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Last Updated: December 22, 2024

DUTOPROL Drug Patent Profile


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Which patents cover Dutoprol, and when can generic versions of Dutoprol launch?

Dutoprol is a drug marketed by Concordia and is included in one NDA.

The generic ingredient in DUTOPROL is hydrochlorothiazide; metoprolol succinate. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; metoprolol succinate profile page.

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Summary for DUTOPROL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 78
Drug Prices: Drug price information for DUTOPROL
What excipients (inactive ingredients) are in DUTOPROL?DUTOPROL excipients list
DailyMed Link:DUTOPROL at DailyMed
Drug patent expirations by year for DUTOPROL
Drug Prices for DUTOPROL

See drug prices for DUTOPROL

US Patents and Regulatory Information for DUTOPROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia DUTOPROL hydrochlorothiazide; metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 021956-001 Aug 28, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia DUTOPROL hydrochlorothiazide; metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 021956-002 Aug 28, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Concordia DUTOPROL hydrochlorothiazide; metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 021956-003 Aug 28, 2006 DISCN Yes 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

DUTOPROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DUTOPROL

Introduction to DUTOPROL

DUTOPROL is a combination tablet of metoprolol succinate, a beta adrenoceptor blocker, and hydrochlorothiazide (HCTZ), a thiazide diuretic. It is indicated for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions[4].

Market Context: Antihypertensive Drugs

The global antihypertensive drugs market is expected to grow significantly, driven by the availability of a wide range of antihypertensive drugs and the development of modified-release formulations. Between 2019 and 2023, the market is projected to grow by USD 3.96 billion at a CAGR of over 2%[1].

Competitive Landscape

The antihypertensive market is highly competitive, with numerous pharmaceutical companies developing and marketing various antihypertensive drugs. The entry of follow-on or 'me-too' drugs has increased competition, reducing the period of marketing exclusivity for breakthrough drugs. This competition has led to faster entry of new drugs into the market, with the median exclusivity period dropping from 10.2 years in the 1970s to 1.2 years in the late 1990s[3].

DUTOPROL's Position in the Market

DUTOPROL, approved in 2006, is a combination therapy that offers the benefits of both a beta-blocker and a diuretic. This combination is often preferred because it can be more effective than monotherapy in controlling blood pressure. Many patients require more than one drug to achieve their blood pressure goals, making combination therapies like DUTOPROL valuable in comprehensive cardiovascular risk management[4].

Pricing and Financial Trajectory

The pricing of DUTOPROL, like many other prescription drugs, has been subject to significant fluctuations. Private equity firms have been involved in price-gouging schemes, where they acquire drugs and then sharply increase their prices. For example, the price of DUTOPROL soared by 1,057% after being acquired by a private equity firm. This trend is part of a broader issue where about 650 branded prescription drugs doubled in price between 2011 and 2015[5].

Impact of Price Increases

The substantial price increases of drugs like DUTOPROL have significant financial implications for patients, healthcare systems, and the overall economy. These price hikes can make essential medications unaffordable for many patients, leading to non-adherence to treatment and potentially worsening health outcomes. Additionally, these increases burden healthcare systems and insurance providers, contributing to the rising costs of healthcare[5].

Regulatory and Market Pressures

Regulatory bodies and market pressures are increasingly focusing on controlling drug prices. There is a growing demand for transparency in drug pricing and for measures to prevent price gouging. Pharmaceutical companies are under scrutiny to justify price increases, and there are ongoing efforts to implement policies that cap or regulate drug prices[5].

Patient Access and Affordability

The affordability of DUTOPROL is a critical issue, especially for patients who rely on this medication for long-term management of hypertension. High prices can limit access to this essential medication, highlighting the need for policies and programs that ensure affordable access to necessary drugs. This includes initiatives such as generic drug alternatives, patient assistance programs, and regulatory measures to control price increases[4][5].

Future Outlook

The future of DUTOPROL and similar antihypertensive drugs will be shaped by several factors, including regulatory changes, market competition, and the development of new therapeutic options. As the global antihypertensive market continues to grow, there will be increased focus on innovative formulations, generic alternatives, and cost-effective treatments. The financial trajectory of DUTOPROL will depend on how these factors interplay and how effectively the pharmaceutical industry can balance profitability with patient access and affordability[1][3].

Key Takeaways

  • Market Growth: The global antihypertensive drugs market is expected to grow by USD 3.96 billion between 2019 and 2023.
  • Competitive Landscape: The market is highly competitive with a significant role for follow-on drugs.
  • Pricing Issues: DUTOPROL has experienced substantial price increases, impacting patient access and affordability.
  • Regulatory Pressures: There is growing regulatory and market pressure to control drug prices.
  • Future Outlook: The future will be influenced by regulatory changes, market competition, and the development of new therapeutic options.

FAQs

Q: What is DUTOPROL used for? A: DUTOPROL is used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events.

Q: How does the combination of metoprolol and hydrochlorothiazide in DUTOPROL work? A: The combination of metoprolol succinate (a beta adrenoceptor blocker) and hydrochlorothiazide (a thiazide diuretic) works synergistically to lower blood pressure more effectively than either drug alone.

Q: Why have the prices of DUTOPROL and similar drugs increased significantly? A: The prices have increased due to private equity firms acquiring these drugs and then sharply increasing their prices as part of a broader price-gouging scheme.

Q: What are the potential side effects of DUTOPROL? A: Potential side effects include gastrointestinal issues, hypersensitivity reactions, and various other adverse reactions such as bronchospasm and worsening heart failure.

Q: How does the regulatory environment impact the pricing and availability of DUTOPROL? A: Regulatory bodies are increasingly focusing on controlling drug prices and ensuring transparency, which can impact the pricing and availability of DUTOPROL and similar medications.

Cited Sources

  1. Global Antihypertensive Drugs Market 2019-2023 - Business Wire
  2. NATIONAL QUALITY FORUM
  3. The economics of follow-on drug research and development - PubMed
  4. Dutoprol: Package Insert / Prescribing Information - Drugs.com
  5. How PE Firms Are Flipping Drugs in Price-Gouging Scheme that Cannibalizes Entire US Economy - Wolf Street

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