TEGISON Drug Patent Profile

Which patents cover Tegison, and when can generic versions of Tegison launch?

Tegison is a drug marketed by Roche and is included in one NDA.

The generic ingredient in TEGISON is etretinate. Additional details are available on the etretinate profile page.

Summary for TEGISON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	3,444
DailyMed Link:	TEGISON at DailyMed

US Patents and Regulatory Information for TEGISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-001	Sep 30, 1986		DISCN	No	No
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-002	Sep 30, 1986		DISCN	No	No

Expired US Patents for TEGISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-001	Sep 30, 1986
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-002	Sep 30, 1986
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-002	Sep 30, 1986
Roche	TEGISON	etretinate	CAPSULE;ORAL	019369-001	Sep 30, 1986

International Patents for TEGISON

See the table below for patents covering TEGISON around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	60406
Germany	2862480
European Patent Office	0002533	USE OF RETINOIDS AS MEDICINES

TEGISON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tegison (Etretinate)

Introduction

Tegison, known chemically as etretinate, is a second-generation retinoid developed by Hoffmann–La Roche for the treatment of severe psoriasis. Approved by the FDA in 1986, the drug had a significant impact on the market for psoriasis treatments, but its trajectory was marked by both success and significant challenges.

Approval and Initial Market Impact

Etretinate was approved by the FDA in 1986, offering a new treatment option for patients with severe psoriasis. Initially, it was well-received due to its efficacy in treating this chronic and often debilitating condition. The drug's mechanism of action, which involves interfering with the terminal differentiation of keratinocytes and activating retinoid receptors, made it a valuable addition to the therapeutic arsenal against psoriasis[1][4].

Market Presence and Distribution

Tegison was marketed in several countries, including the United States, Canada, and Japan. However, its market presence was not uniform across these regions. In Japan, it remains available under the brand name Tigason, while in the United States and Canada, it was eventually withdrawn due to safety concerns[1][4].

Safety Concerns and Market Withdrawal

One of the most significant factors affecting the market dynamics of Tegison was its high risk of causing birth defects. Etretinate is a teratogen, meaning it can cause severe birth defects even after treatment has stopped. This led to stringent precautions, including the requirement for birth control during and for at least three years after therapy. Despite these measures, the risk was deemed too high, and the drug was removed from the Canadian market in 1996 and the U.S. market in 1998[1][4].

Financial Implications of Safety Concerns

The withdrawal of Tegison from major markets had significant financial implications for Hoffmann–La Roche. The drug's revenue declined sharply as it was no longer available for prescription in the U.S. and Canada. Additionally, the company faced potential legal and regulatory challenges related to the drug's safety profile, further impacting its financial trajectory.

Replacement by Acitretin

Following the withdrawal of Tegison, its successor, acitretin, was introduced. Acitretin is the free acid form of etretinate and has a shorter half-life and lower lipophilicity, making it less risky in terms of long-term side effects. However, acitretin is still a long-acting teratogen and requires similar precautions regarding pregnancy. The transition to acitretin helped mitigate some of the financial losses but did not fully restore the market presence of Tegison[1].

Impact on Generic Drug Market

The generic drug market dynamics, as studied by the Federal Trade Commission, suggest that the entry of generic competitors can significantly reduce prices and alter market dynamics. However, in the case of Tegison, its removal from the market precluded the development of generic versions, as there was no longer a viable market for such products[3].

Side Effects and Patient Impact

The side effects of Tegison, typical of hypervitaminosis A, included bone or joint pain, muscular or abdominal cramps, and dry, burning, itching eyelids. These side effects, while manageable, contributed to the drug's negative perception and further impacted its market viability[1].

Regulatory and Legal Considerations

The regulatory environment played a crucial role in the market dynamics of Tegison. The FDA's decision to approve the drug was followed by strict monitoring and eventual withdrawal due to safety concerns. This regulatory scrutiny not only affected the drug's availability but also influenced public and medical community perceptions, leading to a decline in its use even before its official withdrawal[1].

Blood Donation Restrictions

An additional financial and social impact was the restriction on blood donation for individuals who had taken Tegison. In several countries, including the U.S., U.K., Australia, Ireland, and Québec, individuals who had ever taken etretinate were not eligible to donate blood, further highlighting the drug's long-lasting effects and contributing to its negative market image[1].

Key Takeaways

• Approval and Initial Success: Tegison was approved in 1986 and initially well-received for treating severe psoriasis.
• Safety Concerns: High risk of birth defects led to its withdrawal from the U.S. and Canadian markets.
• Financial Implications: Significant decline in revenue due to market withdrawal and legal/regulatory challenges.
• Replacement by Acitretin: Transition to a safer alternative, but with similar precautions.
• Impact on Generic Market: No generic versions developed due to the drug's removal from the market.
• Side Effects and Patient Impact: Manageable but significant side effects contributed to negative perceptions.
• Regulatory and Legal Considerations: Strict FDA monitoring and eventual withdrawal due to safety concerns.

FAQs

What was Tegison used for?

Tegison (etretinate) was used to treat severe psoriasis.

Why was Tegison withdrawn from the market?

Tegison was withdrawn from the U.S. and Canadian markets due to its high risk of causing birth defects.

What are the side effects of Tegison?

Common side effects include bone or joint pain, muscular or abdominal cramps, and dry, burning, itching eyelids.

Is Tegison still available in any markets?

Yes, Tegison remains available in Japan under the brand name Tigason.

What replaced Tegison in the market?

Acitretin, the free acid form of etretinate, replaced Tegison as a safer alternative.

Sources

1. Wikipedia: Etretinate
2. FDA: 215559Orig1s000 Integrated Review
3. Federal Trade Commission: Generic Drug Industry Dynamics
4. Inxight Drugs: ETRETINATE
5. FDA: 125521Orig1s000 Clinical Outcome Assessment Review