Share This Page
DARVOCET-N 100 Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Darvocet-n 100, and what generic alternatives are available?
Darvocet-n 100 is a drug marketed by Xanodyne Pharm and is included in one NDA.
The generic ingredient in DARVOCET-N 100 is acetaminophen; propoxyphene napsylate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.
US Patents and Regulatory Information for DARVOCET-N 100
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xanodyne Pharm | DARVOCET-N 100 | acetaminophen; propoxyphene napsylate | TABLET;ORAL | 017122-002 | Approved Prior to Jan 1, 1982 | 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 |
DARVOCET-N 100 Market Analysis and Financial Projection
DARVOCET-N 100: Investment Scenario and Fundamentals Analysis
What is DARVOCET-N 100 and why does it matter commercially?
DARVOCET-N 100 is a fixed-dose opioid analgesic product historically marketed in the U.S. It contains propoxyphene napsylate (propoxyphene) and acetaminophen. The brand formulation and labeling evolved over time, but the key business point is structural: propoxyphene is no longer a viable commercial platform in the U.S. after regulatory action, which makes DARVOCET-N 100’s future returns primarily a question of legacy demand, geographic persistence, and litigation/settlement dynamics rather than ongoing product-led growth.
How did regulators reshape the long-term demand outlook?
In the U.S., propoxyphene faced long-running safety concerns centered on cardiac toxicity and QT prolongation risk. In 2009, the FDA requested withdrawal of propoxyphene from the market in the United States, and the manufacturer action effectively removed the active ingredient from mainstream availability. DARVOCET-N 100 is a propoxyphene brand, so the product’s investable pathway in the U.S. collapsed once propoxyphene left the market. The FDA public actions included risk-based regulatory steps that culminated in withdrawal of propoxyphene products from U.S. distribution. [1]
Investment implication: U.S.-centric unit growth is structurally capped at “legacy only.” Future value is dominated by (1) settlement economics and (2) residual international exposure, if any exists in markets that still permit propoxyphene.
DARVOCET-N 100 fundamentals: market, pricing, and survivability
What does the product’s revenue model look like post-withdrawal?
With propoxyphene withdrawn in the U.S., DARVOCET-N 100’s revenue model shifts away from classic commercialization toward one or more of these buckets:
- Residual channel inventory liquidation (time-limited and dependent on remaining supply)
- Secondary market activity (non-authorized, limited by enforcement and supply chain controls)
- International markets (if propoxyphene remains authorized and manufactured locally)
In practical investment terms, the fundamentals become less about brand strength and more about regulatory status, enforceability, and legal exposure.
What is the regulatory “survivability” profile?
- U.S. status: Propoxyphene withdrawal requested and implemented; DARVOCET-N 100 has no standard U.S. growth curve post-action. [1]
- FDA safety basis: Cardiac safety concerns drive risk management and removal decisions. [1]
This produces an asymmetric downside profile: even if demand exists, regulatory access constraints typically limit legal supply.
Competitive and therapeutic landscape: what replaces it?
Which drug classes filled the therapeutic gap?
DARVOCET-N 100 sat in the opioid analgesic segment. Following its exit, the market’s analgesic replacement pattern generally aligns with:
- Other opioids (brand and generic)
- Non-opioid analgesics (NSAIDs, acetaminophen-based regimens)
- Mixed-risk regimens driven by changing pain-management policies
Investment implication: DARVOCET-N 100 is not competing for share in a growth segment. It is competing for only remnant demand while the class itself undergoes broader restrictions and risk mitigation. The main “value” is not clinical superiority; it is legacy residue.
Patent and exclusivity reality check for DARVOCET-N 100
Why patent value is limited in this case
Even when patents exist, regulatory withdrawal controls commercial viability more than exclusivity does. For an investable branded product, the core question is whether there is a live patent estate that supports future U.S. supply. With propoxyphene removed from the U.S. market, the effective time horizon for patent monetization shrinks to near-zero for U.S. commercialization.
Investment implication: treat DARVOCET-N 100 as a legacy and legal residual asset, not as an R&D-backed IP growth story.
Legal and risk: the dominant driver for an opioid legacy brand
How does litigation risk shape the investment scenario?
Opioid-related products have historically faced multi-year litigation, including claims related to marketing, safety, and downstream harm. For propoxyphene-containing brands, the investment impact tends to show up in:
- Settlements and judgments
- Bankruptcy and restructuring outcomes
- Payment schedules and covenants affecting remaining operating assets
For an investor, the valuation work collapses to: expected settlement cash flows versus remaining corporate survival and asset coverage.
Operational focus: legal exposure analysis, not clinical pipeline logic.
Investment scenario modeling framework for DARVOCET-N 100
What is the most realistic scenario set?
Given the U.S. withdrawal posture, an investment case for DARVOCET-N 100 fits three practical scenarios:
-
Legacy residue scenario (time-limited cash flows)
- Value comes from residual inventory, residual international volumes (if any), and any remaining authorized supply chain activity.
- Downside: enforcement and attrition.
-
Litigation-settlement scenario (financials dominated by legal outcomes)
- Value comes from expected settlements or resolution structures tied to the underlying corporate/legal docket.
- Upside: structured settlements under more favorable terms.
- Downside: adverse judgments, higher payout schedules, or asset divestiture.
-
Off-market liquidation scenario (asset sale approach)
- Value comes from selling remaining inventory rights, brand assets, or distribution rights where permissible.
- Downside: discounting due to regulatory constraints and low liquidity.
Key business fundamentals: what to measure
What metrics actually drive returns for this type of asset?
For DARVOCET-N 100, the business fundamentals shift from standard pharma KPIs to:
- Regulatory status compliance in relevant jurisdictions (U.S. is decisive here). [1]
- Residual supply availability (how much remains in legitimate channels).
- Litigation docket progress and settlement ranges (cash flow timing and probability weighting).
- Corporate asset coverage supporting any legal payment obligations.
Where value hides and where it breaks
What drives upside, if any?
- Non-U.S. regulatory allowances (if propoxyphene remains authorized in specific markets)
- Favorable settlement structures that reduce total cost or accelerate cash receipts
- Residual market demand that persists longer than expected due to inertia in prescribing and patient switching
What drives downside, decisively?
- Regulatory enforcement tightening that suppresses residual legitimate commerce
- Adverse legal outcomes increasing total settlement/judgment burdens
- Time discounting from slow docket resolution and asset liquidation
Bottom-line investment posture
DARVOCET-N 100 is not a conventional “brand growth” investment. Its economics are governed by a regulatory shutdown of the underlying active ingredient in the U.S. and the downstream impacts of opioid-related legal exposure. The investable path is therefore a legacy risk-finance position: estimate the residual cash flows and net legal settlement economics, then discount for time-to-resolution and enforceability constraints.
Key Takeaways
- DARVOCET-N 100 is a propoxyphene-acetaminophen opioid brand; U.S. viability ended after FDA withdrawal action for propoxyphene in 2009. [1]
- The investment case is dominated by legacy residue and legal settlement economics, not by standard revenue growth or pipeline-driven fundamentals.
- Patent exclusivity has limited practical value once access to market supply is gone; valuation hinges on regulatory status, residual supply, and litigation outcomes.
- Returns are shaped by time-to-docket resolution, settlement probability, and corporate asset coverage, with strong downside sensitivity to adverse outcomes.
FAQs
1) Is DARVOCET-N 100 still marketed in the U.S.?
Propoxyphene-containing products were withdrawn from the U.S. market following FDA action, making DARVOCET-N 100’s U.S. commercialization nonviable in the standard sense. [1]
2) What is the main safety driver behind the product’s exit?
FDA action for propoxyphene was based on safety risks, including cardiac concerns such as QT prolongation. [1]
3) Does the brand have ongoing commercialization potential in the U.S.?
No. Post-withdrawal, U.S. growth is structurally capped, and any remaining activity is legacy and enforcement constrained. [1]
4) Where does investor value come from then?
Value comes from residual cash flows (if any) and expected legal settlement economics tied to the underlying opioid/propoxyphene exposure.
5) Can patent life create a new investment catalyst?
Not in a meaningful way for U.S. commercialization once propoxyphene was withdrawn; exclusivity cannot restore market access where regulators removed the product class. [1]
References
- U.S. Food and Drug Administration. (2009). FDA requests withdrawal of propoxyphene products (Darvon and Darvocet) from the market. FDA Drug Safety Communication. [Online] Available at: https://www.fda.gov/drugs/drug-safety-and-availability/changes-drug-labeling-ndas-and/or-withdrawal-products-market
More… ↓
