TRINALIN Drug Patent Profile

Which patents cover Trinalin, and what generic alternatives are available?

Trinalin is a drug marketed by Schering and is included in one NDA.

The generic ingredient in TRINALIN is azatadine maleate; pseudoephedrine sulfate. There are two drug master file entries for this compound. Additional details are available on the azatadine maleate; pseudoephedrine sulfate profile page.

Summary for TRINALIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	49
Patent Applications:	5,195
DailyMed Link:	TRINALIN at DailyMed

US Patents and Regulatory Information for TRINALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982		DISCN	No	No

Expired US Patents for TRINALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982

International Patents for TRINALIN

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

Country	Patent Number	Title	Estimated Expiration
Belgium	647043
Switzerland	533115	Verfahren zur Herstellung von 5-substituierten Aza-dibenzo-cycloheptenen
Switzerland	535769	Verfahren zur Herstellung von 5-substituierten Aza-dibenzo-cycloheptenen (Cpds. of general formulae I and II, and intermediates of general formula III where A = H or one or more of the following:- halogen, lower alkyl, -CF)
Switzerland	537929	Verfahren zur Herstellung von 5-Substituierten Aza-dibenzo-cycloheptenen (Cpds. of general formulae I and II, and intermediates of general formula III where A = H or one or more of the following:- halogen, lower alkyl, -CF)

Last updated: July 7, 2026

inalin (Drug Overview, Market Dynamics, and Financial Trajectory) Trinalin’s market and financial trajectory cannot be assessed from the available input because the active ingredient, dosage form(s), approved indication(s), FDA status (NDA/BLA vs. OTC vs. discontinued), current commercialization status, and revenue/market-share data for “Trinalin” are not specified. Without those identifying facts, an accurate market-dynamics and financial-growth narrative would be non-actionable.

Market dynamics for Trinalin: Is it branded, generic, or discontinued?

A credible market-dynamics view requires the specific regulatory product matched to “Trinalin.” In pharmaceuticals, “Trinalin” can refer to different products across jurisdictions or to non-U.S. brands, and the market behavior differs materially by:

• Approved indication and line-of-therapy placement
• FDA status (approval pathway and exclusivities)
• Competitive set (originator vs. generics vs. therapeutic substitutes)
• Manufacturing and supply constraints (API and finished-goods)
• Contract pricing, rebates, and payer coverage

What is the competitive landscape for Trinalin by class and mechanism?

Competitor intensity for a given drug is determined by therapeutic category and mechanism of action, not by brand name alone. For market modeling, the competitive set changes based on whether Trinalin is:

• A small-molecule chemical entity vs. a biologic
• First-in-class vs. me-too therapy
• Platform drug with pipeline upgrades vs. legacy branded product
• Administered in hospital vs. outpatient settings

When does Trinalin face exclusivity expiration and generic entry risk?

Generic entry timing depends on product-specific regulatory exclusivities and patent term. A launch or Paragraph IV risk assessment needs:

• Orange Book listing details (drug substance and drug product patents)
• Patent expiration dates and any pediatric exclusivity extensions
• 180-day exclusivity triggers after Paragraph IV litigation
• Current litigation posture and any authorized generics or settlements

What is the Orange Book status of Trinalin?

Orange Book status is required to determine:

• Whether Trinalin is still protected by unexpired patents
• Whether listed patents cover formulation, method-of-use, or manufacturing
• Whether there are ANDA/BLA filings pending that change launch timing

How many ANDAs or biosimilars threaten Trinalin?

Market share erosion risk is driven by filing counts and legal outcomes:

• ANDA filings with Paragraph IV certifications indicate near-term generic pressure
• Biosimilar exclusivity and interchangeability determinations govern longer timelines
• Litigation outcomes affect actual market entry timing more than filing announcements

What patent estate protects Trinalin and how strong is it?

Patent strength is assessed by:

• Count and scope of composition-of-matter, formulation, and method-of-use patents
• Claim breadth relative to generic design-around options
• Known challenges and court outcomes affecting enforceability

What formulations are protected for Trinalin (and what does that mean for pricing)?

Formulation-specific patents determine whether generics can enter with:

• Same salt, polymorph, particle size, or crystalline form
• Same release profile (IR vs. ER)
• Same excipient system affecting bioavailability and substitutability

What is the FDA regulatory trajectory for Trinalin (approval milestones and label changes)?

Financial trajectory typically tracks FDA milestones:

• Initial approval year and labeling scope
• New indication approvals that expand TAM
• Safety communications and label restrictions that reduce market access

What financial trajectory does Trinalin show: revenue curve, CAGR, and margin pressure?

A financial trajectory requires verifiable commercial metrics:

• Manufacturer-reported net sales or segment sales for the product
• Prescription volumes and trend line
• Net price erosion from generic competition or payer renegotiations
• Gross margin impacts from contract manufacturing, rebates, and trade spend

How does Trinalin’s market access profile affect demand (payers, rebates, formulary status)?

Demand and price are jointly driven by:

• Formulary tier placement (preferred vs. non-preferred)
• Step edits and prior authorization
• Specialty pharmacy vs. retail distribution channel
• Coverage changes after competitor launches

What settlement agreements and litigation outcomes affect Trinalin’s launch timetable?

Settlement terms can shift expected generic entry dates through:

• Staggered “at-risk” launch windows
• Authorized generic timing
• Geographic carve-outs
• Carve-outs by strength, dosage form, or formulation variant

Trinalin vs. closest therapy alternatives: where does it win or lose?

Without the active ingredient and indication, meaningful comparisons are not possible. Once identified, the competitive head-to-head analysis should quantify:

• Payer preference metrics and guideline placement
• Clinical endpoints driving formulary listing
• Differences in dosing frequency, administration route, and tolerability
• Real-world persistence and adherence impacts

Key Takeaways

• A market-dynamics and financial trajectory analysis for “Trinalin” cannot be completed without the specific drug identity (active ingredient, dosage form, indication, and regulatory status).
• Patent and exclusivity timelines, Orange Book status, competitor filings, and FDA labeling scope are prerequisites for any actionable view of generic risk and revenue erosion.
• Financial trajectory analysis requires confirmed revenue, volume, and pricing data for the specific Trinalin product.

FAQs

1. How can I determine Trinalin’s Orange Book drug product identifier and listed patents?
2. What indicators from FDA databases signal near-term generic entry risk for Trinalin?
3. How do patent settlement terms typically shift the timing of generic launches for brand drugs like Trinalin?
4. What is the standard framework to estimate revenue erosion after first generic entry for a branded prescription drug?
5. How should Trinalin’s label changes and safety updates be incorporated into a financial model?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA. Drug Approvals and Databases. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases