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:	70
Patent Applications:	3,978
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	019369-002	Sep 30, 1986
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	019369-001	Sep 30, 1986

International Patents for TEGISON

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

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

TEGISON market dynamics and financial trajectory (2026 outlook): pricing pressure, uptake drivers, exclusivity and competitive risks

Last updated: June 16, 2026

What is TEGISON and how does it make money?

TEGISON is a branded pharmaceutical drug marketed for [missing active ingredient/indication]. Without the active ingredient, strength, dosage form, target indication, and geography, market sizing, reimbursement analysis, and revenue trajectory cannot be accurately mapped to a specific product profile.

What are the key market dynamics shaping TEGISON demand?

A product’s demand and revenue path in pharmaceuticals is typically driven by: formulary status, payer coverage, clinical differentiation versus standard of care, channel inventory, and competitive entry timing. For TEGISON, those drivers require an anchored product definition (active ingredient, dose form, and approved use).

Which payer and reimbursement forces matter most?

• Formulary placement (preferred vs non-preferred)
• Prior authorization requirements
• Step therapy and utilization management
• Wholesale acquisition cost to net price discount rate

What drives physician adoption and persistence?

• Clinical guideline alignment for the labeled indication
• Safety and tolerability profile
• Availability of patient support programs
• Dosing convenience and adherence (frequency, route, administration time)

How do supply and manufacturing constraints affect revenue?

• Allocation risk during ramp-up
• Batch release delays
• Raw material or API supply dependency
• Contract manufacturing capacity

When does TEGISON lose exclusivity and what does that mean for revenue?

Revenue cliffs in branded pharmaceuticals usually come from:

• Patent expirations (composition, method-of-use, formulation)
• Regulatory exclusivities (where applicable)
• Generic or biosimilar entry following ANDA/505(b)(2) or 351(k) pathways
• Settlement-driven “carve-out” dates

For TEGISON, the exclusivity timeline cannot be produced without product-anchoring details (FDA/NDA or international authorization reference, Orange Book or equivalent listings, and patent numbers).

What patents protect TEGISON and how strong is the patent estate?

Patent strength is determined by:

• Coverage breadth (composition vs formulation vs use)
• Remaining term by jurisdiction
• Litigation history and court outcomes
• Barrier to design-around (hard-to-evade formulation or method-of-use claims)

A defensible patent-coverage map for TEGISON requires specific patent datasets keyed to the drug’s regulatory reference product.

Is TEGISON at risk of generic entry? What Paragraph IV challenges matter?

Paragraph IV challenges generally forecast:

• Near-term price erosion once first generics launch
• Potential “at-risk” launch incentives
• Settlement ranges and launch delay outcomes

TEGISON’s generic-risk profile cannot be quantified without knowing its regulatory pathway and whether it is listed in the US FDA Orange Book (or analogous registries).

What is the Orange Book status of TEGISON?

Orange Book status is typically the starting point for exclusivity modeling:

• Listed patents by NDA/BLA
• Expiration dates per listed patent
• Exclusivity start/end dates
• Dosage form and route specificity

Orange Book status for TEGISON cannot be stated without an NDA/BLA identifier.

How does TEGISON compare with competing brands and generics on price and uptake?

A competitive landscape view requires:

• Active ingredient equivalence (same MoA or same indication class)
• Therapeutic alternatives (same line of therapy)
• Benchmark pricing versus class leaders
• Market share and segment penetration

Without TEGISON’s active ingredient and indication, no reliable comparison can be made.

What do revenue metrics typically look like for drugs like TEGISON, and where would the inflection points be?

For branded small-molecule products, a common revenue trajectory is:

• Launch ramp (2–3 years)
• Peak sales during exclusivity and formulary consolidation
• Decline after patent expiry or settlement-triggered generic entry
• Possible plateau if additional indications or line extensions exist

For TEGISON, revenue metrics and inflection points cannot be computed without at least: approved indication, geography, payer environment, and sales reporting source.

What litigation or settlements could affect TEGISON’s commercial timeline?

Patent litigation can reshape launch timing via:

• Temporary restraining orders or preliminary injunctions
• Final infringement findings
• Carve-out settlements that delay or restrict launch
• Design-around outcomes that change the scope of competition

A litigation timeline for TEGISON requires case identifiers and regulatory reference.

What FDA pathway and regulatory milestones govern TEGISON commercialization?

Commercial timing depends on:

• Approval date and initial labeling scope
• Pediatric exclusivity or other statutory exclusivities (if applicable)
• Postmarketing commitments and label updates
• Manufacturing change approvals affecting supply stability

A regulatory milestones timeline cannot be produced without the relevant approval record.

What manufacturing and IP barriers could delay generic competition?

Generic entry is typically delayed by:

• Formulation or manufacturing process patents (equipment, particle size, polymorphs)
• Method-of-use patents tied to clinical dosing regimens
• Data exclusivity constraints under 505(b)(2)
• Regulatory constraints tied to bioequivalence approaches

TEGISON-specific barriers cannot be assessed without patent and formulation disclosures.

How big is the TEGISON market exposure and what is the financial trajectory under generic scenarios?

A scenario model usually includes:

• Date of first potential generic entry
• Expected market share capture by generics within 6–24 months
• Net price erosion (WAU-to-net and reimbursement changes)
• Volume offsets from expansion or new patients

No scenario can be grounded for TEGISON without market definition and exclusivity entry dates.

Key takeaways

• TEGISON’s market dynamics and financial trajectory cannot be accurately quantified without product anchoring details (active ingredient, indication, dosage form, and regulatory reference).
• Revenue risk, exclusivity timing, generic entry likelihood, and patent estate strength must be computed from Orange Book (or local equivalents) and linked patent datasets.
• A defensible commercial scenario requires confirmed: patent expiration and exclusivity dates, litigation/settlement records, and competitor mapping by MoA and reimbursement class.

FAQs

1. What data source is required to map TEGISON’s exclusivity and generic-entry dates accurately?
2. How do net price and formulary placement typically drive revenue trajectories for branded pharmaceuticals like TEGISON?
3. What patent categories most often block generics for branded oral drugs (composition, formulation, or method-of-use)?
4. How do settlement agreements between brand and generic companies shift launch timing and revenue cliffs?
5. Which FDA listings (Orange Book, label history, regulatory exclusivities) should be used to forecast TEGISON’s downside?

References

No sources cited.