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Last Updated: December 22, 2024

SABRIL Drug Patent Profile


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

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

The generic ingredient in SABRIL is vigabatrin. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sabril

A generic version of SABRIL was approved as vigabatrin by ENDO OPERATIONS on April 27th, 2017.

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

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Recent Clinical Trials for SABRIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Washington University School of MedicinePhase 2
Kullasate SakpichaisakulN/A
INSYS Therapeutics IncPhase 3

See all SABRIL clinical trials

Pharmacology for SABRIL

US Patents and Regulatory Information for SABRIL

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 SABRIL vigabatrin FOR SOLUTION;ORAL 022006-001 Aug 21, 2009 AA RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lundbeck Pharms Llc SABRIL vigabatrin TABLET;ORAL 020427-001 Aug 21, 2009 AB RX Yes Yes ⤷  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

EU/EMA Drug Approvals for SABRIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ORPHELIA Pharma SAS Kigabeq vigabatrin EMEA/H/C/004534
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:Treatment in monotherapy of infantile spasms (West's syndrome).Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
Authorised no no no 2018-09-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

SABRIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SABRIL (Vigabatrin)

Introduction

SABRIL, known generically as vigabatrin, is a prescription medication used to treat specific types of seizures, including infantile spasms and refractory complex partial seizures. This article delves into the market dynamics and financial trajectory of SABRIL, highlighting key aspects such as market competition, generic erosion, financial performance, and safety considerations.

Indications and Usage

Vigabatrin is indicated for two primary uses:

  • As an adjunctive therapy for adults and children (10 years of age or older) with refractory complex partial seizures (CPS) who have not responded adequately to other treatments[4].
  • For the treatment of infantile spasms in babies from 1 month to 2 years old, if the potential benefits outweigh the risks[1].

Market Competition

The market for vigabatrin has seen significant competition with the introduction of generic versions.

  • Generic Launches: Companies like Par Pharmaceutical, Dr. Reddy’s Laboratories, and Teva Pharmaceutical Industries have launched generic versions of vigabatrin. These launches have expanded patient access to more affordable treatment options[1][3][4].
  • Market Share: The entry of generics has impacted the market share of the brand-name SABRIL. For instance, the U.S. sales of SABRIL for oral solution were approximately $329 million for the 12 months ended June 2017, which decreased with the introduction of generics[1].

Financial Performance

The financial performance of SABRIL and its generic counterparts is influenced by several factors:

  • Revenue Impact: The introduction of generic versions has led to a decline in revenue for the brand-name SABRIL. For example, Lundbeck expects increased generic erosion for SABRIL, which will impact their revenue growth[2].
  • Sales Figures: As of June 2019, the combined U.S. sales of SABRIL and its generic versions were approximately $274 million for the most recent twelve months[3].
  • Generic Sales: Teva’s launch of a generic version of SABRIL tablets in 2019 added to the competitive landscape, with SABRIL tablets having annual sales of $180 million in the U.S. as of November 2018[4].

Generic Erosion

Generic erosion is a significant factor affecting the financial trajectory of SABRIL:

  • Impact on Revenue: Lundbeck anticipates that SABRIL will face increased generic erosion, which is expected to reduce revenue growth rates. This erosion is part of the natural lifecycle of pharmaceutical products as patents expire and generics enter the market[2].
  • Market Dynamics: The presence of multiple generic manufacturers, such as Par Pharmaceutical, Dr. Reddy’s Laboratories, and Teva, further accelerates generic erosion by increasing competition and reducing prices[1][3][4].

Safety Considerations

Vigabatrin carries significant safety risks that must be considered:

  • Permanent Vision Loss: Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision. This warning is critical and must be weighed against the potential benefits of the treatment[3][4].
  • Risk Management: The risk of vision loss necessitates careful patient monitoring and adherence to treatment guidelines to minimize adverse effects.

Financial Guidance and Projections

Lundbeck’s financial guidance reflects the impact of generic competition on SABRIL:

  • Revenue Growth: The revenue growth rate for SABRIL is expected to be lower due to generic erosion. Lundbeck’s overall revenue growth is anticipated to be around four percentage points lower than at constant exchange rates due to hedging and foreign exchange impacts[2].
  • Adjusted EBITDA: Despite the challenges, Lundbeck expects adjusted EBITDA to grow by 10% to 16% at constant exchange rates in 2024, driven by investments in key assets and geographies[2].

Cash Flow and Investments

Lundbeck’s financial performance is also influenced by cash flow and investment strategies:

  • Operating Cash Flow: The company has shown strong cash generation abilities, with operating cash flows representing an inflow of 4.1 billion in 2023, reflecting strong EBIT performance and adjustments for non-cash items[2].
  • Investments: Lundbeck continues to invest in R&D and key assets, which is crucial for long-term success and innovation in the pharmaceutical industry[2].

Key Takeaways

  • Market Competition: The introduction of generic versions of vigabatrin has significantly impacted the market dynamics, offering patients more affordable treatment options.
  • Financial Performance: Generic erosion has reduced revenue for the brand-name SABRIL, but Lundbeck’s overall financial performance remains strong due to diversified product portfolios and strategic investments.
  • Safety Considerations: Vigabatrin carries a risk of permanent vision loss, which must be carefully managed.
  • Financial Guidance: Lundbeck anticipates continued growth despite generic erosion, driven by investments in key assets and geographies.

FAQs

What is SABRIL used for?

SABRIL (vigabatrin) is used as an adjunctive therapy for adults and children with refractory complex partial seizures and for the treatment of infantile spasms in babies from 1 month to 2 years old.

What are the safety risks associated with SABRIL?

Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision, which is a significant safety risk that must be carefully managed.

How has the introduction of generics affected SABRIL’s market?

The introduction of generic versions has led to increased competition, reduced prices, and a decline in revenue for the brand-name SABRIL.

What is the financial impact of generic erosion on Lundbeck?

Generic erosion is expected to reduce revenue growth rates for SABRIL, but Lundbeck’s overall financial performance remains strong due to diversified product portfolios and strategic investments.

How does Lundbeck plan to manage the financial impact of generic erosion?

Lundbeck plans to continue investing in R&D, key assets, and geographies to drive growth and innovation, despite the challenges posed by generic erosion.

Sources

  1. Endo Begins Shipment of Generic Sabril® (vigabatrin) for Oral Solution. PR Newswire.
  2. Lundbeck Full Year 2023 Financial Statement. Lundbeck.
  3. Dr. Reddy's Laboratories Announces the Launch of Vigabatrin Powder for Oral Solution, USP in the U.S. Market. BioSpace.
  4. Teva Announces U.S. Launch of a Generic Version of Sabril® (Vigabatrin). Teva Pharmaceutical Industries Ltd.

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