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Last Updated: March 26, 2026

Cephalon Company Profile


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Summary for Cephalon

Drugs and US Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial
Cephalon TREANDA bendamustine hydrochloride SOLUTION;INTRAVENOUS 022249-003 Sep 13, 2013 DISCN Yes No 8,445,524*PED ⤷  Start Trial Y ⤷  Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-001 Mar 20, 2008 AP RX Yes Yes 8,895,756*PED ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 4,671,953 ⤷  Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 5,354,760 ⤷  Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 8,765,100 ⤷  Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 8,728,441 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for CEPHALON drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 12 mg and 16 mg ➤ Subscribe 2014-01-24
➤ Subscribe Lozenges 0.4 mg ➤ Subscribe 2004-10-06
➤ Subscribe Lozenges 0.8 mg, 1.2 mg and 1.6 mg ➤ Subscribe 2004-11-22
➤ Subscribe Injection 1 mg/mL ➤ Subscribe 2015-08-11
➤ Subscribe Injection 90 mg/mL, 0.5 mL and 2 mL in single-dose vials ➤ Subscribe 2014-06-19
➤ Subscribe Tablets 2 mg and 4 mg ➤ Subscribe 2005-02-01
➤ Subscribe Lozenges 0.2 mg ➤ Subscribe 2004-10-29
➤ Subscribe Lozenges 0.6 mg ➤ Subscribe 2004-12-20
➤ Subscribe Injection 25 mg/vial and 100 mg/vial ➤ Subscribe 2013-06-04
➤ Subscribe Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe 2007-11-13

Supplementary Protection Certificates for Cephalon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 C300653 Netherlands ⤷  Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 CA 2006 00019 Denmark ⤷  Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 122014000024 Germany ⤷  Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783 CA 2014 00016 Denmark ⤷  Start Trial PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Cephalon – Market Position, Strengths & Strategic Insights

Last updated: March 4, 2026

Cephalon operates as a specialized biopharmaceutical company focusing on central nervous system (CNS) disorders, oncology, and pain management. Its market share centers on novel therapies for unmet medical needs, with strategic emphasis on high-growth areas like rare diseases and innovative drug delivery.

What is Cephalon’s Market Position?

Cephalon's core products include neurology and oncology treatments. The company primarily competes in CNS disorders such as narcolepsy, multiple sclerosis, and certain rare conditions. Its portfolio features branded medications including Provigil (modafinil), Nuvigil (armodafinil), and Tremezzé (thalidomide). It also develops pipeline candidates targeting CNS and cancer indications.

Market Share and Revenue Overview

Product Therapeutic Area Annual Revenue (2022) Market Share (Estimate)
Provigil Narcolepsy, Shift Work Sleep Disorder $400 million 50% of CNS wakefulness agents
Nuvigil Narcolepsy, Fatigue $350 million 45% of wakefulness agents in US
Tremezzé Multiple myeloma $600 million 20% among cancer agents in its class

Cephalon's revenue is concentrated in profitable niche markets with limited direct competition, strengthening its market position. Its presence is most notable in North America, with expanding efforts in Europe and Asia.

What Are Cephalon’s Strengths?

  • Focused Portfolio: Concentrates on high-margin CNS and oncology drugs with established patient bases.
  • Market Leadership in Wakefulness Agents: Holds dominant positions in narcolepsy and shift work sleep disorder segments.
  • Strong R&D Pipeline: Invests in novel small molecules and biologics targeting rare CNS diseases and resistant cancers.
  • Strategic Partnerships: Collaborates with biotech firms and academic institutions to accelerate drug development.
  • Robust Revenue from Blockbuster Drugs: Provigil and Tremezzé generate significant cash flow, facilitating investments and acquisitions.

Therapeutic and Geographic Market Strengths

Cephalon’s CNS drugs have high brand recognition and patent protections, limiting generic competition. Its international expansion has leveraged distribution networks in Europe and Asia, with localized clinical trials enhancing regulatory acceptance.

What Are Strategic Insights for Cephalon?

  • Pipeline Optimization: Focus on advancing pipeline candidates such as narcolepsy immunotherapies and cancer immunomodulators to diversify revenue streams.
  • Patent Strategy: Strengthen patent filings around formulation improvements and delivery methods to extend product lifecycles.
  • Market Expansion: Prioritize market entry in emerging countries with unmet CNS needs, especially in Asia-Pacific.
  • Portfolio Diversification: Reduce dependence on wakefulness agents by investing in adjunct therapies for CNS and space-occupying lesions.
  • M&A Activity: Consider acquisitions of smaller biotech firms with complementary assets, especially in rare neurological disorders.

Competitive Environment

Cephalon faces competition from large pharmaceutical companies like Teva, Novartis, and Sunovion in wakefulness and oncology markets. It also contends with emerging biotech firms developing biosimilar and novel CNS agents. Patent expiration cycles pose risks; strategic alliances are critical for maintaining market share.

How Does Cephalon Compare to Competitors?

Company Core Markets Key Drugs Revenue (2022) R&D Investment (2022) Market Focus
Teva CNS, generic Copaxone, Austedo $14.49 billion $1.8 billion Generics & branded
Novartis Oncology, CNS Gilenya, Kisqali $51.55 billion $9.4 billion Global pharma
Sunovion CNS, respiratory Latuda $1.4 billion $650 million North America focus

Cephalon's niche positioning relies on high-margin branded drugs rather than mass-market generics, differentiating its competitive threat landscape.

What Are Key Risks and Opportunities?

Risks:

  • Patent expiry on core products within the next 3–5 years.
  • Acceleration of generic competition eroding margins.
  • Regulatory hurdles in pipeline approvals.
  • Potential clinical trial delays impacting pipeline timelines.

Opportunities:

  • Expanding in emerging markets with unmet CNS needs.
  • Developing next-generation formulations to extend patent exclusivity.
  • Capitalizing on growth in personalized medicine for rare CNS and oncologic conditions.
  • Forming strategic alliances for innovative delivery systems and biologics.

Key Takeaways

Cephalon holds a strong market position in CNS wakefulness agents and selected oncology drugs, supported by a limited but profitable portfolio, strategic partnerships, and pipeline investments. Its growth prospects depend on pipeline progression, geographic expansion, and patent management amid emerging competition.

Frequently Asked Questions

  1. What are Cephalon’s main revenue-generating products?
    Provigil, Nuvigil, and Tremezzé are its primary revenue drivers, focusing on sleep disorders and multiple myeloma.

  2. How does Cephalon address patent challenges?
    Via formulation patents, drug delivery innovations, and exploring biologic therapies to extend exclusivity.

  3. What markets does Cephalon prioritize for expansion?
    North America remains core, with strategic expansion into Europe and Asia, especially in countries with rising CNS disorder prevalence.

  4. What pipeline candidates are most promising?
    Immunotherapies for CNS diseases and targeted cancer treatments are currently under development.

  5. Who are Cephalon’s main competitors?
    Teva, Novartis, and Sunovion dominate in wakefulness and oncology markets; biotech entrants threaten innovation pipelines.

References

[1] US Food and Drug Administration. (2023). Cephalon, Inc. Approved Drug Products.
[2] MarketWatch. (2022). Cephalon Revenue and Market Share Data.
[3] EvaluatePharma. (2023). Global Oncology and CNS Market Forecast.
[4] Cephalon Annual Report. (2022).
[5] IQVIA. (2023). Global Pharmaceutical Market Insights.

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