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Last Updated: December 22, 2024

ONFI Drug Patent Profile


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

Onfi is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs.

The generic ingredient in ONFI is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Onfi

A generic version of ONFI was approved as clobazam by AMNEAL on October 22nd, 2018.

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

See drug prices for ONFI

Pharmacology for ONFI

US Patents and Regulatory Information for ONFI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lundbeck Pharms Llc ONFI clobazam SUSPENSION;ORAL 203993-001 Dec 14, 2012 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lundbeck Pharms Llc ONFI clobazam TABLET;ORAL 202067-003 Oct 21, 2011 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lundbeck Pharms Llc ONFI clobazam TABLET;ORAL 202067-001 Oct 21, 2011 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

ONFI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Onfi (Clobazam)

Introduction to Onfi

Onfi, known generically as clobazam, is a prescription medication approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. It belongs to the benzodiazepine anticonvulsants drug class and is classified as a Schedule IV controlled substance[2][4].

Market Approval and Usage

Onfi was approved by the FDA for its specific indication, making it a crucial treatment option for patients with LGS. The drug is available in oral tablet and oral liquid suspension forms, catering to different patient needs[1][2].

Pricing and Cost Factors

The cost of Onfi can vary significantly based on several factors:

  • Dosage and Form: The price differs for 10 mg and 20 mg tablets, as well as for the oral liquid suspension. For example, 100 tablets of 10 mg Onfi can cost around $3,149, while 100 tablets of 20 mg can cost approximately $6,288. The oral liquid suspension (2.5 mg/mL) costs about $1,659 for 120 mL[2].
  • Insurance Coverage: The cost with insurance depends on the specific plan benefits, prior authorization requirements, and copays. Without insurance, the cash price is substantially higher[1][2].
  • Pharmacy and Location: Prices can vary between pharmacies, making it advisable to compare prices at different locations[2].
  • Generic vs. Brand Name: The generic version of clobazam is significantly cheaper, with 100 tablets of 10 mg costing around $204 and 100 tablets of 20 mg costing about $398. The generic oral suspension costs approximately $45.20 for 120 mL[2][4].

Generic Competition

The introduction of generic versions of clobazam has significantly impacted the market dynamics. Companies like Upsher-Smith have launched generic clobazam tablets and oral suspension, providing patients with a more affordable alternative to the brand-name Onfi. This competition has driven down the costs for patients and has likely affected the revenue of the brand-name drug[4].

Financial Assistance Programs

To make Onfi more accessible, various financial assistance programs are available:

  • Copay Card: Lundbeck offers a Copay Card that can help reduce out-of-pocket costs for patients with commercial insurance.
  • Patient Assistance Program: Patients without insurance may qualify for financial assistance through the Lundbeck Patient Assistance Program.
  • Free Trial Offer: A free 14-day trial offer is also available for new patients[2].

Market Sales and Revenue

Historically, the clobazam market has seen substantial sales. For the 12 months ending August 2018, the clobazam tablet market had U.S. sales of approximately $594 million, and the oral suspension market had sales of about $255 million[4].

Impact of Generic Entry

The entry of generic clobazam has likely reduced the market share and revenue of the brand-name Onfi. Generic drugs, being cheaper, attract more price-sensitive consumers, which can lead to a decline in sales for the brand-name version. However, the exact current revenue figures for Onfi post-generic entry are not provided in the available sources.

Competitive Landscape

Onfi competes with other seizure medications such as Vimpat. The cost comparison between these drugs depends on factors like the form of the drug, treatment length, and available payment assistance programs. For instance, Vimpat is available in oral tablets, oral solution, and intravenous (IV) infusion, with the IV infusion typically being more expensive than oral forms[1].

Regulatory and Patent Considerations

The patent expiration for brand-name drugs allows multiple manufacturers to produce generic versions, increasing competition and reducing prices. Onfi’s patent status and any regulatory exclusivities would influence its market position and pricing strategy[1].

Abuse and Dependence

While Onfi is less commonly abused compared to other benzodiazepines, it still carries the risk of abuse and dependence. This aspect can impact its prescription rates and overall market dynamics, as healthcare providers may opt for alternative treatments with lower abuse potential[5].

Key Takeaways

  • Pricing Variability: The cost of Onfi varies widely based on dosage, form, insurance coverage, and pharmacy.
  • Generic Competition: Generic clobazam has significantly reduced costs for patients and impacted the brand-name drug's revenue.
  • Financial Assistance: Various programs are available to help patients afford Onfi.
  • Market Sales: The clobazam market has seen substantial sales, but generic entry has likely reduced brand-name Onfi's market share.
  • Regulatory Factors: Patent status and regulatory exclusivities influence the drug's market position.

FAQs

How much does Onfi cost without insurance?

The cash price for Onfi without insurance can be roughly $3,149 for 100 tablets of the 10 mg strength and $6,288 for 100 tablets of the 20 mg strength. The oral liquid suspension costs about $1,659 for 120 mL[2].

What are the generic prices for Onfi?

Generic clobazam tablets cost around $204 for 100 tablets of 10 mg and $398 for 100 tablets of 20 mg. The generic oral suspension costs approximately $45.20 for 120 mL[2].

How can I save money on Onfi prescriptions?

You can save money by using Optum Perks coupons, getting a 90-day supply if approved by your insurance, and utilizing financial assistance programs like Lundbeck's Copay Card and Patient Assistance Program[1][2].

What is Onfi approved to treat?

Onfi is approved to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older[2].

Can Onfi be abused?

Yes, Onfi (clobazam) is a Schedule IV controlled substance and carries the risk of abuse and dependence, although it is less commonly abused compared to other benzodiazepines[5].

Sources

  1. Medical News Today: Onfi and cost: Reducing long-term drug costs and more.
  2. Drugs.com: How much does Onfi cost without insurance?
  3. Jazz Pharmaceuticals: Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results and Raises 2023 Full Year Financial Guidance.
  4. Biospace: Upsher-Smith Launches Generic Version Of Onfi® (clobazam), CIV.
  5. Greenhouse Treatment: Can Onfi (Clobazam) Be Abused? Uses & Side Effects.

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