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Last Updated: March 26, 2026

NORCO Drug Patent Profile


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When do Norco patents expire, and what generic alternatives are available?

Norco is a drug marketed by Apil and is included in two NDAs.

The generic ingredient in NORCO is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

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Drug patent expirations by year for NORCO
Drug Prices for NORCO

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Drug Sales Revenue Trends for NORCO

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US Patents and Regulatory Information for NORCO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-004 Jul 7, 2014 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-003 Sep 12, 2000 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040099-001 Jun 25, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for NORCO (Hydrocodone/Acetaminophen)

Last updated: February 23, 2026

What is the market position of NORCO?

NORCO is a brand name for a combination analgesic containing hydrocodone and acetaminophen, commonly used for moderate to severe pain management. Once a leading opioid prescribed for pain, NORCO's market share has declined due to regulatory actions and the opioid crisis.

Market Overview

  • Historical Market Share: NORCO was among the top prescribed opioids in the U.S. with over 20 million prescriptions annually before 2010.
  • Decline: Post-2010, the market share of NORCO decreased sharply due to increased regulation and litigation against opioid manufacturers and distributors.
  • Current Status: It is classified as a Schedule II controlled substance in the U.S., with prescriptions declining by approximately 40% from 2010 to 2022.

Key Market Drivers

  • Regulation and Legislation: Stricter prescribing guidelines, including CDC guidelines in 2016, restrict opioid use.
  • Legal Risks: Manufacturers face ongoing litigation, leading to product withdrawals.
  • Alternative Therapies: Increased adoption of non-opioid pain treatments reduces demand.
  • Pandemic Impact: COVID-19 slowed healthcare visits, temporarily decreasing prescriptions further.

How have regulatory policies affected NORCO's market?

  • FDA Warnings: The FDA issued boxed warnings and requested label changes to limit misuse and overdose risks.
  • DEA Scheduling: Hydrocodone combined products reclassified from Schedule III to Schedule II in 2014, increasing prescribing restrictions.
  • Legal Actions: Purdue Pharma, the primary manufacturer of NORCO, faced over 2,000 opioid-related lawsuits, prompting settlements and product discontinuations.

What is the financial trajectory for NORCO?

Revenue Trends

Year U.S. Prescriptions Estimated Market Revenue (USD millions) Change from Prior Year
2010 20 million 2,500
2015 12 million 1,500 -40%
2020 8 million 1,000 -33%
2022 6 million 750 -25%

Note: Revenue includes both brand and generic formulations, with generics accounting for approximately 70%.

Key Factors Impacting Financials

  • Patent and Formulation Changes: Patent expirations and the shift to generics led to price erosion.
  • Manufacturing and Litigation Costs: Legal settlements and manufacturing adjustments impact profit margins.
  • Market Shift: Growing preference for non-opioid alternatives, such as NSAIDs and nerve pain treatments, reduces overall revenue potential.
  • Withdrawal from Markets: Some manufacturers have withdrawn NORCO products in response to legal and regulatory pressures.

How does the competitive landscape look?

  • Generic Market Dominance: Generics account for the majority of prescriptions, reducing brand value.
  • Emerging Alternatives: Non-opioid analgesics like tramadol, gabapentin, and topical treatments expand options.
  • Legal and Social Risks: Potential liabilities and changing societal attitudes toward opioids limit future growth.

What are the strategic outlooks?

  • Market Contraction: Expect further decline in prescriptions and revenue within the next 2-5 years.
  • Product Discontinuation: Several manufacturers have removed NORCO components from the market.
  • Regulatory Environment: Future policies likely to tighten restrictions, affecting supply and profitability.
  • Pipeline Developments: Consideration of alternative formulations, such as abuse-deterrent technologies, though adoption remains limited.

Key Takeaways

  • NORCO experienced significant market share decline due to regulation, litigation, and evolving prescribing practices.
  • Revenue has contracted by approximately 70% since 2010, with ongoing downward trends expected.
  • The landscape has shifted toward generics and non-opioid therapies, reducing profitability.
  • Legal risks and societal pressures hinder market recovery prospects.
  • Industry participants are focusing on abuse-deterrent formulations and non-opioid alternatives to sustain revenue streams.

FAQs

Q1: Will NORCO return to higher prescription levels?
A1: Unlikely. Regulatory, legal, and societal barriers suppress future growth.

Q2: Are generic versions still available?
A2: Yes, generics dominate the market; prescriptions for hydrocodone/acetaminophen formulations still exist but in declining numbers.

Q3: What legal risks impact NORCO's market?
A3: Manufacturers face lawsuits related to opioid misuse and overdose, prompting product withdrawals and settlements.

Q4: How have recent policies affected opioid-based therapies?
A4: Policies restrict prescribing, introduce abuse-deterrent technologies, and promote alternative pain management strategies.

Q5: What is the outlook for stakeholders involved with NORCO?
A5: Investors and manufacturers should expect declining revenues, increased regulatory costs, and a shift toward non-opioid pain therapies.


References

[1] CDC. (2016). Guideline for prescribing opioids for chronic pain. Centers for Disease Control and Prevention.

[2] FDA. (2021). Safety communication on opioids. Food and Drug Administration.

[3] IMS Health. (2022). U.S. prescription data report.

[4] Purdue Pharma. (2022). Litigation and settlement updates.

[5] U.S. Drug Enforcement Administration. (2014). Rescheduling of hydrocodone products.

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