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Last Updated: December 22, 2024

POLYTRIM Drug Patent Profile


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When do Polytrim patents expire, and what generic alternatives are available?

Polytrim is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in POLYTRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

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Summary for POLYTRIM
Drug patent expirations by year for POLYTRIM
Drug Prices for POLYTRIM

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Recent Clinical Trials for POLYTRIM

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University of RochesterPhase 4

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US Patents and Regulatory Information for POLYTRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan POLYTRIM polymyxin b sulfate; trimethoprim sulfate SOLUTION/DROPS;OPHTHALMIC 050567-001 Oct 20, 1988 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

POLYTRIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for POLYTRIM

Introduction to POLYTRIM

POLYTRIM, a brand name for the ophthalmic solution containing polymyxin B sulfate and trimethoprim sulfate, is a sterile antimicrobial solution used for topical ophthalmic use. It is indicated for the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis and blepharoconjunctivitis, caused by susceptible strains of various microorganisms[2][3].

Approval and Manufacturing History

POLYTRIM was approved by the FDA on October 20, 1988, and was manufactured by Allergan. However, all formulations of POLYTRIM have been discontinued[1].

Market Impact of Discontinuation

The discontinuation of POLYTRIM has significant implications for the market. Patients and healthcare providers must now seek alternative treatments for the conditions POLYTRIM was used to treat. This shift can lead to increased demand for other ophthalmic anti-infectives, such as erythromycin ophthalmic and TobraDex (dexamethasone/tobramycin)[4].

Alternative Treatments

  • Erythromycin Ophthalmic: This is another prescription-only ophthalmic anti-infective used for bacterial conjunctivitis. It has a different side effect profile and may be preferred by some patients or recommended by healthcare providers based on specific patient needs[4].
  • TobraDex: A combination of dexamethasone and tobramycin, this is used for bacterial conjunctivitis, keratitis, and uveitis. It has a higher patient satisfaction rating compared to POLYTRIM and erythromycin ophthalmic[4].

Financial Implications

The financial trajectory of POLYTRIM is significantly affected by its discontinuation.

  • Revenue Loss: The discontinuation of POLYTRIM results in an immediate loss of revenue for the manufacturer. Given that the drug was available for over three decades, this loss can be substantial.
  • Cost to Patients: Prior to its discontinuation, a 10-milliliter supply of POLYTRIM ophthalmic solution cost around $84, depending on the pharmacy. Patients may now face higher costs or different pricing for alternative treatments[5].

Generic Availability and Counterfeits

Although POLYTRIM itself is no longer available, there is a warning against fraudulent online pharmacies that may attempt to sell counterfeit versions of the drug. This highlights the importance of purchasing medications from reputable sources to ensure safety and efficacy[1].

Patient and Provider Impact

  • Treatment Adjustments: Healthcare providers must adjust treatment plans to use alternative medications, which can involve additional time and resources for both providers and patients.
  • Patient Satisfaction: The discontinuation can lead to varying levels of patient satisfaction as they transition to new treatments. For example, some patients may experience different side effects or efficacy with the new medications[4].

Regulatory and Patent Considerations

  • Drug Patents and Exclusivity: The original patent for POLYTRIM would have expired long ago, given that drug patents typically last 20 years from the date of filing. However, the discontinuation is not related to patent expiration but rather to other factors such as market demand or manufacturing considerations[1].
  • Reference Listed Drug (RLD): POLYTRIM was a Reference Listed Drug, meaning any generic versions would have been compared to it for bioequivalence. The discontinuation of POLYTRIM means that any future generic versions would need to be compared to a different RLD[1].

Market Competition

The ophthalmic anti-infective market is competitive, with several drugs available for similar indications. The discontinuation of POLYTRIM opens up market share for other drugs, potentially increasing their sales and market presence.

Consumer Reviews and Ratings

POLYTRIM had an average rating of 6.0 out of 10 from patient reviews, with 50% reporting a positive effect and 50% a negative effect. In contrast, alternative treatments like TobraDex have higher patient satisfaction ratings, which could influence market dynamics and patient preferences[4].

Pricing and Patient Assistance

The cost of POLYTRIM, prior to its discontinuation, was around $84 for a 10-milliliter supply. Patients may now face different pricing for alternative treatments, and there may be a need for patient assistance programs or coupons to help manage these costs[5].

Key Takeaways

  • Discontinuation Impact: The discontinuation of POLYTRIM has significant market and financial implications, including revenue loss for the manufacturer and the need for patients to transition to alternative treatments.
  • Alternative Treatments: Other ophthalmic anti-infectives like erythromycin ophthalmic and TobraDex are available, each with their own side effect profiles and patient satisfaction ratings.
  • Regulatory Considerations: The discontinuation is not related to patent expiration but rather to other market and manufacturing factors.
  • Market Competition: The discontinuation of POLYTRIM opens up market share for other drugs, potentially increasing their sales and market presence.

FAQs

Q: Why was POLYTRIM discontinued? A: The exact reasons for the discontinuation of POLYTRIM are not specified, but it could be due to various factors such as market demand, manufacturing considerations, or strategic decisions by the manufacturer.

Q: What are the alternative treatments for conditions treated by POLYTRIM? A: Alternative treatments include erythromycin ophthalmic and TobraDex (dexamethasone/tobramycin), which are also used for bacterial conjunctivitis and other ocular infections.

Q: How does the discontinuation of POLYTRIM affect patients? A: Patients will need to transition to alternative treatments, which may have different side effects, efficacy, and costs.

Q: What was the typical cost of POLYTRIM before its discontinuation? A: The cost for a 10-milliliter supply of POLYTRIM ophthalmic solution was around $84, depending on the pharmacy.

Q: Are there any safety concerns with purchasing ophthalmic medications online? A: Yes, there is a risk of counterfeit medications when purchasing online. It is crucial to buy from reputable and valid online pharmacies to ensure safety and efficacy.

Cited Sources

  1. Drugs.com: Generic Polytrim Availability.
  2. Drugs.com: Polytrim: Package Insert / Prescribing Information.
  3. Rx AbbVie: POLYTRIM (polymyxin B sulfate and trimethoprim ophthalmic solution, USP).
  4. Drugs.com: Polytrim Alternatives Compared.
  5. Drugs.com: Polytrim Prices, Coupons, Copay Cards & Patient Assistance.

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