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ANEXSIA 7.5/650 Drug Patent Profile
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When do Anexsia 7.5/650 patents expire, and when can generic versions of Anexsia 7.5/650 launch?
Anexsia 7.5/650 is a drug marketed by Mallinckrodt and is included in one NDA.
The generic ingredient in ANEXSIA 7.5/650 is acetaminophen; hydrocodone bitartrate. There is one drug master file entry 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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Questions you can ask:
- What is the 5 year forecast for ANEXSIA 7.5/650?
- What are the global sales for ANEXSIA 7.5/650?
- What is Average Wholesale Price for ANEXSIA 7.5/650?
Summary for ANEXSIA 7.5/650
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| DailyMed Link: | ANEXSIA 7.5/650 at DailyMed |
US Patents and Regulatory Information for ANEXSIA 7.5/650
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt | ANEXSIA 7.5/650 | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 089725-001 | Sep 30, 1987 | 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 |
ANEXSIA 7.5/650 (oxycodone 7.5 mg + acetaminophen 650 mg) market dynamics and financial trajectory
Executive summary: ANEXSIA 7.5/650 is a fixed-dose immediate-release opioid/acetaminophen combination product. Market dynamics are driven by (1) opioid prescribing and payer restrictions, (2) state and federal diversion-control policies, (3) generic substitution and product normalization after exclusivity windows, and (4) litigation and regulatory risk surrounding opioid supply chains. The financial trajectory is typically characterized by peak sales during early launch, followed by gradual share erosion from authorized generics and multisource generic competition, with incremental downside from adverse regulatory actions, REMS-aligned prescriber behavior, and payer utilization management.
No complete, product-specific public dataset is provided here (FDA Orange Book listing, NDA/ANDA holder, label changes, launch timing, or reported sales by quarter or NDC). Without those identifiers, a precise revenue curve, forecast, or litigation-adjusted TAM cannot be produced.
What drives market demand for ANEXSIA 7.5/650 (oxycodone/acetaminophen) vs other opioid combos?
ANEXSIA 7.5/650 competes within the oxycodone plus acetaminophen immediate-release combination segment. Demand is shaped by four interlocking levers:
1) Prescribing behavior under opioid risk controls
- U.S. opioid prescribing has trended down over the last decade, with prescriber adoption of risk-based controls (PDMP checks, dose minimization, and safer prescribing guidelines).
- Utilization shifts toward lower morphine milligram equivalent regimens and away from higher-risk schedules, increasing pressure on combination opioid products, especially where acetaminophen exposure is a known safety constraint.
2) Payer policies and step-edit requirements
- Commercial plans and PBMs commonly apply utilization management for short-acting opioid products, including:
- quantity limits (daily maximum tablets),
- prior authorization for early refills,
- claims edits tied to dose or overlapping opioid therapy.
- Medicare Part D and Medicaid programs increasingly align formularies to “preferred” opioid products, often favoring lower total cost multisource options.
3) Diversion mitigation and supply-chain friction
- Operational constraints from diversion enforcement and wholesaler monitoring can affect effective availability and channel fill.
- Products that are easier to procure through standard distribution may gain shelf share versus those subject to higher compliance friction.
4) Competitive substitution dynamics
- Fixed-dose oxycodone/acetaminophen products face frequent generic substitution once ANDA approvals occur and payer formularies update.
- Even where multiple brand products exist, share typically migrates toward the lowest net-cost options under rebates and plan contracting.
How many patents and exclusivity protections typically cover oxycodone/acetaminophen combinations like ANEXSIA 7.5/650?
ANEXSIA 7.5/650’s protection profile depends on its originating NDA, formulation, manufacturing, and method-of-use claims. In this class, exclusivity and patents tend to split into three buckets:
A) Composition and formulation patents
- Cover fixed-dose ratios, drug release characteristics, and excipient systems.
- Often broaden to polymorph/process claims that can delay generic manufacturing.
B) Manufacturing process patents
- Cover specific granulation, compression, coating, or stability methods.
- These claims can raise ANDA manufacturing/IP barriers even when the API actives are off-patent.
C) Method-of-use patents
- Can cover dosing regimens, titration schedules, or pain management protocols.
- These are less common than formulation claims for standard opioid/acetaminophen combinations, but they do appear in practice.
What matters financially: the sooner composition/process claims drop out (or are carved out via licensing/settlement), the faster net price declines and share erosion accelerates.
When does ANEXSIA 7.5/650 lose exclusivity or face generic entry risk?
Featured logic for this drug class:
- Exclusivity: brand revenues typically remain resilient through the periods of regulatory exclusivity tied to the brand’s NDA history (including patent term and statutory exclusivity, where applicable).
- Generic entry risk: accelerates after:
- Orange Book-listed patents expire or are invalidated,
- Paragraph IV challenges reach a settlement or final litigation outcome,
- Exclusivity blocks lift (if any).
Financial effect: generic entry typically produces a rapid share shift and steep net price compression in fixed-dose IR opioid combinations, especially when payers steer patients to the cheapest multisource.
What is the Orange Book status of ANEXSIA 7.5/650?
No Orange Book listing data is provided here (NDA number, application holder, listed patents, expiration dates, or exclusivity codes). A product-level Orange Book status cannot be stated reliably without those identifiers.
What generic entry risks exist for ANEXSIA 7.5/650 from ANDA applicants?
For oxycodone/acetaminophen IR combinations, generic entry risk typically manifests through:
- ANDA approvals for the same strength (7.5 mg/650 mg) and the same dosage form.
- “Skinny labels” and claims carving that target non-core patent scopes.
- Authorized generics that can blunt net-price decline compared with unauthored competitors.
Financial implication: the risk is not only clinical substitution but channel economics:
- pharmacy claims switching,
- PBM formulary updates,
- rebate re-contracting cycles.
What patent litigation affects ANEXSIA 7.5/650 and oxycodone/acetaminophen brands?
Opioid combination brands face patent and non-patent litigation risks. For the patent lane, typical events include:
- Paragraph IV notices to the NDA holder,
- district court claim construction and infringement rulings,
- Federal Circuit appeals that affect launch timing.
For the non-patent lane, the financial trajectory of opioid products is also affected by:
- state settlement frameworks and payer clawback dynamics,
- distributor/wholesaler conduct findings that can indirectly influence brand contracts.
No ANEXSIA-specific litigation docket facts are provided here, so a product-level litigation calendar cannot be constructed.
How strong is the patent estate for oxycodone/acetaminophen combinations like ANEXSIA 7.5/650?
In this therapeutic class, patent estate strength commonly turns on:
- whether key claims are composition/formulation or manufacturing method,
- whether the estate has active, unexpired patents at the time of generic challenges,
- whether claims are “easy to design around” (e.g., excipient substitutions that preserve equivalence).
Business lens: strong estates can sustain higher net pricing by delaying first generic launch, but once multiple generics launch, exclusivity value declines sharply.
How does ANEXSIA 7.5/650 compare with competing oxycodone/acetaminophen strengths and branded peers on pricing and share?
Across oxycodone/acetaminophen strengths (e.g., 5/325, 7.5/325, 10/325, and 7.5/650 variants), share tends to follow:
- formulary preference and coverage tiers,
- quantity and tablet-per-day limits,
- net cost competitiveness under PBM contracts,
- local pharmacy stocking patterns.
Typical competitive outcome in this segment: after generic consolidation, brands with higher unit cost lose volume unless they have:
- special contracting,
- payer-specific preferred status,
- co-pay programs that materially change patient out-of-pocket.
No pricing/share data for ANEXSIA is included in the prompt, so only the structural drivers can be stated.
What formulations are protected for ANEXSIA 7.5/650 (immediate-release tablet) and do they affect manufacturing cost?
Immediate-release opioid/acetaminophen tablets implicate:
- stability and dissolution profiles,
- excipient compatibility with both actives,
- manufacturing process controls for uniformity and content.
Where patents cover:
- dissolution or release characteristics,
- specific manufacturing steps that improve stability, generic manufacturing may require process adjustments that can elevate per-batch validation cost and delay commercialization.
Financially, that can postpone “effective” competition even after regulatory approval, because speed-to-market is part of earnings power.
Which companies distribute ANEXSIA 7.5/650 and how do channel economics influence financial trajectory?
Financial performance in this segment is sensitive to:
- wholesaler contract terms,
- rebate structures tied to volume,
- pharmacy group purchasing arrangements,
- chargebacks.
Without the product’s NDC-level or wholesaler contract data, the distribution and channel economics for ANEXSIA cannot be mapped.
How do FDA regulatory actions and controlled-substance enforcement affect sales of ANEXSIA 7.5/650?
Key regulatory dynamics affecting opioid combination brands:
- label changes (safety communications, acetaminophen dose warnings),
- Risk Evaluation and Mitigation Strategy (REMS) requirements,
- DEA controlled-substance compliance that can affect prescribing and dispensing throughput.
Net sales channel effect: when prescriber confidence declines or enforcement increases, volume can fall even without formal product withdrawal.
No FDA action timeline for ANEXSIA is included in the prompt, so a product-specific regulatory impact cannot be detailed.
What is the likely revenue curve for ANEXSIA 7.5/650 under typical opioid combo lifecycle economics?
A class-level lifecycle pattern usually looks like:
- Launch / early growth: ramp from prescriber education, brand awareness, and coverage inclusion.
- Mid-life normalization: steady demand tempered by prescribing downtrends and payer management.
- Loss of pricing power: occurs around:
- first generic introduction,
- subsequent multisource expansion.
- Late-life compression: net price declines faster than gross demand as patients and pharmacies move to lower-cost alternatives.
- Stochastic shocks: regulatory or enforcement events create volatility even after share loss.
Product-specific financials (actual revenue, unit sales, or gross-to-net) require identifiers not provided in the prompt.
Key Takeaways
- ANEXSIA 7.5/650’s market dynamics are governed by opioid prescribing downtrends, payer controls, generic substitution, and opioid risk enforcement.
- Financial trajectory for this fixed-dose IR opioid/acetaminophen segment typically shifts from brand pricing power to rapid net-price compression after generic entry.
- A definitive patent/exclusivity and Orange Book-based timeline cannot be stated for ANEXSIA 7.5/650 with the information provided.
- Litigation and regulatory risk can accelerate commercial deterioration beyond what generic competition alone would predict.
FAQs
- How do PDMP checks and opioid prescribing guidelines change demand for oxycodone/acetaminophen combination tablets?
- What typically happens to net price and pharmacy share after the first ANDA launch for oxycodone/acetaminophen strengths?
- Do method-of-use or manufacturing-process patents delay generic launches for opioid/acetaminophen fixed-dose combinations?
- How do acetaminophen safety communications affect formulary coverage for combination opioid products?
- What settlement outcomes most influence timing of generic entry for opioid combination brands?
References
No sources are cited because no ANEXSIA 7.5/650 identifiers (NDA/ANDA holder, Orange Book entries, patent numbers, exclusivity codes, or FDA dates) were provided in the prompt.
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