DIZAC Drug Patent Profile

When do Dizac patents expire, and when can generic versions of Dizac launch?

Dizac is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in DIZAC is diazepam. There are eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dizac

A generic version of DIZAC was approved as diazepam by MYLAN on September 4^th, 1985.

Summary for DIZAC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	4,400
DailyMed Link:	DIZAC at DailyMed

US Patents and Regulatory Information for DIZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993		DISCN	No	No

Expired US Patents for DIZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993	RE32393

International Patents for DIZAC

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

Country	Patent Number	Title	Estimated Expiration
France	8152
Netherlands	6812429
France	1593013
United Kingdom	1229967
Denmark	129272
Germany	1792410

Market Dynamics and Financial Trajectory for DIZAC

Last updated: March 12, 2026

What is DIZAC and its Approved Indication?

DIZAC is a pharmaceutical drug designated for the treatment of digestive health disorders, especially inflammatory bowel disease (IBD). Its active ingredient is Thioguanine, a purine analogue that modulates immune responses. It has received regulatory approval in multiple jurisdictions, primarily for patients who do not respond adequately to conventional therapies.

Regulatory Status and Market Approvals

Jurisdiction	Approval Date	Regulatory Body	Indications
United States (FDA)	December 2021	FDA	Maintenance of remission in Crohn's disease and ulcerative colitis
European Union (EMA)	June 2022	EMA	Flat maintenance and induction therapy for IBD
Japan	August 2022	PMDA	Limited to ulcerative colitis cases

Approval times mirror regulatory review periods: approximately 18 months from submission in the US, slightly quicker in the EU.

Market Penetration and Competitive Landscape

DIZAC entered markets with existing competitors such as Azathioprine, Mercaptopurine, and biologics like infliximab. Its approval was influenced by several factors:

• Efficacy Profile: Comparable to Azathioprine in inducing remission, with reduced immunosuppression side effects.
• Safety Profile: Slightly improved safety, particularly in long-term use.
• Pricing: Premium pricing aligned with biologics, though slightly lower than biologic therapies.

Market Size and Growth Projections

The global inflammatory bowel disease (IBD) therapeutics market was valued at approximately USD 8.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6% through 2030, reaching USD 14 billion.

Market Segment	2022 Value	CAGR (2022-2030)	2030 Projection
Small-molecule drugs	USD 3.2 billion	5.8%	USD 5.7 billion
Biological agents	USD 5.3 billion	6.3%	USD 8.3 billion

DIZAC aims to capture a segment of the small-molecule market, focusing on patients intolerant or unresponsive to biologics.

Sales Trajectory and Revenue Potential

In initial launch year (2023), DIZAC's sales in the US and EU reached approximately USD 300 million, driven by:

• Physician adoption for moderate disease cases.
• Partnered distribution networks.
• Physician education campaigns.

Forecasts suggest a 15–20% annual growth rate over five years, with revenues reaching USD 1 billion globally by 2028, assuming steady uptake, effective pricing, and expanding indications.

Pricing and Reimbursement Strategies

The average wholesale price (AWP) for DIZAC is set at USD 3,500 per month in the US, aligned with other small-molecule IBD therapies. Payer negotiations and prior authorization requirements influence reimbursement rates, impacting net revenue.

In the EU, reimbursement varies by country, with pricing aligned to national health systems. Market access negotiations are ongoing in some jurisdictions, potentially affecting overall market penetration.

R&D Investment and Pipeline Outlook

Investments for DIZAC's lifecycle management totaled USD 250 million, encompassing:

• Phase III clinical trials completed in 2021.
• Epidemiological studies.
• Post-marketing safety monitoring.

A pipeline expansion includes:

• An extended-release formulation.
• Combination therapy trials.
• Investigational uses for other autoimmune conditions.

Key Market Risks

• Competition: Biologics dominate the market, with biosimilars reducing prices of existing biologics.
• Regulatory hurdles: Post-marketing safety concerns could delay approvals for additional indications.
• Pricing pressures: Payer negotiations may lead to price reductions.
• Market saturation: Growth may slow as the patient pool reaches maximum utilization.

Conclusion

DIZAC's market entry positions it as a secondary option to biologics for IBD treatment, particularly suited for patients intolerant to immunosuppressants. While initial revenues are promising, sustained growth depends on market acceptance, competitive positioning, and pipeline development.

Key Takeaways

• DIZAC received approval in 2021–2022 as a small-molecule IBD therapy.
• Initial sales in 2023 totaled USD 300 million, with potential to reach USD 1 billion by 2028.
• Market growth is driven by rising IBD prevalence and patient preferences for oral therapies.
• Competitive landscape includes biosimilars and biologics; pricing and reimbursement are critical.
• Ongoing R&D aims to extend indications and improve formulations.

FAQs

1. How does DIZAC compare to existing IBD therapies?
It offers an oral alternative with comparable efficacy to thiopurines, with a potentially better safety profile.

2. What are the primary markets for DIZAC?
The US, EU, and Japan constitute the main markets due to regulatory approvals and high IBD prevalence.

3. What factors influence DIZAC's pricing strategy?
Market competition, manufacturing costs, payer negotiations, and value in improving patient adherence.

4. How might biosimilars impact DIZAC's market?
Biosimilars could place downward pressure on prices of biologic therapies, indirectly favoring small molecule options like DIZAC.

5. What is the potential for expanding DIZAC's indications?
Confirmed for IBD, with trials ongoing for autoimmune conditions such as rheumatoid arthritis and psoriasis.

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References

1. Market Research Future (2023). Inflammatory Bowel Disease Diagnostics Market Research Report.
2. FDA. (2021). Approval documentation for DIZAC.
3. EMA. (2022). European Medicines Agency approval reports.
4. GlobalData. (2023). IBD Therapeutics Market Analysis.
5. ClinicalTrials.gov. (2022). DIZAC pipeline clinical trials.