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-one 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:	2,915
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
Australia	2002337967	EXTENDED RELEASE COMPOSITION CONTAINING TRAMADOL
Canada	2495463	COMPOSITION A LIBERATION MODIFIEE CONTENANT DU TRAMADOL (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	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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

Last updated: June 8, 2026

CONZIP (Tramadol Hydrochloride Extended-Release): Market Dynamics and Financial Trajectory

CONZIP (tramadol hydrochloride extended-release, ER) has remained a branded opioid franchise in a tightening US regulatory and payer environment shaped by opioid risk controls, state and federal enforcement, and ongoing substitution pressure from AB-rated generics. Financial trajectory is dominated by (1) patent and exclusivity expiry milestones for brand protection, (2) generic penetration under FDA “same active ingredient/same dosage form” substitution rules, and (3) payer restrictions and opioid stewardship measures that cap volume growth and shift demand to lower-cost ER tramadol products.

How has CONZIP performed commercially since launch?

CONZIP is an ER tramadol product marketed in the US for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Commercial performance drivers

• Generic competition and price compression: Once AB-rated generic ER tramadol entries gain share, CONZIP’s market access narrows to fewer contracts and fewer cash-pay channels. The economic profile shifts from brand pricing to reimbursement-led volume protection.
• Opioid stewardship constraints: Formularies increasingly require prior authorization, step therapy, or restricted patient criteria for ER opioids, which reduces “unrestricted” script conversion for new starts.
• Safety messaging and prescriber behavior: Tramadol’s safety profile, including seizure risk and serotonin syndrome risk, drives prescriber selection away from ER products when alternative therapies are acceptable.
• Class-level demand effects: Any changes in the broader opioid category, including clinician education and enforcement actions, can reduce initiation rates even if continued prescriptions persist.

Net effect on revenue trajectory

• Early years typically show brand premium pricing and uptake.
• Mid-to-late lifecycle years show declining net sales due to generic erosion and contracting pressure, with only modest stabilization possible when generics face supply issues or when payer formularies keep an ER tramadol slot for longer-term maintenance patients.

What is CONZIP’s pricing and reimbursement environment?

CONZIP’s economics are strongly tied to how payers reimburse ER tramadol and how they treat branded opioids versus AB-rated generics.

Pricing and access dynamics

• WAC to net price gap: Brand opioid pricing is eroded by rebates, discounts, and restrictive contracting. Net price compresses as manufacturers lose preferred status.
• Formulary tiering: Many commercial formularies shift branded ER tramadol to non-preferred tiers or require prior authorization after generic availability.
• Medicaid and 340B: Medicaid and covered outpatient programs often drive faster generic adoption due to aggressive price-to-formulary policies.
• Institutional contracting: Hospitals and integrated delivery networks often apply tighter opioid pathways and may reduce ER opioid initiation.

Market-level outcome

• Even with stable demand in absolute units, revenue declines when generic uptake replaces higher-priced branded scripts.

When does CONZIP lose exclusivity, and what does that mean for share?

CONZIP’s revenue curve is structurally linked to the end of legal protection for the brand’s formulation, method-of-use, and any packaging/manufacturing IP, plus the practical effect of FDA approval timing for generics.

Exclusivity and generic timing mechanics

• Patent expiration: After relevant patents expire, multiple competitors can market AB-rated generics.
• 180-day exclusivity for first Paragraph IV filer(s): If a generic challenger wins eligibility for 180-day exclusivity, it can temporarily slow erosion by limiting number of competing entries.
• Post-exclusivity saturation: Once additional generic approvals launch and pharmacies switch based on price and contract, share typically shifts quickly away from the brand.

What to expect operationally

• Revenue usually declines in steps, not smoothly:
  1. pre-launch brand share retention,
  2. first generic entry with limited competition,
  3. full generic saturation after multiple launches.

What patents protect CONZIP, and how strong is the estate?

CONZIP’s patent estate matters because it governs whether ANDA filers face long stay risks or can launch. The strength of the estate also determines whether the brand can extend commercial life through enforcement-driven settlement stays.

Estate components that usually matter for ER tramadol brands

• Active ingredient and composition-of-matter coverage
• Formulation and controlled-release matrix patents
• Method-of-use patents (including dosing regimens and patient subsets)
• Manufacturing and process patents (improved release characteristics, impurity controls)
• Packaging and stability claims that support long shelf-life and patient compliance

How strength translates to financial trajectory

• Strong, enforceable, and expiry-late patents delay generic entry and support higher net pricing longer.
• Weak or narrowly scoped patents shorten the time window and increase probability of earlier generic launch, accelerating revenue compression.

What patent litigation and Paragraph IV challenges affect CONZIP?

For ER opioids, the market is often shaped by ANDA litigation where challengers file Paragraph IV certifications and seek to enter at risk. Settlement agreements can also shift entry timing.

Litigation mechanisms relevant to brand financial outcomes

• Automatic stay under 21 USC 355(j): Triggered by a timely suit after Paragraph IV notice, extending the period before FDA approval can convert into commercial entry.
• Settlement “carve-out” dates: If the parties settle, entry can be delayed until a negotiated date even after a patent challenge.
• Court rulings by asserted patent: Partial wins can allow some filings to proceed while others remain blocked.

Financial mapping

• Each litigation milestone creates a step-change risk for revenue:
  • suit dismissal or narrowing of asserted patents,
  • settlement that aligns launch dates,
  • court decisions that eliminate stays for certain challengers.

What is the Orange Book status of CONZIP?

Orange Book listings drive the ANDA approval and certification landscape. The number, type, and expiration dates of listed patents determine how many filing strategies are feasible.

How to interpret Orange Book data for CONZIP

• Listed patents by category: composition-of-matter, formulation, method-of-use, and others.
• Expiration dates: determine first potential generic entry points.
• Orphan exclusivity is not typical here: tramadol ER is not orphan, so the commercial clock is primarily patent and exclusivity.

Market impact

• A dense Orange Book with late expirations tends to support longer periods of delayed generic entry.
• Sparse listings or early expirations lead to faster erosion.

How many generics compete with CONZIP, and what is their market impact?

Generic competition typically accelerates revenue decline when multiple ANDA products launch and pharmacies switch.

Competitive dynamics to track

• Number of ANDA approvals: more entrants increases price competition.
• Therapeutic interchange: if payers and prescribers accept AB switching, brand share drops quickly.
• Drug shortages and supply constraints: shortages can temporarily restore brand utilization.
• Package size and dose coverage: ER tramadol brands often face substitution by dose availability; gaps reduce switching.

Expected financial profile

• Faster multi-entrant launches produce a steeper revenue decline.
• Slower entrant cadence can create longer stabilization windows.

How does CONZIP compare with other tramadol ER products?

In the ER tramadol segment, payer and pharmacy switching often depends on price, dose availability, and plan preferences.

Key comparison factors

• Formulation attributes: release profile and tolerability perceptions.
• Contracting position: preferred formulary status determines volume share.
• Generic alternatives: some products become less relevant when multiple generic ER tramadol options dominate.

Revenue implication

• Even if CONZIP retains prescriptions from stable patients, category-level contracting pressures limit upsides.

What regulatory actions are shaping CONZIP demand and economics?

US opioid regulation and enforcement influence prescribing patterns and payer access policies, which directly affect branded opioid market performance.

Regulatory and enforcement channels

• FDA opioid safety communications and label updates affecting prescriber confidence.
• State-level prescribing and dispensing controls that can reduce ER opioid initiation.
• Payer opioid policies: prior authorization, quantity limits, and restricted indications.

Economic effect

• These controls reduce “new-to-brand” starts and limit broader market expansion, making revenue more dependent on maintenance patients and incremental dose conversions.

What revenue sensitivity does CONZIP face from payer and policy changes?

CONZIP’s revenue is sensitive to payer utilization management because it is a controlled-class drug with strong substitution alternatives.

High-sensitivity levers

• Formulary tier changes: preferred to non-preferred shifts can cut net volume.
• Prior authorization adoption: increases friction and drops script conversion.
• Quantity limits and early refill denials: cap volumes even when patients remain on therapy.
• Step therapy requirements: drives prescribers to cheaper alternatives first.

Financial outcome

• Even modest policy tightening can produce meaningful net sales declines in a generics-heavy environment.

How could biosimilar dynamics matter for CONZIP?

Biosimilar dynamics are not directly applicable to CONZIP because the drug is a small-molecule product (tramadol ER), not a biologic. The competitive set is mainly generic small molecules, not biosimilars.

Key Takeaways

• CONZIP’s market dynamics are dominated by generic substitution pressure, with revenue exposed to stepwise declines as competing ANDA products launch and gain preferred contracting.
• Financial trajectory is highly sensitive to opioid stewardship policies, including prior authorization, quantity limits, and state-level controls that reduce ER opioid initiation.
• The investment-grade view of CONZIP’s future depends on the timing and scope of Orange Book patent listings and any Paragraph IV litigation/settlement that affects generic entry dates.
• The competitive outcome is typically driven less by clinical differentiation and more by payer access position and pricing compression once generics become abundant.

FAQs

1) Is CONZIP currently facing generic erosion, and what drives it?

Generic erosion is driven by AB-rated substitution rules, payer preferred contracting shifts, and the number and timing of ANDA launches for ER tramadol.

2) What usually causes the biggest revenue drops for branded ER opioids like CONZIP?

The biggest drops typically follow generic entry events when multiple competitors launch and when payer formularies move the brand to non-preferred status.

3) How do prior authorization and opioid quantity limits affect CONZIP net sales?

They reduce conversion of new prescriptions, lower script fill rates, and constrain utilization, which cuts net sales even if patient persistence remains stable.

4) Do settlement agreements change when generics can sell CONZIP?

Yes. Settlements can delay launches via negotiated entry dates or remaining stay windows after Paragraph IV litigation.

5) How should investors interpret Orange Book “listed patents” for CONZIP?

They indicate the IP barriers to generic approval timelines and help map the risk that challengers can launch earlier than expected if courts narrow or invalidate key claims.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
2. U.S. Food and Drug Administration. Approved Drug Products: Tramadol Hydrochloride Extended-Release (CONZIP) and related products (FDA label and application information). (FDA databases).