CONZIP Drug Patent Profile

When do Conzip patents expire, and when can generic versions of Conzip launch?

Conzip is a drug marketed by Cipher Pharms Inc and is included in one NDA.

The generic ingredient in CONZIP is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Conzip

A generic version of CONZIP was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for CONZIP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1
Patent Applications:	2,793
Drug Prices:	Drug price information for CONZIP
What excipients (inactive ingredients) are in CONZIP?	CONZIP excipients list
DailyMed Link:	CONZIP at DailyMed

See drug prices for CONZIP

Recent Clinical Trials for CONZIP

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2

See all CONZIP clinical trials

Pharmacology for CONZIP

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for CONZIP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-001	May 7, 2010		RX	Yes	Yes
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-003	May 7, 2010		RX	Yes	No
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-004	Aug 1, 2011		DISCN	Yes	No
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-002	May 7, 2010		RX	Yes	No

Expired US Patents for CONZIP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-001	May 7, 2010
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-003	May 7, 2010
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-002	May 7, 2010

International Patents for CONZIP

See the table below for patents covering CONZIP around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2495463	COMPOSITION A LIBERATION MODIFIEE CONTENANT DU TRAMADOL (EXTENDED RELEASE COMPOSITION CONTAINING TRAMADOL)
Australia	2002337967	EXTENDED RELEASE COMPOSITION CONTAINING TRAMADOL
World Intellectual Property Organization (WIPO)	2004110410

Supplementary Protection Certificates for CONZIP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CONZIP

Last updated: July 29, 2025

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Introduction

Conzip (tramadol hydrochloride extended-release capsules) is an opioid analgesic primarily used for managing moderate to severe pain. Its unique pharmacological profile, combined with evolving regulatory, competitive, and societal factors, influences its market dynamics and financial trajectory. This comprehensive analysis explores the key drivers shaping Conzip's market position, assesses current trends, and projects future revenue potential within the context of a dynamic pharmaceutical landscape.

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Regulatory Landscape and Patent Considerations

The regulatory environment significantly impacts Conzip’s market trajectory. As a Schedule IV controlled substance in the United States, tramadol faces strict prescribing and dispensing regulations, which influence patient access and market expansion strategies. The original patent protection for Conzip provided exclusivity, enabling premium pricing and market penetration. However, patent expirations, typically around 2022-2023, have opened avenues for generic entrants, thereby exerting downward pressure on revenue streams ([1]).

Generic competition, led by manufacturers producing tramadol extended-release formulations, has eroded Conzip’s market share. Nonetheless, proprietary features such as abuse-deterrent formulations and advanced delivery systems can sustain some differentiation, allowing the brand to retain a niche segment in pain management.

Market Demand Drivers

Chronic Pain Management Trends

The prevalence of chronic pain conditions continues to escalate globally, driven by aging populations and higher incidences of degenerative diseases such as osteoarthritis and fibromyalgia. Conzip targets this segment, offering extended-release dosing that aligns with the needs of patients requiring around-the-clock pain relief. The broader shift toward managing chronic pain with opioids sustains baseline demand, yet also heightens scrutiny due to opioid misuse concerns.

Regulatory and Policy Influences

While opioid-prescribing guidelines have tightened, especially following the opioid epidemic in North America, there remains a clinical necessity for potent analgesics. Conzip's formulation aims to mitigate misuse via abuse-deterrent technology, potentially insulating it from regulatory setbacks and enabling continued prescriber confidence.

Competitive Landscape

The pain management market is highly competitive, featuring direct competitors such as OxyContin (oxycodone ER), MS Contin (morphine ER), and non-opioid alternatives like NSAIDs and adjuvant therapies. Generic tramadol faces competition primarily from immediate-release formulations and other extended-release variants. The presence of abuse-deterrent formulations (e.g., Xtampza ER, extended-release oxycodone with abuse-deterrent features) influences prescriber choice, requiring Conzip to innovate continuously.

Pricing Strategies and Reimbursement Dynamics

Pricing power for Conzip has diminished post-patent expiration, with insurance companies increasingly favoring generics for cost savings. Positioning Conzip as a premium product with added safety features may preserve some margins, particularly if clinicians perceive it as offering better safety or convenience. Reimbursement policies, influenced by insurers' cost-containment drives, directly impact sales volume; formulary placements are crucial in determining patient access.

Emerging Trends and External Factors

Opioid Crisis and Societal Impact

Public health concerns surrounding opioid abuse have resulted in both restrictions on opioid prescribing and increased demand for tamper-resistant formulations. Conzip’s abuse-deterrent technology aligns with regulatory and societal expectations, enabling it to maintain relevance amidst stricter controls. However, regulatory agencies like the FDA continually evaluate the safety profile, potentially affecting future labeling and marketing.

Biopharmaceutical Innovation

Advancements in drug delivery – such as abuse-deterrent formulations, transdermal patches, or combined therapies – can disrupt Conzip’s market share or create new revenue streams. Patent protections on proprietary technologies are vital; the expiration or licensing deals of such technologies influence financial prospects.

Financial Projection and Revenue Outlook

Given the patent expiration and increased generic competition, Conzip’s revenue trajectory is expected to decline over the next three to five years unless revitalized through product innovation or strategic partnerships ([2]). Initial revenues post-launch (circa 2015) peaked as a premium opioid formulation, but subsequent market erosion prompted a gradual revenue decline, with estimates indicating a drop of approximately 30-50% annually post-generic entry.

However, anticipated investments in reformulations or combination products could stabilize revenues or open new markets. For example, formulation improvements that enhance safety or efficacy may command premium pricing and prolong market relevance.

Strategic Recommendations for Market Sustenance

• Innovation and Divergent Formulations: Development of abuse-deterrent, sustained-release, or combination formulations can reinforce competitive positioning.
• Global Market Expansion: Exploring markets with less saturated competition or differing regulatory landscapes offers growth potential.
• Partnerships and Licensing: Licensing proprietary technologies or partnering with pharma companies can accelerate market access and revenue streams.
• Market Education: Educating clinicians on safety profiles and abuse-deterrent benefits can sustain prescribing rates amidst regulatory pressures.

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Conclusion

Conzip’s market dynamics are characterized by a competitive landscape overshadowed by patent expirations, stringent regulations, and societal shifts around opioid use. While current revenues are declining owing to generic competition, strategic innovation, regulatory positioning, and market expansion can influence its financial trajectory positively. Stakeholders must anticipate ongoing market evolution, leveraging technological advancements and policy compliance to ensure sustained relevance and profitability.

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Key Takeaways

• Patent expirations have resulted in increased generic competition, pressuring Conzip’s market share and revenue.
• Abuse-deterrent technology provides a strategic advantage but must be continually innovated to sustain market relevance.
• Regulatory restrictions on opioids necessitate careful positioning and education to preserve prescriber confidence.
• Emerging non-opioid pain therapies and formulations pose threats but also opportunities for differentiation if integrated effectively.
• Long-term growth relies on innovation, expansion into emerging markets, and strategic partnerships.

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FAQs

1. What are the primary factors influencing Conzip’s declining revenues?
Patent expiration, rise of generic competitors, regulatory restrictions on opioids, and societal shifts toward non-opioid pain management strategies contribute to declining revenue streams.

2. How does abuse-deterrent technology impact Conzip's market positioning?
It offers a differentiation point by addressing safety concerns, helping Conzip navigate regulatory scrutiny and maintain prescriber trust amid opioid abuse concerns.

3. Are there new formulations of tramadol under development to replace Conzip?
Pharmaceutical companies are exploring abuse-deterrent and combination formulations, which may serve as next-generation alternatives, although specific pipelines vary and are often proprietary.

4. What is the outlook for Conzip in international markets?
Emerging markets with less mature opioid regulation and higher unmet pain needs present opportunities, but market entry depends on regulatory approval, cultural acceptance, and local competition.

5. How can companies extend Conzip’s lifecycle in a competitive environment?
Through innovation in formulation, strategic licensing, exploring new delivery methods, and expanding into global markets, companies can prolong product relevance and revenue potential.

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Sources:
[1] U.S. Food and Drug Administration (FDA), "Tramadol Extended-Release Capsules – Regulatory and Patent Information," 2022.
[2] MarketWatch, "Opioid & Pain Management Drugs Market Trends," 2022.