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Last Updated: April 26, 2025

OMNIPEN-N Drug Patent Profile


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When do Omnipen-n patents expire, and when can generic versions of Omnipen-n launch?

Omnipen-n is a drug marketed by Wyeth Ayerst and is included in two NDAs.

The generic ingredient in OMNIPEN-N is ampicillin sodium. There are seventy drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omnipen-n

A generic version of OMNIPEN-N was approved as ampicillin sodium by SANDOZ on February 19th, 1987.

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Summary for OMNIPEN-N
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 78
Patent Applications: 1,730
DailyMed Link:OMNIPEN-N at DailyMed
Drug patent expirations by year for OMNIPEN-N

US Patents and Regulatory Information for OMNIPEN-N

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Wyeth Ayerst OMNIPEN-N ampicillin sodium INJECTABLE;INJECTION 060626-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Wyeth Ayerst OMNIPEN-N ampicillin sodium INJECTABLE;INJECTION 060626-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Wyeth Ayerst OMNIPEN-N ampicillin sodium INJECTABLE;INJECTION 062718-002 Dec 16, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Wyeth Ayerst OMNIPEN-N ampicillin sodium INJECTABLE;INJECTION 062718-005 Dec 16, 1986 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 OMNIPEN-N

Introduction

OMNIPEN-N, an intravenous form of the antibiotic ampicillin, is a crucial medication in the treatment of various bacterial infections. To understand its market dynamics and financial trajectory, it is essential to delve into several key aspects, including its usage, market trends, and the broader antibiotic market context.

Usage and Clinical Significance

Treatment Indications

OMNIPEN-N is used to treat a wide range of bacterial infections. It is a penicillin-type antibiotic that works by stopping the growth of bacteria, making it effective against infections such as pneumonia, bronchitis, and urinary tract infections[5].

Side Effects and Safety Profile

While OMNIPEN-N is generally well-tolerated, it can cause side effects such as nausea, vomiting, diarrhea, and in some cases, more severe conditions like a C. difficile infection. The safety profile is a critical factor in its prescription and use[2][5].

Market Trends in Antibiotics

Generic vs. Branded Antibiotics

The antibiotic market is predominantly driven by generic, off-patent products. These low-priced generics account for the majority of antibiotic sales, with top-selling antibiotics like amoxicillin, vancomycin, and penicillin G being generic versions[3].

Revenue and Sales

The global annual revenue for new antibiotic drugs launched between 2010 and 2020 averaged around $46 million. However, generic antibiotics dominate the market, with drugs like Zosyn and Amoxicillin generating significant revenue. For instance, in 2022, Zosyn generated $256.6 million in annual revenue, while generic amoxicillin generated $213.2 million[3].

Financial Trajectory of OMNIPEN-N

Revenue Potential

Given that OMNIPEN-N is a generic antibiotic, its revenue potential is influenced by the broader market dynamics of generic antibiotics. The revenue for generic antibiotics is generally lower compared to branded drugs but can be substantial due to high volume sales.

Market Competition

The antibiotic market is highly competitive, with many generic options available. OMNIPEN-N competes with other penicillin-type antibiotics, both branded and generic. The competition affects pricing and market share, making it challenging for any single antibiotic to dominate the market[3].

Impact of Regulatory and Economic Factors

Economic Incentives for Antibiotic Development

The development of new antibiotics faces significant economic challenges. The average cost to bring a new antibiotic to market is estimated to be in the range of $2.0 to $3.5 billion, with an internal rate of return (IRR) target of around 11% to attract private sector investment[3].

Public Health Costs

The economic burden of antibiotic resistance is substantial, with estimates suggesting that it could cost health systems up to $28.9 billion per year by 2050 if current trends continue. This highlights the need for continued investment in antibiotic development and stewardship[3].

Regional Market Dynamics

Global and Local Markets

The global antibiotic market is diverse, with different regions having different market dynamics. For example, the Japanese market for breast cancer treatments, which includes some antibiotics, is expected to grow significantly, but this does not directly translate to the OMNIPEN-N market. However, it indicates a growing demand for antibiotics in various therapeutic areas[4].

Telemedicine and Pandemic Impact

COVID-19 Pandemic

The COVID-19 pandemic had a significant impact on the prescription and dispensing of medications, including antibiotics. While there was an initial decline in prescriptions due to lockdowns and healthcare disruptions, telemedicine played a crucial role in maintaining access to medications. This trend, however, is more relevant to stimulant prescriptions and other controlled substances rather than antibiotics like OMNIPEN-N[1].

Patient Demographics and Prescription Trends

Prescription Patterns

The prescription patterns for antibiotics like OMNIPEN-N are influenced by patient demographics and clinical needs. For instance, the age and sex distribution of patients can affect the volume of prescriptions. However, specific data on OMNIPEN-N prescription trends by demographics is not readily available, but it is likely to follow broader antibiotic prescription patterns[1].

Key Takeaways

  • Market Dominance of Generics: The antibiotic market is largely driven by generic, off-patent products.
  • Revenue Potential: OMNIPEN-N, as a generic antibiotic, has a significant revenue potential but faces intense competition.
  • Economic Challenges: The development of new antibiotics is economically challenging, requiring substantial investment.
  • Public Health Impact: The economic burden of antibiotic resistance underscores the need for continued investment in antibiotic development.
  • Regional Dynamics: Market dynamics vary by region, with different growth prospects and challenges.

FAQs

What is OMNIPEN-N used for?

OMNIPEN-N is an intravenous form of the antibiotic ampicillin, used to treat a wide range of bacterial infections.

How does OMNIPEN-N compare to other antibiotics in terms of revenue?

As a generic antibiotic, OMNIPEN-N's revenue is influenced by the broader market dynamics of generic antibiotics, which generally generate lower revenue compared to branded drugs but can achieve substantial sales volumes.

What are the economic challenges in developing new antibiotics?

Developing new antibiotics is economically challenging, with estimated costs ranging from $2.0 to $3.5 billion and requiring an internal rate of return (IRR) target of around 11% to attract private sector investment.

How has the COVID-19 pandemic affected antibiotic prescriptions?

The pandemic had a mixed impact on prescription trends, with an initial decline followed by a rebound, but this is more relevant to controlled substances rather than antibiotics like OMNIPEN-N.

What is the public health cost of antibiotic resistance?

The economic burden of antibiotic resistance is estimated to be up to $28.9 billion per year by 2050 if current trends continue, highlighting the need for continued investment in antibiotic development and stewardship.

Sources

  1. IQVIA Report on Stimulant Trends from 2012 - 2022 - U.S. Department of Justice, Drug Enforcement Administration.
  2. Omnipen-N Intravenous: Uses, Side Effects, Interactions - WebMD.
  3. Sizing A Market Entry Reward for the Development of New Antibiotics - Harvard Kennedy School.
  4. Increasing trends of pharmaceutical payments to breast cancer specialists in Japan - PMC.
  5. Omnipen Oral: Uses, Side Effects, Interactions, Pictures - WebMD.

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