HYSINGLA ER Drug Patent Profile

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

Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and fourteen patent family members in forty-nine countries.

The generic ingredient in HYSINGLA 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 Hysingla Er

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

Summary for HYSINGLA ER

International Patents:	314
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	61
Drug Prices:	Drug price information for HYSINGLA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYSINGLA ER
What excipients (inactive ingredients) are in HYSINGLA ER?	HYSINGLA ER excipients list
DailyMed Link:	HYSINGLA ER at DailyMed

See drug prices for HYSINGLA ER

See drug sales revenues for HYSINGLA ER

Pharmacology for HYSINGLA ER

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Paragraph IV (Patent) Challenges for HYSINGLA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	30 mg, 40 mg, 80 mg, and 100 mg	206627	1	2015-05-08
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	20 mg, 60 mg, and 120 mg	206627	1	2015-04-15

US Patents and Regulatory Information for HYSINGLA ER

HYSINGLA ER is protected by twenty US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No	9,486,413		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No	8,808,740		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,095,614
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,861,584		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No	9,095,614
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No	9,486,412		Y

Expired US Patents for HYSINGLA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014	9,669,024
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	10,369,109
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	9,517,236
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	9,675,611
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	8,309,060
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	9,023,401

International Patents for HYSINGLA ER

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

Country	Patent Number	Title	Estimated Expiration
Germany	602007002596
Israel	173478	FORM OF ADMINISTRATION SECURED AGAINST MISUSE
Croatia	P20171695
Serbia	52463	FARMACEUTSKI DOZNI OBLICI REZISTENTNI NA ZLOUPOTREBU KOJI SADRŽE OPIOIDNI ANALGETIK (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC)
Spain	2357376
Spain	2411695

HYSINGLA ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hysingla ER

Introduction

Hysingla ER (hydrocodone bitartrate) is an extended-release opioid analgesic approved by the FDA in November 2014 for the management of severe pain requiring daily, around-the-clock, long-term opioid treatment. Here, we delve into the market dynamics and financial trajectory of Hysingla ER, examining its launch, market performance, and the factors influencing its sales.

Market Launch and Initial Reception

Hysingla ER was commercially launched in the U.S. by Purdue Pharma in 2015, marking a significant entry into the opioid market with its abuse-deterrent properties[5].

Indications and Limitations of Use

Hysingla ER is indicated for patients with severe pain that cannot be managed by alternative treatments. However, due to the risks of addiction, abuse, and misuse, it is reserved for patients where other options are ineffective or not tolerated[5].

Abuse-Deterrent Properties

One of the key selling points of Hysingla ER is its abuse-deterrent formulation. While it does not completely prevent abuse, it is designed to reduce the likelihood of abuse when the drug is chewed, crushed, or dissolved and then taken orally, snorted, or injected[1][4].

Market Performance

Sales Trends

The sales of Hysingla ER have shown a mixed trend since its launch. Initially, there was a significant decline in sales, particularly noted in the first half of 2018, with a 20% drop from Q1 to Q2. This decline was followed by a stable downward trend[3].

Comparative Market Analysis

Hysingla ER's sales decline mirrors the broader trend in the opioid market, which has been impacted by increased regulatory scrutiny, public health concerns, and changes in prescribing practices. For example, OxyContin, another major opioid product, also experienced significant declines in sales during similar periods[3].

Impact of Generic Alternatives

The introduction of generic alternatives has further affected the sales of Hysingla ER. For instance, the launch of a generic version of transdermal buprenorphine (Butrans) led to a sharp decline in its sales, highlighting the competitive pressure from generic products[3].

Regulatory Environment

FDA Approval and REMS

Hysingla ER was approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. This includes a Medication Guide, elements to assure safe use, and regular assessments of the REMS[2].

Public Health Concerns

The opioid crisis has led to increased regulatory scrutiny and public health initiatives aimed at reducing opioid misuse. These efforts have impacted the prescribing and sales of opioids, including Hysingla ER[2].

Clinical and Safety Considerations

Efficacy and Safety Studies

Clinical studies have shown that Hysingla ER is effective in managing severe pain, with higher responder rates compared to placebo. However, it also comes with significant safety concerns, including the risk of addiction, abuse, and life-threatening respiratory depression[4].

Adverse Events and Contraindications

Common adverse events include those typical of opioid analgesics, such as respiratory depression, hypotension, and gastrointestinal obstruction. The drug is contraindicated in patients with impaired consciousness, coma, or circulatory shock[5].

Financial Implications

Revenue Impact

The decline in sales of Hysingla ER has significant financial implications for Purdue Pharma. The reduction in revenue from this product, combined with the broader decline in opioid sales, has contributed to the financial challenges faced by the company[3].

Legal and Settlement Costs

Purdue Pharma has also faced substantial legal and settlement costs related to the opioid crisis, further impacting its financial health. These costs have been a major factor in the company's financial trajectory[3].

Competitive Landscape

Hysingla ER operates in a competitive opioid market with other extended-release products like OxyContin and Zohydro ER. The market is characterized by intense competition, regulatory pressures, and shifting consumer and prescriber preferences[4].

Future Outlook

The future outlook for Hysingla ER is complex and influenced by several factors:

Regulatory Changes

Continued regulatory scrutiny and potential changes in opioid prescribing guidelines could further impact sales.

Market Trends

The trend towards non-opioid analgesics and alternative pain management options may continue to affect the demand for Hysingla ER.

Public Health Initiatives

Public health initiatives aimed at reducing opioid misuse will likely continue to shape the market dynamics for Hysingla ER and other opioid products.

Key Takeaways

• Abuse-Deterrent Properties: Hysingla ER has properties designed to reduce but not eliminate abuse.
• Sales Trends: Sales have declined significantly since 2018, mirroring broader opioid market trends.
• Regulatory Environment: The drug is subject to a REMS and faces increased regulatory scrutiny.
• Clinical and Safety Considerations: It is effective for severe pain but comes with significant safety risks.
• Financial Implications: The decline in sales and legal costs have impacted Purdue Pharma's financial health.
• Competitive Landscape: The market is highly competitive with other extended-release opioids.

FAQs

1. What is Hysingla ER used for? Hysingla ER is used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

2. What are the abuse-deterrent properties of Hysingla ER? Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.

3. Why have sales of Hysingla ER declined? Sales have declined due to a combination of factors including increased regulatory scrutiny, public health concerns, changes in prescribing practices, and the introduction of generic alternatives.

4. What are the significant safety concerns associated with Hysingla ER? Significant safety concerns include the risk of addiction, abuse, life-threatening respiratory depression, hypotension, and gastrointestinal obstruction.

5. How does Hysingla ER fit into the broader opioid market? Hysingla ER is part of a highly competitive opioid market with other extended-release products, facing intense competition and regulatory pressures.

Sources

1. FDA News Release: FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties.
2. FDA Letter: Hysingla ER (hydrocodone bitartrate) extended-release tablets.
3. Maine.gov: 19-23649-rdd Doc 4856 Filed 05/20/22.
4. PBM.VA.Gov: Hydrocodone Bitartrate Extended-Release Tablets (Hysingla ER), C-II.
5. PR Newswire: Hysingla™ ER (hydrocodone bitartrate) Extended-Release Tablets CII Now Available.