Cephalon Company Profile

What is the competitive landscape for CEPHALON

CEPHALON has six approved drugs.

There are eleven US patents protecting CEPHALON drugs.

There are one hundred and twenty-six patent family members on CEPHALON drugs in thirty-two countries and fourteen supplementary protection certificates in five countries.

Summary for Cephalon

International Patents:	126
US Patents:	11
Tradenames:	6
Ingredients:	4
NDAs:	6
PTAB Cases with Cephalon as patent owner:	See PTAB cases with Cephalon as patent owner

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	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998		DISCN	Yes	No
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-006	Nov 29, 2005		DISCN	No	No
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-004	Sep 13, 2013		DISCN	Yes	No	8,344,006*PED				Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	8,883,836*PED				Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	8,445,524*PED				Y

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
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998	4,863,737
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006	8,765,100
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	8,728,441
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	5,354,760
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,866,590

Paragraph IV (Patent) Challenges for CEPHALON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	1 mg/mL		2015-08-11
	Injection	90 mg/mL, 0.5 mL and 2 mL in single-dose vials		2014-06-19
	Tablets	2 mg and 4 mg		2005-02-01
	Lozenges	0.2 mg		2004-10-29
	Lozenges	0.6 mg		2004-12-20
	Injection	25 mg/vial and 100 mg/vial		2013-06-04
	Buccal Tablets	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg		2007-11-13
	Tablets	12 mg and 16 mg		2014-01-24
	Lozenges	0.4 mg		2004-10-06
	Lozenges	0.8 mg, 1.2 mg and 1.6 mg		2004-11-22

International Patents for Cephalon Drugs

Country	Patent Number	Estimated Expiration
Canada	2718939
Japan	2013100347
Portugal	1708686
South Africa	200606172
Spain	2360114
World Intellectual Property Organization (WIPO)	2005065319

Supplementary Protection Certificates for Cephalon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Ceph Intl
• Cephalon
• Cephazone Pharma

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This analysis focuses on Cephalon, a biopharmaceutical company that made significant strides in the industry before its acquisition by Teva Pharmaceutical Industries. We'll explore Cephalon's market position, strengths, and strategic insights that shaped its journey in the pharmaceutical sector.

Cephalon's Origins and Growth

Cephalon, Inc. was founded in 1987 by pharmacologist Frank Baldino, Jr., neuroscientist Michael Lewis, and organic chemist James C. Kauer[1]. The company's name, derived from the adjective "cephalic," meaning "related to the head or brain," reflected its initial focus on neurodegenerative diseases[1].

Early Focus and Strategy

In its early years, Cephalon adopted a unique strategy:

1. The company initially avoided maintaining a sales staff, managing clinical trials, or navigating the FDA approval process[1].
2. Cephalon's primary asset was its scientific expertise, which attracted investors and funded operations through research grants and contracts with larger pharmaceutical firms[1].

This approach allowed Cephalon to focus on research and development without the immediate pressure of bringing products to market.

Cephalon's Market Position

Cephalon's growth trajectory was impressive, leading to its inclusion in the Fortune 1000 list based on annual revenues for 2006[1]. By 2010, the company's sales revenues reached $2.8 billion, positioning it among the leading biopharmaceutical companies globally[1].

Key Products and Therapeutic Areas

Cephalon's product portfolio spanned several therapeutic areas:

1. Sleep Disorders: Provigil (modafinil) and Nuvigil
2. Pain Management: Actiq
3. Addiction Treatment
4. Cancer Therapies
5. Neurology: Gabitril for seizure disorders[1]

The company's "wake franchise," built on Provigil and later Nuvigil, became a significant revenue driver. Provigil sales alone approached one billion dollars in 2008[1].

Cephalon's Strengths and Competitive Advantages

Research and Development Capabilities

Cephalon's strength lay in its robust R&D capabilities. The company focused on:

1. Kinase inhibitors
2. Small molecule research
3. Biologic candidates (through acquisitions)[1]

Strategic Acquisitions

Cephalon's growth strategy included strategic acquisitions to expand its product portfolio and research capabilities:

1. CIMA Labs
2. Anesta
3. Laboratoire Lafon (which provided rights to modafinil)
4. Arana Therapeutics (2009)
5. Ception Therapeutics (2010)
6. ChemGenex Pharmaceuticals (2011)[1]

These acquisitions allowed Cephalon to diversify its portfolio and enter new therapeutic areas rapidly.

Global Presence

Cephalon established a strong global presence:

1. Headquarters in Frazer, Pennsylvania
2. Research operations in West Chester, Pennsylvania
3. Manufacturing in Minneapolis, Minnesota and Salt Lake City, Utah
4. European operations near Paris, France
5. R&D operations in Sydney, Australia (post-Arana acquisition)[1]

This global footprint enabled Cephalon to tap into diverse markets and talent pools.

Strategic Insights from Cephalon's Journey

Focus on Specialty Pharmaceuticals

Cephalon's success was largely built on its focus on specialty pharmaceuticals, particularly in neuroscience and oncology. This strategy allowed the company to target niche markets with high unmet needs and potentially higher profit margins.

Balancing Internal R&D with Strategic Acquisitions

Cephalon's approach balanced internal research efforts with strategic acquisitions. This dual strategy enabled the company to:

1. Maintain a strong pipeline of internally developed drugs
2. Quickly expand into new therapeutic areas through acquisitions
3. Acquire promising late-stage candidates to bolster near-term growth prospects

Leveraging Scientific Expertise

"Cephalon initially avoided involving itself in activities that would require maintaining a sales staff, managing clinical trials, and shepherding new drugs through the Food and Drug Administration (FDA) approval process. With no product to sell, Cephalon's only asset was its scientific expertise. That expertise proved sufficient to attract investors, and the company managed to fund its operations through research grants and contracts with larger pharmaceutical firms."[1]

This strategy allowed Cephalon to focus on its core strength - scientific innovation - while minimizing early-stage risks and capital requirements.

Challenges and Controversies

Despite its successes, Cephalon faced several challenges and controversies:

Legal Issues

1. In 1999, Cephalon settled a $17 million lawsuit over claims of overstating a drug's potential for treating ALS[1].
2. The Federal Trade Commission sued Cephalon for allegedly making illegal deals to delay generic competition to Provigil[1].
3. In 2008, Cephalon paid $425 million to settle whistleblower lawsuits and a criminal charge related to off-label marketing of Actiq, Gabitril, and Provigil[1].

These legal issues highlight the regulatory and ethical challenges pharmaceutical companies face, particularly regarding marketing practices and competition.

Patent Expirations and Generic Competition

Like many pharmaceutical companies, Cephalon faced challenges from patent expirations and generic competition. The company's efforts to protect its Provigil franchise through the development of Nuvigil and legal strategies demonstrate the ongoing struggle to maintain market share in the face of generic competition[3].

Cephalon's Acquisition by Teva: A Strategic Move

In 2011, Teva Pharmaceutical Industries acquired Cephalon for $6.8 billion[2]. This acquisition provided several strategic benefits:

1. Portfolio Diversification: The acquisition expanded Teva's branded portfolio, particularly in CNS, oncology, and pain management[2].
2. Pipeline Enhancement: Cephalon's pipeline added more than 30 compounds in late-stage development to Teva's portfolio[2].
3. Expanded Commercial and R&D Capabilities: Teva gained access to Cephalon's brand expertise, infrastructure, and talent in specialty pharma[2].
4. Synergies: The combination was expected to deliver significant synergies[2].

Impact on the Pharmaceutical Landscape

The Teva-Cephalon merger created a significant player in the pharmaceutical industry:

1. The combined company had pro forma branded sales of approximately $7 billion[2].
2. The merger positioned Teva-Cephalon as the fourth-largest pharma company by revenues and one of the most diversified[10].
3. The acquisition reinforced Teva's strategy of building out its branded and specialty pharmaceuticals business while maintaining its position as a leader in generics[9].

Lessons for Pharmaceutical Competitive Analysis

Cephalon's journey and eventual acquisition offer several key lessons for pharmaceutical competitive analysis:

1. Focus on Core Competencies: Cephalon's initial focus on scientific expertise allowed it to build a strong foundation.
2. Strategic Acquisitions: Well-timed acquisitions can rapidly expand capabilities and market presence.
3. Diversification: A diverse product portfolio can help mitigate risks associated with patent expirations and market changes.
4. Innovation Pipeline: Maintaining a strong pipeline of innovative products is crucial for long-term success.
5. Regulatory Compliance: Strict adherence to regulatory requirements is essential to avoid costly legal issues.
6. Market Positioning: Focusing on specialty pharmaceuticals can provide opportunities for higher margins and less competition.

Key Takeaways

1. Cephalon grew from a research-focused startup to a major player in specialty pharmaceuticals through strategic focus and acquisitions.
2. The company's success was built on a strong R&D foundation, particularly in neuroscience and oncology.
3. Cephalon faced challenges including legal issues and patent expirations, highlighting the importance of ethical practices and ongoing innovation.
4. The acquisition by Teva demonstrated the value of Cephalon's portfolio and pipeline in the competitive pharmaceutical landscape.
5. Cephalon's journey offers valuable insights for pharmaceutical competitive analysis, emphasizing the importance of strategic focus, diversification, and innovation.

FAQs

1. What were Cephalon's main therapeutic areas? Cephalon focused primarily on CNS disorders, oncology, pain management, and sleep disorders.

2. How did Cephalon grow from a startup to a major pharmaceutical company? Cephalon grew through a combination of internal R&D, strategic acquisitions, and a focus on specialty pharmaceuticals.

3. What was Cephalon's most successful product? Provigil (modafinil) was one of Cephalon's most successful products, with sales approaching $1 billion in 2008.

4. Why did Teva acquire Cephalon? Teva acquired Cephalon to diversify its branded portfolio, enhance its pipeline, and expand its capabilities in specialty pharmaceuticals.

5. What lessons can other pharmaceutical companies learn from Cephalon's journey? Key lessons include the importance of focusing on core competencies, strategic acquisitions, maintaining a strong innovation pipeline, and navigating regulatory challenges effectively.

Sources cited: [1] https://en.wikipedia.org/wiki/Cephalon [2] https://www.fiercepharma.com/pharma/teva-to-acquire-cephalon-6-8-billion-transaction [3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A62021TJ0074 [9] https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2011/Teva-Completes-Acquisition-of-Cephalon/default.aspx [10] https://www.drugchannels.net/2011/05/whats-behind-tevas-cephalon-deal.html