantial amounts to Impax as part of their agreement and lost significant revenue from the removal of Opana ER from the market[1][2].

Q: How did the reformulation of Opana ER impact its abuse?

A: Despite the reformulation intended to make the drug resistant to abuse, the abuse of Opana ER by injection continued, leading to serious health issues[4].

Sources

1. Federal Trade Commission. In the United States District Court [PDF].
2. Federal Trade Commission. Impax Laboratories Administrative Complaint [PDF].
3. NCBI. Trends in Opioid Use, Harms, and Treatment.
4. FDA. FDA requests removal of Opana ER for risks related to abuse.