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 Strides Pharma, 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.

Two suppliers are listed for this compound.

Summary for HYDROCODONE BITARTRATE; IBUPROFEN

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	2
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
Strides Pharma	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077723-002	Nov 6, 2006		DISCN	No	No
Strides Pharma	HYDROCODONE	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077723-003	Nov 6, 2006		DISCN	No	No
Teva	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076023-001	Apr 11, 2003		DISCN	No	No
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-001	May 28, 2013		DISCN	No	No
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-002	May 28, 2013		DISCN	No	No
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-001	Oct 12, 2004	AB	RX	No	Yes
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-004	May 28, 2013		DISCN	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	4,587,252
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	6,348,216
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	6,599,531

HYDROCODONE BITARTRATE; IBUPROFEN Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Hydrocodone Bitartrate and Ibuprofen?

Hydrocodone Bitartrate and Ibuprofen serve different segments within the analgesic market. Hydrocodone Bitartrate, an opioid analgesic, primarily addresses severe pain management, while Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), targets mild to moderate pain, inflammation, and fever.

Market Size and Value

• Hydrocodone Bitartrate: The North American opioid market has shown steady growth, valued at approximately $4.5 billion in 2022[1]. Hydrocodone accounts for about 35-40% of opioid prescriptions in the U.S., with annual sales around $1.8 billion[2].

• Ibuprofen: The global NSAID market was valued at $17 billion in 2022, with Ibuprofen representing nearly 20% of NSAID sales[3]. U.S. sales exceed $2 billion annually, with steady growth driven by OTC availability.

Key Market Drivers

• Hydrocodone Bitartrate:

  • Chronic pain prevalence and post-surgical pain management drive demand.

  • Regulatory shifts in prescribing practices impact supply and sales; reforms aim to curb misuse but limit access.

• Ibuprofen:

  • OTC accessibility supports consistent demand.

  • Rising prevalence of musculoskeletal conditions and demand for OTC pain relief boost sales.

Regulatory and Legal Factors

• Hydrocodone:

  • Reclassified from Schedule III to Schedule II in 2014 by the DEA, increasing prescribing restrictions.

  • Heightened oversight has decreased prescription volume by approximately 10-15% in recent years[4].

• Ibuprofen:

  • No significant regulatory changes; continued OTC sales.

  • Concerns over GI side effects led to development of combination products with protective agents.

Competitive Landscape

• Hydrocodone Bitartrate:

  • Several brand-name products (Vicodin, Norco) dominate; generic versions account for 80% of sales[5].

  • Manufacturers include Purdue Pharma (former), Sun Pharma, and Teva.

• Ibuprofen:

  • Major brands include Advil, Motrin, and generic store brands.

  • OTC segment faces competition from other NSAIDs like Naproxen.

What Is the Financial Trajectory for These Drugs?

Revenue Trends

• Hydrocodone Bitartrate:

  • Market revenue peaked around 2014, with a subsequent decline due to regulatory pressures.

  • Currently, annual sales hover around $1.5 billion, with projections indicating a 3% CAGR through 2027[6].

• Ibuprofen:

  • Stable revenue stream with modest growth rates (~2% CAGR) due to OTC demand and demographic factors.

  • Market size expected to reach approximately $20 billion globally by 2025[7].

R&D Investment and Patent Landscape

• Hydrocodone:

  • Limited innovation; most products off-patent. New formulations (e.g., abuse-deterrent) represent incremental R&D.

  • Patent expirations from 2016-2018 have increased generic competition.

• Ibuprofen:

  • No recent patent filings; focus on new formulations or combination products.

  • OTC nature limits patent protection; innovation mainly via delivery systems.

Pricing Trends

• Hydrocodone:

  • Prices have decreased due to generic competition.

  • Price per prescription averages around $50, with variations based on formulation and supplier.

• Ibuprofen:

  • Prices remain low due to OTC status; brand-name products cost approximately 20-30% more than generics.

Regulatory Impact on Financials

• Hydrocodone:

  • Regulatory constraints suppress growth; large suppliers focus on generic production and abuse-deterrent formulations.

• Ibuprofen:

  • Regulatory stability sustains sales; no major risk factors impacting financial trajectory.

What Are the Future Market and Financial Considerations?

• Hydrocodone Bitartrate:

  • The opioid crisis prompts ongoing regulatory tightening; potential for further restrictions or reclassification.

  • Demand may decline gradually as alternative pain management approaches evolve.

  • Rise of abuse-deterrent formulations may sustain some revenue, but overall market contraction is likely.

• Ibuprofen:

  • Continued OTC sales and aging population support incremental growth.

  • Innovation in delivery formats (e.g., patches, instant-release tablets) may enhance market share.

  • Competition from other NSAIDs and emerging analgesic classes could influence future sales.

Overall Outlook: Hydrocodone Bitartrate faces a shrinking, highly regulated market with moderate revenue, while Ibuprofen demonstrates steady growth driven by OTC sales and demographic factors.

Key Takeaways

• Hydrocodone Bitartrate's sales have plateaued or declined post-2014 due to regulatory restrictions and increased generic competition; its revenue is projected to decline slightly or stabilize through 2027.

• Ibuprofen maintains a stable, growing market characterized by OTC sales, with a CAGR of around 2%, projected to reach $20 billion globally by 2025.

• Regulatory environments significantly influence these drugs' market dynamics; opioids are under increasing scrutiny while NSAIDs face minimal legislative changes.

• Innovation in formulations—such as abuse-deterrent hydrocodone or novel delivery systems—could affect future revenue but remains limited.

• Overall, the opioid market's future looks constrained, while OTC analgesics like Ibuprofen will benefit from demographic trends and broad accessibility.

FAQs

1. How does regulatory change impact hydrocodone's sales? Regulatory actions, such as DEA reclassification, restrict prescribing, reduce access, and consequently diminish sales.

2. Why is Ibuprofen's market considered stable? Its OTC availability and demand for mild to moderate pain management maintain consistent sales with minimal regulation.

3. Are there new formulations of hydrocodone in development? Yes, including abuse-deterrent formulations, but their market impact remains limited and incremental.

4. How does generic competition affect pricing? Increased generics lower prices per unit and per prescription, reducing revenue margins for brand-name products.

5. What is the outlook for OTC NSAIDs like Ibuprofen? Growing aging populations and demand for accessible pain relief suggest continued growth, barring regulatory or safety concerns.

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Citations

[1] MarketResearch.com, "Opioids Market Size, Share & Trends," 2022.

[2] IQVIA, "Prescription Data Analytics," 2022.

[3] Grand View Research, "NSAID Market Analysis," 2022.

[4] DEA, "Reclassification of Hydrocodone," 2014.

[5] EvaluatePharma, "Generic vs. Brand Sales," 2022.

[6] Statista, "Hydrocodone Market Revenue," 2023.

[7] MarketsandMarkets, "NSAID Market Global Forecast," 2022.