Acetaminophen; hydrocodone bitartrate - Generic Drug Details

What are the generic drug sources for acetaminophen; hydrocodone bitartrate and what is the scope of freedom to operate?

Acetaminophen; hydrocodone bitartrate is the generic ingredient in twenty-one branded drugs marketed by Cent Pharms, Ivax Pharms, Forest Pharms, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Cypress Pharm Inc, Specgx Llc, Ucb Inc, Ascher, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Abana, Ortho Mcneil Pharm, Abbott, and Abbvie, and is included in one hundred and fifty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-eight suppliers are listed for this compound.

Summary for acetaminophen; hydrocodone bitartrate

US Patents:	0
Tradenames:	21
Applicants:	54
NDAs:	150
Finished Product Suppliers / Packagers:	38
Clinical Trials:	8
DailyMed Link:	acetaminophen; hydrocodone bitartrate at DailyMed

Recent Clinical Trials for acetaminophen; hydrocodone bitartrate

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

Sponsor	Phase
Sun Pharma Advanced Research Company Limited	Phase 1
Grünenthal GmbH	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3

See all acetaminophen; hydrocodone bitartrate clinical trials

Pharmacology for acetaminophen; hydrocodone bitartrate

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; hydrocodone bitartrate

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for acetaminophen; hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vintage Pharms Llc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040281-002	Sep 30, 1998		DISCN	No	No
Lannett Co Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	207172-001	Jun 22, 2017		DISCN	No	No
Specgx Llc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040400-001	Jul 26, 2000	AA	RX	No	Yes

Acetaminophen; hydrocodone bitartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen; Hydrocodone Bitartrate

Introduction

Hydrocodone bitartrate, often combined with acetaminophen, is one of the most widely prescribed opioid analgesics in the United States. This combination is used for managing moderate to severe pain and has a significant presence in the pharmaceutical market. Here, we will delve into the market dynamics and financial trajectory of this drug combination.

Market Overview

Prescription Volume and Trends

Hydrocodone-containing products are among the most frequently prescribed opioids in the U.S. In 2013, over 136.7 million prescriptions were dispensed, followed by 93.7 million in 2016 and 83.6 million in 2017[1].

• This high prescription volume indicates a substantial market demand, driven by the need for effective pain management.

Product Variations and Formulations

The market offers various formulations of hydrocodone bitartrate, including combination products with acetaminophen, available in tablets, capsules, and liquid forms[1][2][5].

• The diversity in formulations caters to different patient needs and preferences, contributing to the drug's widespread use.

Regulatory Environment

Controlled Substance Status

Hydrocodone bitartrate is classified as a Schedule II controlled substance under the Controlled Substances Act, indicating its high potential for abuse and dependence[1][4].

• This classification affects the drug's distribution, prescribing practices, and overall market dynamics, as stricter regulations and monitoring are in place.

FDA Approvals and Guidelines

The FDA has approved several hydrocodone bitartrate products, including extended-release formulations like Zohydro™ ER and Hysingla™ ER, which offer alternatives for patients requiring continuous pain management[3][4].

• FDA approvals and guidelines influence the market by ensuring that products meet safety and efficacy standards, which can impact prescribing habits and patient safety.

Financial Trajectory

Revenue and Sales

The financial performance of hydrocodone bitartrate products is significant due to their high prescription rates and widespread use.

• In 2013, the peak year, over 136 million prescriptions were filled, generating substantial revenue for pharmaceutical companies[1].
• Despite a decline in prescriptions in subsequent years due to revised clinical guidelines and efforts to reduce opioid prescribing, the market remains lucrative.

Impact of Opioid Crisis

The opioid crisis has led to increased scrutiny and regulatory measures aimed at reducing opioid prescriptions.

• This has resulted in a decline in the number of hydrocodone prescriptions, affecting the financial trajectory of these products. However, the need for pain management ensures a continued market presence[1].

Market Drivers

Pain Management Needs

The primary driver for the market is the ongoing need for effective pain management in various patient populations, including postoperative patients, trauma patients, and individuals with cancer[2][5].

• The efficacy of hydrocodone bitartrate in managing moderate to severe pain supports its market demand.

Abuse-Deterrent Formulations

The introduction of abuse-deterrent formulations, such as Zohydro™ ER and Hysingla™ ER, has provided an important therapeutic option for patients at risk of hepatic injury from acetaminophen or those needing extended-release opioids[3][4].

• These formulations have helped maintain market relevance by addressing safety concerns and providing alternative treatment options.

Market Challenges

Safety Concerns and Adverse Effects

The combination of hydrocodone bitartrate with acetaminophen carries risks such as liver toxicity due to high acetaminophen doses and the potential for opioid-related adverse effects like respiratory depression and addiction[2][5].

• These safety concerns necessitate careful prescribing practices and monitoring, which can impact market growth.

Regulatory and Legal Pressures

Stringent regulations and legal pressures due to the opioid crisis have led to a decrease in prescriptions and increased scrutiny on pharmaceutical companies and prescribers[1][3].

• This regulatory environment can limit market expansion and affect the financial performance of hydrocodone bitartrate products.

Competitive Landscape

Generic and Brand Name Products

The market is populated by numerous brand name and generic hydrocodone products, including combination products with acetaminophen[1][2].

• The presence of generics and multiple brand names increases competition, which can influence pricing and market share.

Alternative Pain Management Options

The availability of other opioid and non-opioid pain management options, such as morphine, fentanyl, and non-opioid analgesics, provides alternatives for prescribers and patients[4][5].

• This competition can impact the market share of hydrocodone bitartrate products.

Future Outlook

Continued Need for Pain Management

Despite the challenges, the ongoing need for effective pain management ensures that hydrocodone bitartrate products will remain relevant in the market[2][5].

Innovations in Formulations

The development of new formulations, such as extended-release and abuse-deterrent products, will continue to play a crucial role in the market dynamics[3][4].

Regulatory Adaptations

Pharmaceutical companies and healthcare providers will need to adapt to evolving regulatory environments and guidelines aimed at balancing pain management with safety and abuse prevention[1][3].

Key Takeaways

• High Prescription Volume: Hydrocodone bitartrate products are among the most frequently prescribed opioids.
• Regulatory Scrutiny: The drug is a Schedule II controlled substance, and its market is influenced by strict regulations.
• Safety Concerns: The combination with acetaminophen and opioid-related risks require careful prescribing and monitoring.
• Market Competition: The presence of generics and alternative pain management options affects market share and pricing.
• Future Relevance: The ongoing need for pain management and innovations in formulations ensure continued market presence.

FAQs

Q: What is the primary use of hydrocodone bitartrate?

A: Hydrocodone bitartrate is primarily used for managing moderate to severe pain in various patient populations, including postoperative patients, trauma patients, and individuals with cancer.

Q: Why is hydrocodone bitartrate classified as a Schedule II controlled substance?

A: Hydrocodone bitartrate is classified as a Schedule II controlled substance due to its high potential for abuse and dependence.

Q: What are the common formulations of hydrocodone bitartrate?

A: Hydrocodone bitartrate is available in combination with acetaminophen in tablets, capsules, and liquid forms, as well as in extended-release formulations like Zohydro™ ER and Hysingla™ ER.

Q: How has the opioid crisis affected the market for hydrocodone bitartrate products?

A: The opioid crisis has led to a decline in prescriptions and increased regulatory scrutiny, affecting the financial trajectory of these products.

Q: What are the safety concerns associated with hydrocodone bitartrate and acetaminophen?

A: The combination carries risks such as liver toxicity due to high acetaminophen doses and opioid-related adverse effects like respiratory depression and addiction.

Sources

1. Hydrocodone (Trade Names: Vicodin®, Lortab®, Lorcet-HD ...) - U.S. Department of Justice, Drug Enforcement Administration.
2. Hydrocodone and Acetaminophen - StatPearls, NCBI Bookshelf.
3. Case 1:14-cv-11689-RWZ Document 1 Filed 04/07/14 Page 1 of 21 - U.S. District Court for the District of Massachusetts.
4. Hydrocodone Bitartrate Extended-Release Tablets (Hysingla ER), C-II - U.S. Department of Veterans Affairs, Pharmacy Benefits Management.
5. Drug Use Criteria: Hydrocodone Bitartrate - Texas Health and Human Services, Vendor Drug Program.