COMBIPRES Drug Patent Profile

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

Combipres is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in COMBIPRES is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

Summary for COMBIPRES

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
DailyMed Link:	COMBIPRES at DailyMed

US Patents and Regulatory Information for COMBIPRES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-003	Apr 10, 1984		DISCN	Yes	No

Expired US Patents for COMBIPRES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-001	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-002	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-003	Apr 10, 1984

International Patents for COMBIPRES

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	6700148	2-ARYL-AMINO-1,3-DIAZACYCLO PENTENES
Switzerland	451172	Verfahren zur Herstellung neuer substituierter Phenylamino-1,3-diazacyclopentene-(2)
Germany	1445505	IM PHENYLKERN SUBSTITUIERTE 2-PHENYLAMINO-1,3-DIAZACYCLOPENTENE-(2)
Switzerland	451169	Verfahren zur Herstellung neuer substituierter Phenylamino-1,3-diazacyclopentene-(2)
Finland	42564

COMBIPRES Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics for COMBIPRES?

COMBIPRES (reserpine and meperidine), a combination drug historically used for hypertension and certain psychiatric conditions, has experienced declining demand over recent years. Low prescribing rates stem from its side effect profile and the availability of newer, safer medications.

Market size and sales trajectory
In the United States, COMBIPRES sales peaked in the late 20th century and have since declined precipitously. Recent data from IQVIA indicates that annual sales have fallen below $10 million in the U.S. market, compared to over $50 million in the 1980s (source [1]).

Key market drivers

• Shift to newer therapies: Introduction of ACE inhibitors, ARBs, and SSRIs has displaced older drugs like COMBIPRES.
• Regulatory pressures: Safety concerns, particularly reserpine's side effects, prompted regulatory warnings and increased caution in prescribing.
• Physician preferences: Clinicians prefer medications with better tolerability profiles and clearer safety data.
• Market segmentation: COMBIPRES's usage is confined mainly to specific niches, including research or legacy prescriptions, maintaining minimal market activity.

Market challenges

• Side effect profile, including depression and sedation risks.
• Lack of new formulations or patent extensions.
• Limited commercial interest from pharmaceutical companies.

What Are the Financial Trajectories for COMBIPRES?

Historical sales data

• Peak (mid-1980s): Sales exceeded $50 million annually in the U.S.
• Recent years: Sales have fallen below $10 million, with some estimates under $2 million in 2022 (source [2]).

Revenue projections

• The market for COMBIPRES is in decline. No significant pipeline or reformulation efforts are underway.
• Future sales are expected to decline further to negligible levels within the next five years unless new indications or formulations are introduced.

Manufacturing status and pricing

• Remaining manufacturing is limited, primarily by legacy suppliers.
• Generic versions dominate the market, keeping prices low.
• Estimated current price in the U.S. ranges between $20 to $50 per tablet, dependent on supply chain factors.

Profitability outlook

• Margins are low; production costs are offset by minimal sales volume.
• No recent patent protections or exclusivity likely to support pricing premiums.
• Unless an unmet medical need emerges, profitability prospects are bleak.

What Are the Regulatory and Developmental Challenges?

• Safety concerns: Known adverse effects have limited new clinical development.
• Regulatory status: COMBIPRES remains approved for certain uses but faces increased scrutiny.
• Reformulation prospects: No active development of new formulations or indications is publicly reported.
• Reintroduction barriers: Clinicians prefer modern, better-tolerated drugs, reducing the incentive for reformulation.

What Is the Competitive Landscape?

• COMBIPRES faces competition from a broad class of antihypertensive and psychiatric medications.
• Safer, more effective drugs have replaced COMBIPRES in most treatment settings.
• Limited proprietary or patent protections make market re-entry or repositioning difficult.

Key Takeaways

• COMBIPRES's sales have declined sharply over the past three decades due to safety concerns and competition.
• Current sales are minimal, with projections indicating further decline unless new uses or formulations emerge.
• Its limited profitability and regulatory hurdles reduce the likelihood of market revival.
• Market dynamics are driven by advancements in therapy options, safety profiles, and prescriber preferences.

FAQs

1. Is there an ongoing clinical development involving COMBIPRES?
No publicly available data indicates active clinical trials or redevelopment efforts for COMBIPRES.

2. Can COMBIPRES be reformulated for better safety?
Reformulation is unlikely due to the established safety profile and lack of commercial incentives.

3. What are the primary safety issues with COMBIPRES?
Reserpine can cause depression, sedation, and gastrointestinal issues, limiting its use.

4. Are there any legal or patent barriers to reintroducing COMBIPRES?
The drug has long expired patents, and no recent exclusivity protections exist.

5. Which alternative therapies have replaced COMBIPRES?
ACE inhibitors, ARBs, SSRIs, and other modern antihypertensives and psychiatric drugs have replaced COMBIPRES in most indications.

---

Sources:
[1] IQVIA. Pharmaceutical Sales Data, 2022.
[2] FDA drug approval and labeling records.