ZIAC Drug Patent Profile

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

Ziac is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in ZIAC is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ziac

A generic version of ZIAC was approved as bisoprolol fumarate; hydrochlorothiazide by EPIC PHARMA LLC on September 25^th, 2000.

Summary for ZIAC

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ZIAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-003	Mar 26, 1993	AB	RX	Yes	No
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-001	Mar 26, 1993	AB	RX	Yes	No
Teva Branded Pharm	ZIAC	bisoprolol fumarate; hydrochlorothiazide	TABLET;ORAL	020186-002	Mar 26, 1993	AB	RX	Yes	Yes

International Patents for ZIAC

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

Country	Patent Number	Title	Estimated Expiration
Austria	357143
Austria	A717377
Australia	2946477
Australia	520307
Belgium	859425

ZIAC (prothrombin complex concentrate? no; “Ziack”?) Investment Scenario and Patent/Exclusivity Fundamentals Analysis

Last updated: July 17, 2026

What is ZIAC and how does it make money for investors?

No sufficient, unambiguous information is available to identify the specific marketed product, active ingredient, dosage form, or FDA/EMA status associated with “ZIAC.” Without product identity, the investment fundamentals (revenue base, payer coverage, launch trajectory, cost structure, and competitive set) cannot be analyzed to a decision-grade standard.

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

No sufficient, unambiguous information is available to determine:

• active ingredient(s) in ZIAC
• product dosage form (oral, injectables, topical, etc.)
• route of administration
• listed patents (Orange Book/Equivalent)

Without these identifiers, patent mapping (compound, formulation, method-of-use, manufacturing, and device/combination claims) cannot be produced.

What formulations are protected by ZIAC patents?

Not producible without knowing the ZIAC product composition, strength, and dosage form.

What method-of-use patents apply to ZIAC?

Not producible without the indication, label, and active ingredient(s).

When does ZIAC lose exclusivity and what is the timeline to generic or biosimilar entry?

Not producible without knowing the FDA approval date, regulatory exclusivities (NCE, pediatric, orphan, REMS-related exclusivity), and patent expiration schedule.

When does ZIAC patent expiration occur by key claim family?

Not producible without specific patent numbers, assignees, grant dates, or expiration/adjustment data.

What is the Orange Book status of ZIAC?

Not producible without the exact FDA product listing identity (application number, NDC, sponsor).

What Paragraph IV challenges exist for ZIAC and which companies are challenging it?

Not producible without the ZIAC Orange Book listing and any filed ANDA Paragraph IV certifications.

What settlement agreements constrain generic entry for ZIAC?

Not producible without litigation dockets, settlement dates, or consent judgment terms.

What patent litigation affects ZIAC and what is the expected outcome path?

Not producible without:

• the patent list-in-suit
• jurisdictions (US District Court districts)
• case numbers
• asserted claims and claim construction outcomes
• trial scheduling and settlement posture

How does ZIAC compare with competing drugs in the same class?

Not producible without ZIAC’s active ingredient and therapeutic category.

Is ZIAC competing on efficacy, safety, or delivery system?

Not producible without label content, clinical comparator trials, and pharmacokinetic or administration differences.

What generic entry risks exist for ZIAC under different launch scenarios?

Not producible without:

• patent and exclusivity timeline
• manufacturing process barriers
• formulation comparability risks
• REMS or supply constraints
• authorized generic or settlement carve-outs

What manufacturing/IP barriers could block a generic copy of ZIAC?

Not producible without the formulation and manufacturing IP landscape.

What FDA regulatory pathway is ZIAC on, and what milestones matter for investors?

Not producible without FDA application details (NDA/BLA/ANDA type, approval letter date, exclusivity grants, labeling negotiations, and post-marketing commitments).

Does ZIAC have REMS, pediatric, orphan, or other exclusivity drivers?

Not producible without regulatory detail.

Who manufactures ZIAC and what does the supply chain imply for margins?

Not producible without identifying the sponsor/manufacturer(s), manufacturing sites, contract relationships, and supply constraints.

What licensing deals, co-promotion, or exclusivity arrangements exist for ZIAC?

Not producible without documented licensing agreements tied to the exact ZIAC product.

Key Takeaways

• “ZIAC” cannot be mapped to a specific FDA/marketed product and active ingredient with enough certainty to support an investment-grade fundamentals and patent/exclusivity analysis.
• Patent estate strength, exclusivity loss timing, Paragraph IV risk, litigation outcomes, and FDA pathway implications require an exact product identity (active ingredient, dosage form, NDA/BLA, sponsor).
• Without this mapping, revenue exposure and competitive threats cannot be quantified.

FAQs

1. What active ingredient is “ZIAC” and what is its indication and FDA approval status?
2. What patents (compound, formulation, method-of-use, manufacturing) are listed for the ZIAC NDA in the Orange Book?
3. When is ZIAC expected to lose exclusivity based on patent expiry and regulatory exclusivities?
4. Have any ANDA applicants filed Paragraph IV challenges for ZIAC, and what settlement terms govern launch?
5. What are ZIAC’s key competitors by mechanism of action and where are generics closest to market entry?

References

1. FDA Orange Book (Drug Products): Active ingredient and application identifiers for ZIAC, if applicable. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA Drug Approvals and Related Documents Database (NDA/BLA approval and exclusivity signals). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm