Hydrocodone bitartrate - Generic Drug Details

What are the generic drug sources for hydrocodone bitartrate and what is the scope of patent protection?

Hydrocodone bitartrate is the generic ingredient in eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Strides Pharma, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has three hundred and eighty-six patent family members in fifty countries.

There are sixteen drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydrocodone bitartrate

International Patents:	386
US Patents:	39
Tradenames:	11
Applicants:	18
NDAs:	19
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	31
Drug Prices:	Drug price trends for hydrocodone bitartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydrocodone bitartrate
What excipients (inactive ingredients) are in hydrocodone bitartrate?	hydrocodone bitartrate excipients list
DailyMed Link:	hydrocodone bitartrate at DailyMed

See drug prices for hydrocodone bitartrate

Recent Clinical Trials for hydrocodone bitartrate

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

Sponsor	Phase
Quivive Pharma, Inc.	PHASE1
National Institute on Drug Abuse (NIDA)	PHASE1
National Institute on Drug Abuse (NIDA)	Phase 1

See all hydrocodone bitartrate clinical trials

Generic filers with tentative approvals for HYDROCODONE BITARTRATE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE, EXTENDED RELEASE;ORAL
		10MG	CAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrocodone bitartrate

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate

Analgesics, Opioid

Antitussive Agents

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate

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

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
ZOHYDRO ER	Extended-release Capsules	hydrocodone bitartrate	10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg	202880	1	2014-02-26

US Patents and Regulatory Information for hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	9,421,200
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,763,933		Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	10,722,511
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	11,304,908		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No	11,304,908		Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,084,816		Y

Expired US Patents for hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	9,198,863
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	8,309,060
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014	6,733,783
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	9,675,611
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013	6,228,398
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	9,572,804

International Patents for hydrocodone bitartrate

Country	Patent Number	Title	Estimated Expiration
South Korea	101572336
European Patent Office	2200593	FORMULATION MÉDICAMENTEUSE CONTRE L'ABUS (ABUSE RESISTANT DRUG FORMULATION)
Mexico	367010	FORMAS DE DOSIS DE LIBERACION CONTROLADA ENCERRADAS RESISTENTES A MANIPULACIONES INDEBIDAS. (ENCASED TAMPER RESISTANT CONTROLLED RELEASE DOSAGE FORMS.)
Canada	2699142	FORMULATION MEDICAMENTEUSE CONTRE L'ABUS (ABUSE RESISTANT DRUG FORMULATION)
Portugal	2384754
Serbia	52798

Market Dynamics and Financial Trajectory for Hydrocodone Bitartrate

Last updated: July 27, 2025

Introduction

Hydrocodone Bitartrate, a potent opioid analgesic combined with acetaminophen or other non-opioid agents, remains a critical component in managing moderate to severe pain. Historically, it played a significant role in the US pharmaceutical market before regulatory interventions sharply altered its landscape. Analyzing its market dynamics and financial trajectory involves understanding regulatory developments, demand-supply factors, demographic trends, and the evolving landscape of pain management.

Regulatory and Legal Landscape

The regulatory environment has profoundly influenced the market dynamics for Hydrocodone Bitartrate. The U.S. Drug Enforcement Administration (DEA) classified it as a Schedule II controlled substance in 2014, establishing strict prescribing guidelines [1]. This reclassification curtailed overprescription and increased scrutiny, affecting revenue streams for manufacturers.

Similarly, the FDA's initiatives to combat opioid abuse led to the removal or reformulation of many hydrocodone-based products. The introduction of abuse-deterrent formulations (ADFs) aimed to curtail misuse but also elevated production costs and impacted market share, as consumers shifted towards alternative pain management options [2].

Market Demand and Prescription Trends

Demand for Hydrocodone Bitartrate steadily declined following heightened regulatory oversight, with prescription rates decreasing approximately 37% between 2015 and 2020 in the U.S. [3]. This decline is driven by increased awareness of opioid addiction risks, availability of alternative therapies (such as non-steroidal anti-inflammatory drugs and nerve blocks), and the proliferation of prescription drug monitoring programs (PDMPs).

Despite declining prescriptions, hydrocodone remains essential in acute pain management and palliative care, ensuring sustained, albeit reduced, demand. Furthermore, the global opioid market continues to evolve, with emerging markets showing variable adoption rates based on regulatory maturity and healthcare infrastructure.

Market Segmentation and Competitive Landscape

The market for Hydrocodone Bitartrate is characterized by limited suppliers mostly dominated by key pharmaceutical giants such as Purdue Pharma, Teva Pharmaceuticals, and Johnson & Johnson. The entry barrier is high due to stringent regulatory approval processes, manufacturing complexities, and patent protections, although many formulations are off-patent, leading to generic proliferation.

In response to regulatory and public health concerns, the market has shifted towards reformulated products with abuse-deterrent features. These innovations, while increasing production costs, aim to maintain market share by aligning with regulatory standards and consumer expectations for safer medications.

Pricing and Revenue Trajectory

Pricing strategies for hydrocodone products have experienced downward pressure amid increased competition and regulatory constraints. The average wholesale price (AWP) for hydrocodone formulations decreased by approximately 12% from 2018 to 2022 [4].

Revenue projections reflect a decline correlated with the reduced prescription volume, yet certain segments, such as deferred-use formulations and combination drugs, continue to generate substantial income. The overall revenue trajectory for Hydrocodone Bitartrate is expected to decline at a compound annual growth rate (CAGR) of approximately 5% over the next five years, driven mainly by refurbished formulations targeting chronic pain and opioid addiction treatment markets [5].

Impact of the Opioid Crisis and Policy Shifts

The opioid epidemic, particularly in North America, has drastically reshaped the market landscape. Stakeholders face substantial legal liabilities, leading to increased scrutiny on manufacturing practices, sales transparency, and advertising.

In 2021, multiple states implemented stringent prescribing limits, which directly impacted Hydrocodone Bitartrate demand. Additionally, policies favoring non-addictive analgesics and alternative therapies are projected to dampen future growth prospects [6].

Conversely, the opioid crisis has spurred the development of abuse-deterrent formulations and overdose reversal agents such as naloxone, indirectly influencing hydrocone product strategies and investments.

Emerging Trends and Future Outlook

The trajectory for Hydrocodone Bitartrate is closely intertwined with broader pain management innovations and systemic shifts toward combating opioid dependency. The growing emphasis on multimodal analgesia, including non-opioid options, and personalized medicine approaches, may further suppress long-term demand for traditional opioids.

However, hydrocodone formulations tailored for specific indications—such as post-surgical pain or palliative care—are likely to maintain niche markets. Moreover, regulatory relaxations in emerging markets, coupled with potential reforms around opioid prescribing, could reignite market opportunities.

Investment into research for safer, abuse-deterrent variants and combination therapies remains a strategic avenue, potentially stabilizing or slightly increasing revenues in select segments.

Key Market Players and Strategic Movements

Major pharmaceutical entities have adopted strategies focused on reformulation, market diversification, and compliance. For example, Purdue Pharma's withdrawal of original formulations and shift to abuse-deterrent products highlight strategic pivots in response to regulatory and societal pressures. Some companies are investing in alternative delivery systems such as extended-release formulations to mitigate misuse, which could influence revenue streams positively.

Financial Outlook Summary

• Revenue: Expected decline at a CAGR of approximately 5%, driven by reduced prescription volumes and regulatory hurdles.
• Pricing: Slight downward trend owing to increased generic competition and market saturation.
• Innovation: Continued investment in abuse-deterrent formulations aims to preserve market relevance despite declining traditional demand.

Conclusion

Hydrocodone Bitartrate's market dynamics exhibit a clear transition from widespread, high-volume prescriptions to a constrained, regulated niche. While regulatory and societal pressures suppress overall demand, strategic innovation in formulation and targeted application sustain certain revenue avenues. The financial trajectory predicts a gradual decline, emphasizing the importance of diversification and innovation for stakeholders in this space.

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Key Takeaways

• Regulatory impacts have substantially curtailed hydrocodone prescriptions, reshaping its market landscape.
• Demand decline is driven by increased awareness of opioid risks, alternative therapies, and regulatory controls.
• Innovation in abuse-deterrent formulations remains essential for retaining market relevance and profitability.
• Emerging markets could present growth opportunities contingent on regulatory reforms.
• Future outlook emphasizes responsible prescribing, alternative analgesic development, and strategic adaptation for sustained profitability.

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FAQs

1. How have regulations affected the price of Hydrocodone Bitartrate?
Regulatory measures and the proliferation of generics have exerted downward pressure on prices. The average wholesale price has decreased by roughly 12% from 2018 to 2022, reflecting increased competition and tighter prescribing guidelines.

2. What role do abuse-deterrent formulations play in the current market?
They are key to aligning with regulatory standards and combating misuse. Companies investing in ADFs aim to maintain market share despite declining traditional prescriptions, though these formulations are often more costly to produce.

3. Is Hydrocodone Bitartrate still a viable investment?
While revenues are declining, niche applications and ongoing innovation position certain segments for continued relevance. Investors should consider market regulations, societal trends, and pipeline developments when evaluating potential returns.

4. Are there opportunities in emerging markets?
Potential exists, especially where regulatory environments are evolving, and healthcare infrastructure is expanding. However, market entry may be limited by local regulations and societal attitudes toward opioids.

5. What are the prospects for alternative pain management therapies?
Advances in multimodal analgesia, non-opioid medications, and personalized pain treatment are expected to reduce reliance on hydrocodone, influencing its future demand and market share.

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References

[1] DEA Scheduling Information, U.S. Drug Enforcement Administration.
[2] FDA Abuse-Deterrent Opioids Initiative, U.S. Food and Drug Administration.
[3] National Prescription Audit, IQVIA.
[4] Pharmaceutical Pricing and Market Trends Report, IQVIA, 2022.
[5] MarketPro Report on Opioid Medications, 2023.
[6] Policy Watch: Opioid Prescribing Regulations, Johns Hopkins Bloomberg School of Public Health.