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Last Updated: January 20, 2025

DOLENE AP-65 Drug Patent Profile


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Which patents cover Dolene Ap-65, and when can generic versions of Dolene Ap-65 launch?

Dolene Ap-65 is a drug marketed by Lederle and is included in one NDA.

The generic ingredient in DOLENE AP-65 is acetaminophen; propoxyphene hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene hydrochloride profile page.

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Summary for DOLENE AP-65
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 11
DailyMed Link:DOLENE AP-65 at DailyMed
Drug patent expirations by year for DOLENE AP-65

US Patents and Regulatory Information for DOLENE AP-65

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lederle DOLENE AP-65 acetaminophen; propoxyphene hydrochloride TABLET;ORAL 085100-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory of the Pharmaceutical Industry: Insights Relevant to DOLENE AP-65

Introduction

The pharmaceutical industry is a complex and dynamic market influenced by various factors, including technological advancements, regulatory changes, and shifting consumer needs. To understand the market dynamics and financial trajectory relevant to a specific drug like DOLENE AP-65, it is crucial to analyze broader trends within the pharmaceutical sector.

Market Segmentation: Small Molecule Drugs vs. Biological Products

The pharmaceutical market is broadly segmented into small molecule drugs and biological products. Between 2017 and 2022, the market saw significant shifts in these segments.

  • Small Molecule Drugs: These drugs experienced a relatively flat expenditure trend, with spending remaining around $360 billion per year. However, the number of prescriptions increased by 19.2% during this period, indicating a drop in the price per small molecule drug[1].
  • Biological Products: In contrast, biological products saw a substantial increase in spending, rising by 55% between 2017 and 2022. This growth was driven by higher spending per prescription rather than an increase in the number of prescriptions[1].

Competition in the Pharmaceutical Market

Competition plays a critical role in shaping the market dynamics.

  • Single Manufacturer vs. Multiple Manufacturers: In 2022, 43% of small molecule drugs had a single manufacturer, accounting for 65% of small molecule drug expenditures. This indicates that drugs with a single manufacturer dominate the market in terms of spending[1].
  • Market Concentration: The number of small molecule drugs with 6+ manufacturers increased, while those with a single manufacturer declined over time. This trend suggests a more competitive landscape for some segments of the market[1].

Specialty Drugs Market

Specialty drugs, which include many biological products, have seen significant growth.

  • Expenditure and Prescriptions: Total inflation-adjusted expenditures on specialty drugs grew from $226 billion in 2017 to $316 billion in 2022, a 39.9% increase. Despite this, the number of specialty prescriptions decreased by 6.2% during the same period, leading to a 49.2% increase in spending per specialty prescription[1].
  • Shift from Small Molecule to Biological Products: The share of specialty drug spending on small molecule drugs decreased from 50% to 40% between 2017 and 2022, while the share on biological products increased, reflecting a growing dominance of biological products in the specialty drug market[1].

Emerging Market Opportunities: Weight Loss Drugs

One of the most significant emerging market opportunities is in weight loss drugs, particularly those targeting obesity.

  • Market Size and Potential: Weight loss drugs, such as GLP-1s (e.g., Wegovy and Zepbound), represent a massive market opportunity, estimated to be around $100 billion to $150 billion annually in the U.S. alone. Globally, the potential is even larger, given the high prevalence of obesity[3].
  • Growth Drivers: The rapid scaling of these drugs is driven by high patient demand, significant weight reduction benefits (15% to 20% weight loss), and minimal side effects. This market is expected to grow rapidly, unlike some other medications that take decades to reach peak penetration[3].

Financial Trajectory and Investor Perspectives

The financial trajectory of pharmaceutical companies, especially those involved in emerging markets like weight loss drugs, is influenced by several factors.

  • Valuations and Growth Prospects: Companies like Eli Lilly, which have a strong presence in the weight loss and diabetes markets, are valued highly based on their long-term growth prospects. Despite near-term valuations, these companies are expected to see significant growth in sales and earnings over the next decade[3].
  • Market Reactions and Competitive Impact: The introduction of new weight loss drugs has already started to impact other obesity-related treatments, such as bariatric surgeries. This shift can lead to changes in market valuations for companies involved in these alternative treatments[3].

Impact on Related Markets

The emergence of effective weight loss drugs can have a ripple effect on various related markets.

  • Bariatric Surgeries: The demand for bariatric surgeries is expected to decrease as more patients opt for pharmaceutical treatments. This could impact medical device companies that rely on these surgeries as part of their business[3].
  • Healthcare Landscape: The long-term impact of these drugs will reshape aspects of the healthcare landscape, potentially reducing the need for other obesity-related treatments and altering the business models of companies in this space[3].

Key Takeaways

  • The pharmaceutical market is segmented into small molecule drugs and biological products, with biological products showing significant growth.
  • Competition in the market is evolving, with more drugs having multiple manufacturers.
  • Specialty drugs, particularly biological products, are driving expenditure growth.
  • Emerging markets like weight loss drugs offer substantial growth opportunities.
  • Financial trajectories of pharmaceutical companies are influenced by long-term growth prospects and market reactions to new treatments.

FAQs

What is the current trend in spending on small molecule drugs versus biological products?

Spending on small molecule drugs has remained relatively flat, while spending on biological products has increased significantly, driven by higher spending per prescription.

How has the competition in the pharmaceutical market changed over time?

The number of small molecule drugs with 6+ manufacturers has increased, while those with a single manufacturer have declined, indicating a more competitive landscape.

What is the estimated market size for weight loss drugs in the U.S.?

The estimated market size for weight loss drugs in the U.S. is around $100 billion to $150 billion annually.

How are weight loss drugs impacting other obesity-related treatments?

Weight loss drugs are expected to reduce the demand for bariatric surgeries and potentially alter the business models of companies involved in other obesity-related treatments.

What are the long-term growth prospects for companies involved in the weight loss drug market?

Companies like Eli Lilly are expected to see significant growth in sales and earnings over the next decade, driven by the high demand and effectiveness of these drugs.

Sources

  1. Competition in Prescription Drug Markets, 2017-2022 - ASPE
  2. Market Intel Exchange - Academy Financial, Inc.
  3. A Multi-Billion-Dollar Drug Market - Baron Funds
  4. Antimicrobial Drugs Market Returns Analysis - ASPE

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