EXALGO Drug Patent Profile

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

Exalgo is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Exalgo

A generic version of EXALGO was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for EXALGO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	8
Patent Applications:	1,967
Drug Prices:	Drug price information for EXALGO
What excipients (inactive ingredients) are in EXALGO?	EXALGO excipients list
DailyMed Link:	EXALGO at DailyMed

See drug prices for EXALGO

See drug sales revenues for EXALGO

Recent Clinical Trials for EXALGO

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

Sponsor	Phase
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1
M.D. Anderson Cancer Center	Phase 3

See all EXALGO clinical trials

Paragraph IV (Patent) Challenges for EXALGO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	8 mg and 12 mg	021217	1	2010-09-02
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	16 mg	021217	1	2010-08-02

US Patents and Regulatory Information for EXALGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010		DISCN	Yes	No
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010		DISCN	Yes	No

Expired US Patents for EXALGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-004	Aug 24, 2012
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010

International Patents for EXALGO

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1025845	Thérapie utilisée en hydromorphone (Hydromorphone therapy)
Australia	693910
World Intellectual Property Organization (WIPO)	9601629
Spain	2186724

EXALGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EXALGO

Introduction to EXALGO

EXALGO, an extended-release formulation of hydromorphone hydrochloride, is a strong opioid pain medicine indicated for the management of moderate to severe pain in opioid-tolerant patients. It was marketed by Mallinckrodt Pharmaceuticals, a company that played a significant role in the opioid crisis in the United States[1][4].

Market Context

The global opioids drugs market, within which EXALGO operates, is driven by several key factors:

Growing Demand for Pain Therapeutics

The rising prevalence of chronic pain and the increasing need for effective pain management solutions are major drivers of the opioids market. EXALGO, as an extended-release opioid, was positioned to meet this demand, particularly for patients requiring continuous, around-the-clock opioid analgesia[3].

Regulatory Approvals and Innovations

Regulatory approvals and the development of innovative drug formulations, including abuse-deterrent formulations, have also contributed to the growth of the opioids market. However, EXALGO did not ultimately benefit significantly from these trends, as it was not a commercial success[1][3].

Marketing and Sales Strategies

Mallinckrodt employed several strategies to promote EXALGO, many of which have been criticized for their ethical implications:

Dedicated Sales Force

Mallinckrodt established a dedicated national sales force, the Specialty Pharmaceuticals Sales Team, to directly market EXALGO to physicians. This team was instrumental in promoting the drug, often through aggressive and misleading tactics[1].

Misrepresentation of Addiction Risks

The company's marketing strategy involved mischaracterizing the risk of addiction associated with EXALGO. This was done through various channels, including the company's website, sales force, and unbranded communications distributed through the C.A.R.E.S. Alliance, a coalition that Mallinckrodt created and led. This alliance was purportedly focused on reducing opioid abuse, but it was used to promote Mallinckrodt's opioids under the guise of responsible prescribing practices[1].

Targeting Doctors

Mallinckrodt, like other pharmaceutical companies, used data purchased from brokers to target doctors who were high prescribers of opioids. This data helped the company to rank doctors and tailor their marketing efforts to increase prescriptions of EXALGO[2].

Financial Performance and Settlements

Despite the aggressive marketing efforts, EXALGO did not achieve significant commercial success. Here are some key financial and legal milestones related to EXALGO and Mallinckrodt:

Commercial Failure

EXALGO was not a major commercial success for Mallinckrodt. The company stopped promoting the drug in 2015 and no longer sells it[2].

Legal Settlements

Mallinckrodt faced significant legal repercussions for its role in the opioid crisis. In 2020, the company agreed to pay $1.6 billion (later increased to $1.725 billion) to settle with states and the federal government. This settlement was part of a broader effort to resolve opioid litigation against the company[2].

Additional Legal Issues

In addition to the opioid-related settlements, Mallinckrodt also faced other legal issues, including allegations of underpaying rebates to the Medicaid program and paying illegal kickbacks related to another of its drugs, H.P. Acthar Gel. The company agreed to pay $260 million to resolve these allegations[2].

Impact on the Opioid Crisis

The marketing and sales strategies employed by Mallinckrodt for EXALGO contributed to the broader opioid crisis in the United States:

Awareness of Misconduct

Internal documents and DEA filings indicate that many within Mallinckrodt were aware that their actions were perpetuating the opioid crisis. Despite this awareness, the company continued to incentivize and supply suspicious sales of its opioids[1].

Public Health Consequences

The extensive misuse of opioids, including those marketed by Mallinckrodt, has led to a significant increase in opioid-related deaths and other public health issues. The company's actions have been widely criticized for their role in exacerbating this crisis[1][3].

Key Takeaways

• Aggressive Marketing: Mallinckrodt's marketing strategies for EXALGO involved misrepresenting the risk of addiction and targeting high-prescribing doctors.
• Commercial Failure: Despite these efforts, EXALGO was not a commercial success.
• Legal Repercussions: Mallinckrodt faced significant legal settlements and fines for its role in the opioid crisis and other misconduct.
• Public Health Impact: The company's actions contributed to the opioid crisis, highlighting the need for ethical and responsible marketing practices in the pharmaceutical industry.

FAQs

Q: What is EXALGO, and how is it used? A: EXALGO is an extended-release formulation of hydromorphone hydrochloride, used for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia[4].

Q: Why was EXALGO not a commercial success? A: Despite aggressive marketing, EXALGO did not achieve significant commercial success, leading Mallinckrodt to stop promoting it in 2015[2].

Q: What legal issues did Mallinckrodt face related to EXALGO and other opioids? A: Mallinckrodt faced significant legal settlements and fines for its role in the opioid crisis, including a $1.725 billion settlement, and additional allegations of underpaying rebates and paying illegal kickbacks[2].

Q: How did Mallinckrodt's marketing strategies contribute to the opioid crisis? A: Mallinckrodt's strategies involved misrepresenting the risk of addiction and targeting high-prescribing doctors, which contributed to the widespread misuse of opioids and the opioid crisis[1].

Q: What is the current status of EXALGO in the market? A: EXALGO is no longer promoted or sold by Mallinckrodt, and the company has faced significant legal and financial consequences for its past actions[2].

Sources

1. Inside “Operation Change Agent”: Mallinckrodt's Plan for Capturing ...
   • Duke University Press, 2024.
2. Documents Reveal Ties Between Opioid Makers and Doctors
   • ProPublica, 2022.
3. Opioids Drugs Market- Global Industry Analysis and Forecast (2023 ...
   • Maximize Market Research, 2023.
4. EXALGO- hydromorphone hydrochloride tablet, extended release
   • DailyMed, National Library of Medicine.