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Last Updated: March 14, 2025

PEDIAMYCIN Drug Patent Profile


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When do Pediamycin patents expire, and when can generic versions of Pediamycin launch?

Pediamycin is a drug marketed by Ross Labs and Arbor Pharms Llc and is included in three NDAs.

The generic ingredient in PEDIAMYCIN is erythromycin ethylsuccinate. There are one hundred and three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the erythromycin ethylsuccinate profile page.

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Summary for PEDIAMYCIN
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 54
Patent Applications: 1,608
DailyMed Link:PEDIAMYCIN at DailyMed
Drug patent expirations by year for PEDIAMYCIN

US Patents and Regulatory Information for PEDIAMYCIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Arbor Pharms Llc PEDIAMYCIN erythromycin ethylsuccinate SUSPENSION;ORAL 062304-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ross Labs PEDIAMYCIN erythromycin ethylsuccinate GRANULE;ORAL 062305-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ross Labs PEDIAMYCIN erythromycin ethylsuccinate SUSPENSION/DROPS;ORAL 062305-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ross Labs PEDIAMYCIN erythromycin ethylsuccinate TABLET, CHEWABLE;ORAL 062306-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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 4 of 4 entries

Market Dynamics and Financial Trajectory for Pediamycin

Overview of Pediamycin

Pediamycin, known generically as erythromycin, is a macrolide antibiotic used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria and is commonly prescribed for infections such as pneumonia, Legionnaires' disease, and certain types of skin infections[4].

Market Context

U.S. Pharmaceutical Market

The U.S. pharmaceutical market, within which Pediamycin operates, is experiencing significant growth. The market size was USD 602.19 billion in 2023 and is projected to reach USD 1,093.79 billion by 2033, growing at a CAGR of 6.15% from 2024 to 2033. This growth is driven by a robust pipeline of specialty drugs and an increasing number of brand name pharmaceutical manufacturers[1].

Product Segment

Antibiotics Market

Pediamycin falls under the antibiotics segment of the pharmaceutical market. Antibiotics are a crucial part of the pharmaceutical landscape, especially given the rising prevalence of bacterial infections. However, the antibiotics market faces challenges such as antibiotic resistance and stringent regulatory approvals.

Prescription vs. OTC

Pediamycin is primarily a prescription drug, which dominates the pharmaceutical market with a revenue share of 88.23% in 2023. The prescription segment is characterized by drugs prescribed by doctors, purchased at pharmacies, and regulated by the FDA through the New Drug Application (NDA) process[1].

Pricing Dynamics

Price Increases and Competition

The prices of brand-name prescription drugs, including antibiotics like Pediamycin, have seen significant increases. Between 2015 and 2017, 78% of drugs available since 2012 saw price increases of more than 50%, with 44% more than doubling in price[3].

The current rebate system in the U.S. pharmaceutical market incentivizes high list prices and greater reliance on rebates, which can increase overall costs. This system affects the pricing of drugs like Pediamycin, making them more expensive for consumers[3].

Generic and Biosimilar Competition

While Pediamycin itself is not a biosimilar, the increasing approval and market presence of biosimilars and generic drugs can impact the pricing and market share of brand-name antibiotics. Generic prescribing has become more prevalent, which can reduce the market share of brand-name drugs. However, the impact on Pediamycin specifically would depend on the availability of generic or biosimilar alternatives[1][3].

Financial Trajectory

Revenue and Market Share

The financial trajectory of Pediamycin is influenced by its market position within the antibiotics segment. As a well-established antibiotic, Pediamycin generates significant revenue, although exact figures are not publicly disclosed.

The branded segment, which includes Pediamycin, dominated the pharmaceutical market with a revenue share of 68.19% in 2023. However, the increasing competition from generics and biosimilars could affect the long-term revenue growth of brand-name antibiotics[1].

Cost and Profitability

The profitability of Pediamycin is tied to its pricing, market demand, and competition. High prices for brand-name drugs, including antibiotics, contribute to the overall profitability of pharmaceutical companies. However, the need to balance pricing with market competition and regulatory pressures can impact profitability.

For instance, the high and growing costs of brand-name drugs, despite government-protected market exclusivity, suggest that companies must navigate complex pricing strategies to maintain profitability[3].

Regulatory Environment

FDA Approvals and Compliance

Pediamycin, like all prescription drugs, must comply with FDA regulations. The FDA's approval process ensures the safety and efficacy of drugs before they enter the market. Any changes in FDA policies or regulations can impact the market dynamics and financial trajectory of Pediamycin[1].

Consumer and Healthcare Trends

Increasing Demand for Cost-Effective Alternatives

There is a growing trend towards cost-effective alternatives in the pharmaceutical market. Consumers and healthcare providers are increasingly looking for affordable options, which can include over-the-counter (OTC) drugs or generic alternatives. This trend could influence the market share and revenue of Pediamycin if generic or OTC versions become more prevalent[1].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges facing antibiotics like Pediamycin is the rising issue of antibiotic resistance. This can reduce the effectiveness of the drug over time and necessitate the development of new antibiotics. Companies must invest in research and development to address this challenge[4].

Pediatric Market

Pediamycin is also used in pediatric patients, and the rising number of medication approvals for this population presents an opportunity for growth. For example, the FDA approval of new medications for pediatric patients, such as Pfizer's NGENLA, indicates a growing market segment that Pediamycin could tap into[1].

Key Takeaways

  • Market Growth: The U.S. pharmaceutical market, including the segment for antibiotics like Pediamycin, is expected to grow significantly.
  • Pricing Dynamics: High prices and the rebate system can impact the financial trajectory of brand-name drugs.
  • Competition: Generic and biosimilar competition can affect market share and revenue.
  • Regulatory Compliance: FDA approvals and regulations are crucial for the continued market presence of Pediamycin.
  • Consumer Trends: Increasing demand for cost-effective alternatives could influence market dynamics.

FAQs

1. What is Pediamycin used for? Pediamycin, or erythromycin, is used to treat a wide variety of bacterial infections, including pneumonia and certain skin infections.

2. How does the U.S. pharmaceutical market impact Pediamycin? The U.S. pharmaceutical market's growth, driven by specialty drugs and brand name manufacturers, influences the overall market dynamics and financial trajectory of Pediamycin.

3. What are the key challenges facing Pediamycin? Key challenges include antibiotic resistance, high pricing, and competition from generics and biosimilars.

4. How does the FDA approval process affect Pediamycin? The FDA approval process ensures the safety and efficacy of Pediamycin, and any changes in FDA policies can impact its market presence.

5. What are the opportunities for growth for Pediamycin? Opportunities include the growing pediatric market and the need for new antibiotics to address antibiotic resistance.

Sources

  1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
  2. Financial Data for Six Pharmaceutical Companies - IP Mall
  3. Trends in Prices of Brand-Name Prescription Drugs in the United States - JAMA Network
  4. Pediamycin Suspension - Uses, Side Effects, and More - WebMD
  5. Alternative Approaches to Reducing Prescription Drug Prices - Congressional Budget Office

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