HYDROCODONE BITARTRATE; IBUPROFEN - Generic Drug Details

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

Hydrocodone bitartrate; ibuprofen is the generic ingredient in four branded drugs marketed by Nostrum Labs Inc, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for HYDROCODONE BITARTRATE; IBUPROFEN

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
DailyMed Link:	HYDROCODONE BITARTRATE; IBUPROFEN at DailyMed

Recent Clinical Trials for HYDROCODONE BITARTRATE; IBUPROFEN

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

Sponsor	Phase
Cephalon	Phase 1

See all HYDROCODONE BITARTRATE; IBUPROFEN clinical trials

Pharmacology for HYDROCODONE BITARTRATE; IBUPROFEN

Drug Class	Nonsteroidal Anti-inflammatory Drug Opioid Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCODONE BITARTRATE; IBUPROFEN

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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

Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	10 mg/200 mg	020716	1	2006-03-20
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	2.5 mg/200 mg	020716	1	2006-02-24

US Patents and Regulatory Information for HYDROCODONE BITARTRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	REPREXAIN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-004	Oct 19, 2007		DISCN	No	No
Amneal Pharms Ny	REPREXAIN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-003	Oct 19, 2007		DISCN	No	No
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-001	Oct 12, 2004	AB	RX	No	Yes
Teva	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076023-001	Apr 11, 2003		DISCN	No	No
Ani Pharms	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077454-001	Jun 23, 2010		DISCN	No	No
Nostrum Labs Inc	HYDROCODONE	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077723-003	Nov 6, 2006	AB	RX	No	No
Nostrum Labs Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077723-001	Nov 6, 2006	AB	RX	No	No

Expired US Patents for HYDROCODONE BITARTRATE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997

HYDROCODONE BITARTRATE; IBUPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocodone Bitartrate and Ibuprofen

Introduction

Hydrocodone bitartrate and ibuprofen, a combination of an opioid analgesic and a nonsteroidal anti-inflammatory drug (NSAID), is widely used for the short-term management of acute pain. This article delves into the market dynamics and financial trajectory of this medication, highlighting its usage, risks, and the impact of regulatory changes.

Market Overview

Demand and Usage

Hydrocodone bitartrate and ibuprofen, marketed under brand names such as Vicoprofen and Reprexain, is one of the most frequently prescribed opioid combinations in the United States. The demand for this medication is driven by its efficacy in managing moderate to moderately severe pain, particularly in post-surgical patients and those with acute injuries[2][4].

Prescription Trends

Historically, hydrocodone-containing products have been among the most prescribed opioids. In 2013, over 136.7 million prescriptions for hydrocodone-containing products were dispensed, with numbers gradually decreasing to 83.6 million in 2017 due to increased regulatory scrutiny and efforts to curb the opioid crisis[3].

Regulatory Environment

Opioid Crisis and Regulatory Changes

The opioid crisis has significantly impacted the market dynamics of hydrocodone bitartrate and ibuprofen. Regulatory bodies have implemented stricter guidelines for prescribing opioids, leading to a decline in prescriptions. For instance, the DEA reclassified hydrocodone from Schedule III to Schedule II in 2014, tightening its distribution and prescribing rules[3].

Safety Warnings and Contraindications

The use of hydrocodone bitartrate and ibuprofen is associated with serious risks, including opioid addiction, abuse, and misuse, which can lead to overdose and death. Life-threatening respiratory depression and cardiovascular thrombotic events are also significant concerns. These risks have led to stringent warnings and contraindications, further influencing prescribing practices[2][4].

Financial Trajectory

Revenue Impact

The financial trajectory of hydrocodone bitartrate and ibuprofen has been affected by the declining number of prescriptions. As regulatory measures to combat the opioid crisis have intensified, the revenue generated from these medications has decreased. Pharmaceutical companies have seen a reduction in sales, prompting a shift towards developing alternative pain management options with lower addiction potential.

Cost and Pricing

The cost of hydrocodone bitartrate and ibuprofen tablets can vary depending on the brand, generic availability, and insurance coverage. Generally, the combination product is priced lower than some other opioid analgesics, making it a more accessible option for patients. However, the overall cost to the healthcare system, including the costs associated with managing side effects and addiction, is a significant factor in the financial analysis[5].

Competitive Landscape

Market Competition

The market for pain management medications is highly competitive, with various opioid and non-opioid alternatives available. Hydrocodone bitartrate and ibuprofen competes with other combination products like hydrocodone and acetaminophen (Vicodin, Lortab), as well as with other NSAIDs and opioid-free pain relievers. The competitive landscape is further complicated by the introduction of new, potentially safer pain management options[3].

Patient and Physician Perspectives

Patient Compliance and Safety

Patients prescribed hydrocodone bitartrate and ibuprofen must be aware of the potential side effects and risks. Compliance with dosage instructions and regular monitoring by healthcare providers are crucial to minimize the risk of addiction and other adverse effects. Patients are also advised to report any history of lung disease, breathing difficulties, or other conditions that could interact with the medication[5].

Physician Prescribing Practices

Physicians are under increased scrutiny to prescribe opioids judiciously. They must assess each patient’s risk for addiction and regularly monitor for signs of abuse or misuse. The need for careful patient selection and ongoing monitoring has altered prescribing practices, contributing to the decline in prescriptions for hydrocodone bitartrate and ibuprofen[2][4].

Economic Impact

Healthcare System Costs

The economic impact of hydrocodone bitartrate and ibuprofen extends beyond the direct costs of the medication. The healthcare system bears significant costs related to managing opioid-related complications, including emergency department visits, hospitalizations, and rehabilitation programs. These indirect costs are substantial and have been a driving force behind efforts to reduce opioid prescriptions[3].

Future Outlook

Regulatory and Market Trends

The future outlook for hydrocodone bitartrate and ibuprofen is influenced by ongoing regulatory changes and market trends. As the healthcare industry continues to focus on safer pain management options, the demand for opioid-containing medications is likely to decrease further. Pharmaceutical companies are investing in research and development of alternative pain therapies, which may eventually replace or reduce the reliance on hydrocodone bitartrate and ibuprofen[3].

Innovations in Pain Management

Innovations in pain management, such as the development of non-opioid analgesics and advanced delivery systems, are expected to shape the market. These innovations aim to provide effective pain relief with lower risks of addiction and side effects, potentially displacing hydrocodone bitartrate and ibuprofen in the treatment arsenal[5].

Key Takeaways

• Regulatory Impact: Stricter regulations and reclassification of hydrocodone have significantly reduced prescriptions.
• Financial Decline: Revenue from hydrocodone bitartrate and ibuprofen has decreased due to reduced prescriptions and increased regulatory scrutiny.
• Competitive Market: The market is highly competitive with various alternatives available, including non-opioid pain relievers.
• Patient and Physician Awareness: Increased awareness of risks and side effects has led to more cautious prescribing practices.
• Economic Burden: The healthcare system continues to bear substantial costs related to opioid-related complications.

FAQs

Q: What are the primary components of hydrocodone bitartrate and ibuprofen tablets?

A: Hydrocodone bitartrate and ibuprofen tablets combine an opioid analgesic (hydrocodone) with a nonsteroidal anti-inflammatory drug (ibuprofen)[1][4].

Q: What are the major risks associated with hydrocodone bitartrate and ibuprofen?

A: The major risks include opioid addiction, abuse, and misuse, life-threatening respiratory depression, and cardiovascular thrombotic events[2][4].

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

A: The opioid crisis has led to stricter regulatory measures, reduced prescriptions, and a decline in revenue for hydrocodone bitartrate and ibuprofen[3].

Q: What are the typical dosages for hydrocodone bitartrate and ibuprofen?

A: The typical dosage is 7.5 mg hydrocodone and 200 mg ibuprofen every 4 to 6 hours as needed, with no more than five pills in a 24-hour period[5].

Q: Are there any specific precautions for patients taking hydrocodone bitartrate and ibuprofen?

A: Patients should avoid taking other NSAIDs, report any sensitivity to aspirin or similar drugs, and be cautious if they have a history of lung disease or are taking other medications that could interact with hydrocodone bitartrate and ibuprofen[5].

Sources

1. DailyMed: Hydrocodone Bitartrate and Ibuprofen tablet, film coated.
2. Drugs.com: Hydrocodone and Ibuprofen: Package Insert / Prescribing Info.
3. DEA: Hydrocodone (Trade Names: Vicodin®, Lortab®, Lorcet-HD®, Hycodan®, Vicoprofen®).
4. DailyMed: Hydrocodone Bitartrate and Ibuprofen tablet.
5. Arthritis Foundation: Hydrocodone Bitartrate with Ibuprofen.