TIAMATE Drug Patent Profile

When do Tiamate patents expire, and what generic alternatives are available?

Tiamate is a drug marketed by Merck and is included in one NDA.

The generic ingredient in TIAMATE is diltiazem malate. There are twenty-six drug master file entries for this compound. Additional details are available on the diltiazem malate profile page.

Summary for TIAMATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	97
DailyMed Link:	TIAMATE at DailyMed

US Patents and Regulatory Information for TIAMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-001	Oct 4, 1996		DISCN	No	No
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-002	Oct 4, 1996		DISCN	No	No
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-003	Oct 4, 1996		DISCN	No	No

Expired US Patents for TIAMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-003	Oct 4, 1996	4,968,507
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-001	Oct 4, 1996	4,880,631
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-002	Oct 4, 1996	4,880,631
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-003	Oct 4, 1996	4,880,631
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-002	Oct 4, 1996	4,968,507
Merck	TIAMATE	diltiazem malate	TABLET, EXTENDED RELEASE;ORAL	020506-001	Oct 4, 1996	4,968,507

International Patents for TIAMATE

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

Country	Patent Number	Title	Estimated Expiration
Austria	73322
Australia	2277388
Australia	604564
Canada	1320885	POMPE OSMOTIQUE A POROSITE CONTROLEE (CONTROLLED POROSITY OSMOTIC PUMP)
Germany	3869032
Denmark	529188

Last updated: July 9, 2026

Tiamate (TIAMATE) Market Dynamics and Financial Trajectory: Current Commercial Status, Pricing Forces, and Patent-Driven Risk

TIAMATE’s market dynamics and financial trajectory depend on (1) whether TIAMATE is FDA-authorized under a specific listed active ingredient and dosage form, (2) its Orange Book and exclusivity profile, and (3) whether its commercialization is driven by branded sales, authorized generics, or biosimilar-like substitution mechanics (if applicable).

No TIAMATE drug product record, FDA marketing authorization, Orange Book listing, or public financial reporting link was provided in the input. Without a confirmed mapping of “TIAMATE” to an FDA-registered drug name (active ingredient, strength, dosage form, NDA/BLA/ANDA application, applicant/holder), a complete and accurate market-and-financial analysis cannot be produced.

What is TIAMATE and what is its FDA status (NDA, ANDA, BLA)?

Featured snippet answer: TIAMATE cannot be placed on an FDA approval and exclusivity timeline from the information provided.

Which active ingredient does TIAMATE correspond to?

Market dynamics, pricing, and exclusivity all hinge on the active ingredient and application type (NDA vs ANDA vs BLA). Without the mapped FDA identifier, the following cannot be stated accurately:

• Approval pathway (505(b)(1), 505(b)(2), 505(j))
• Therapeutic category (oncology, immunology, CNS, etc.)
• Label scope (indications drive TAM and payer behavior)

Is TIAMATE branded or an authorized generic?

Substitution mechanics differ sharply:

• Branded launch with exclusivity locks pricing early
• Authorized generic or approved generic competition compresses net price quickly
• Wholesale acquisition cost trends diverge from net revenue due to rebates

What patents protect TIAMATE and how do they affect future revenue?

Featured snippet answer: TIAMATE’s patent estate cannot be enumerated or expiration dates calculated without an Orange Book-linked product identity.

What is the Orange Book status of TIAMATE?

Key business inputs typically derived from the Orange Book:

• Drug substance and drug product patents
• Method-of-use patents
• Listed expiration dates
• Exclusivity codes tied to the approved product

When does TIAMATE lose exclusivity (patents and exclusivity)?

Financial trajectory is forecastable only when the first date of potential generic entry is known:

• Earliest paragraph IV window
• 180-day exclusivity triggers
• Pediatric exclusivity extensions (if applicable)

How many generic or biosimilar competitors can enter TIAMATE and when?

Featured snippet answer: Entry timing and number of challengers cannot be determined without confirming TIAMATE’s FDA listing and patent landscape.

What generic entry risks exist for TIAMATE?

Generic risk models require:

• Whether ANDAs have been filed
• Whether litigation under Hatch-Waxman is underway
• Settlement terms that determine “at-risk” launch or delayed entry

What is TIAMATE’s litigation and Paragraph IV history?

Financial impacts typically show up when:

• A first Paragraph IV filer wins or settles
• A design-around blocks approval or delays launch
• Final court decisions remove barriers

Without case identifiers and Orange Book patent numbers, no accurate launch risk window can be established.

How strong is the patent estate for TIAMATE (legal durability and design-around risk)?

Featured snippet answer: Patent strength cannot be scored without listed patents, claims scope, and relevant litigation posture.

What formulations are protected by TIAMATE patents?

Formulation patent coverage drives:

• Generic design-around complexity (different excipients, polymorphs, solid forms)
• Launch barriers for “same active, different product” entrants

What manufacturing methods are protected for TIAMATE?

Manufacturing-process patents can block approvals even when drug substance is off-patent.

What is the revenue trajectory for TIAMATE: launch ramp, net pricing, and share erosion?

Featured snippet answer: TIAMATE’s revenue and net price trajectory cannot be quantified without confirmed company disclosures, sales reporting entities, or benchmark datasets tied to the correct TIAMATE product.

How do payer dynamics and contracting typically affect TIAMATE net sales?

In the absence of TIAMATE’s indication and class:

• Coverage rules, formulary tiering, and rebate structure cannot be mapped
• Specialty distribution vs retail behavior cannot be inferred

What drives net price compression post-competition?

To forecast net revenue compression, analysts need:

• Generic entry dates
• Number of competitors at launch
• Post-entry rebate and tender patterns

None of this can be linked to TIAMATE from the provided content.

Which companies sell TIAMATE and how do their commercial strategies differ?

Featured snippet answer: Seller roster cannot be determined without a mapped NDA/BLA/ANDA application holder and labeled manufacturer.

What is the competitive landscape for TIAMATE?

Competitive landscape depends on:

• Direct therapeutic comparators within the same mechanism
• Substitutionability and switching friction
• Clinical guideline positioning

No indication-level mapping exists here.

How does TIAMATE compare with alternative therapies (class and mechanism) on market access and economics?

Featured snippet answer: Comparative economics cannot be assessed without TIAMATE’s indication, mechanism, and dosing.

Where does TIAMATE sit in treatment sequencing?

Sequencing determines:

• Patient volume capture
• Adherence and persistence
• Payer prior authorization intensity

What settlements or exclusivity-driven licensing deals affect TIAMATE commercialization?

Featured snippet answer: No licensing or settlement terms can be identified from the provided input.

What Paragraph IV settlements are relevant to TIAMATE?

Settlement agreements can dictate:

• “No-launch” periods
• Authorized generic dates
• Brand/generic profit-sharing structures

None can be listed without case records.

What regulatory events could change TIAMATE’s financial outlook (label changes, REMS, shortages)?

Featured snippet answer: Regulatory events cannot be tied to TIAMATE without FDA product identity and label history.

What is the Orange Book listing and does it change with amendments?

Amendments can:

• Add new patents and extend barriers
• Trigger new litigation windows
• Change the earliest generic entry date

Geographic coverage: where is TIAMATE marketed and how do export dynamics work?

Featured snippet answer: Geographic commercialization cannot be quantified without confirmed international approvals (e.g., EMA, MHRA) and local distribution arrangements.

What manufacturing/IP barriers exist for TIAMATE generics?

Featured snippet answer: Manufacturing and IP barriers cannot be assessed without identified patents and technical bottlenecks tied to the correct product.

Key Takeaways

• TIAMATE’s market dynamics and financial trajectory cannot be produced accurately without mapping “TIAMATE” to the correct FDA-authorized drug product and its Orange Book and exclusivity records.
• Patent-driven revenue outlook requires a confirmed TIAMATE identity to list patents, expiration dates, exclusivity windows, and Paragraph IV or litigation history.
• Revenue trajectory modeling requires confirmed product-level sales reporting and competitor entry timing.

FAQs

1. What is the Orange Book status of a TIAMATE product and how does it determine generic entry timing?
2. Which active ingredient and NDA/BLA correspond to “TIAMATE,” and what approvals govern its exclusivity?
3. How do Paragraph IV challenges and Hatch-Waxman settlements typically affect a TIAMATE launch timeline?
4. What formulation and method-of-use patents usually create design-around barriers for drugs like TIAMATE?
5. How does payer contracting and rebate structure change after generic entry for TIAMATE?

References

No sources were provided in the input, and no TIAMATE-specific FDA/Orange Book identifiers were supplied.