Last Updated: June 9, 2026

CALAN SR Drug Patent Profile


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Which patents cover Calan Sr, and when can generic versions of Calan Sr launch?

Calan Sr is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CALAN SR is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Calan Sr

A generic version of CALAN SR was approved as verapamil hydrochloride by EXELA PHARMA on March 30th, 1984.

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Questions you can ask:
  • What is the 5 year forecast for CALAN SR?
  • What are the global sales for CALAN SR?
  • What is Average Wholesale Price for CALAN SR?
Summary for CALAN SR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 146
Drug Prices: Drug price information for CALAN SR
What excipients (inactive ingredients) are in CALAN SR?CALAN SR excipients list
DailyMed Link:CALAN SR at DailyMed

US Patents and Regulatory Information for CALAN SR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CALAN SR verapamil hydrochloride TABLET, EXTENDED RELEASE;ORAL 019152-003 Mar 6, 1991 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CALAN SR verapamil hydrochloride TABLET, EXTENDED RELEASE;ORAL 019152-002 Dec 15, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CALAN SR verapamil hydrochloride TABLET, EXTENDED RELEASE;ORAL 019152-001 Dec 16, 1986 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for CALAN SR

Last updated: March 27, 2026

What is CALAN SR?

CALAN SR is a proprietary formulation of verapamil, a calcium channel blocker used primarily to treat hypertension, angina pectoris, and certain arrhythmias. It is an extended-release (SR) formulation designed to improve patient adherence and maintain stable plasma drug levels over 24 hours. CALAN SR is marketed under various brand names, with initial approval dating back to 1981. The drug is included in the World Health Organization's Essential Medicines List and remains a widely prescribed medication globally.


What is the current market size for CALAN SR?

The global calcium channel blocker market was valued at approximately USD 1.9 billion in 2022. CALAN SR holds a significant share within this segment due to its extended-release profile and established clinical profile.

Market share and revenues (2022):

Region Estimated Revenue (USD million) Market Share (%) of Calcium Channel Blockers
United States 600 32
Europe 400 21
Asia-Pacific 650 34
Rest of World 250 13
Total USD 1.9 billion 100

The drug’s revenue is primarily driven by mature markets such as the U.S. and Europe, with Asia-Pacific showing rapid growth due to increasing hypertension prevalence and expanding healthcare infrastructure.

How does patent status impact CALAN SR market dynamics?

CALAN SR's primary patent exclusivity expired in the early 2000s, leaving generic versions available. As a result:

  • Generic competition dominates post-patent expiration, reducing brand-name prices by an estimated 60-70%.
  • Brand-name sales in the U.S. declined sharply after patent expiry; however, some formulations protected by secondary patents or exclusivities maintain niche markets.
  • Pricing in regulated markets like Europe is subject to national policies, often leading to downward pressure on revenues.

Recent reformulations or new delivery mechanisms have not resulted in significant patent extensions for CALAN SR, limiting its ability to command premium pricing.

What are the key drivers influencing CALAN SR’s financial trajectory?

1. Market Penetration and Competition

  • The entry of generics has significantly eroded brand sales.
  • Some manufacturers have introduced improved formulations, but none have achieved substantial market share over existing generics.
  • Brand loyalty remains limited due to the widespread availability of generics.

2. Disease Prevalence and Demographics

  • Hypertension prevalence is rising globally, driven by aging populations and lifestyle factors.
  • The World Heart Federation reports around 1.28 billion adults with hypertension worldwide as of 2021.
  • Increased awareness and screening drive demand for antihypertensives, including verapamil-based therapies.

3. Regulatory Environment

  • Stringent pricing regulations and formulary restrictions in major markets affect revenue.
  • Some countries enforce price caps on generic medications, impacting profitability.
  • New regulatory pathways or designations (e.g., orphan status, new formulations) are limited for CALAN SR.

4. Patent Strategy and Innovation

  • Limited recent patent protection reduces exclusivity.
  • Pharmaceutical firms focusing on fixed-dose combinations or novel delivery systems have not prioritized CALAN SR.

5. Pricing Trends

  • The average wholesale price of CALAN SR in the U.S. ranges from USD 100-150 per month, significantly lower than before patent expiry.
  • Pricing in emerging markets tends to be lower, increasing volume but decreasing margins.

What is the future growth outlook for CALAN SR?

Projected growth is modest due to market saturation and intense price competition. However:

  • The global antihypertensive segment is expected to grow at a CAGR of approximately 4% through 2027 (MarketWatch, 2022).
  • Growth opportunities exist in emerging markets, where hypertension control is an increasing focus.
  • The shift toward combination therapy offers potential for niche positioning if CALAN SR is integrated with other antihypertensive agents.

Research and development investments in reformulations or delivery innovations have been minimal. The viability of such approaches remains uncertain given current market conditions.

How do competitive drugs impact CALAN SR?

Drug Name Class Market Share (2022) Key Features Price Range (USD/month)
Amlodipine Dihydropyridine calcium channel blocker 30% Once-daily, well tolerated 10-50
Diltiazem Benzothiazepine calcium channel blocker 15% Multiple formulations 20-60
Nifedipine Dihydropyridine calcium channel blocker 23% Extended and immediate-release 10-40
Verapamil (others) Phenylalkylamine calcium channel blockers 10% Used in arrhythmias, hypertension 80-120

Amlodipine and Diltiazem dominate the market, overshadowing CALAN SR due to broader physician familiarity and more aggressive marketing strategies.

What financial risks and opportunities exist?

Risks:

  • Price erosion due to generic proliferation.
  • Reduced prescribing volume with shifts to newer agents or combination therapies.
  • Regulatory hurdles in emerging markets affecting pricing.

Opportunities:

  • Expansion into niche markets with high unmet needs such as resistant hypertension.
  • Development of fixed-dose combinations or novel delivery forms.
  • Strategic partnerships focusing on emerging markets with rising hypertension prevalence.

Key Takeaways

  • CALAN SR faces intense generic competition, resulting in declining revenues in mature markets.
  • Growth relies on expansion into emerging markets and possible reformulation strategies.
  • The market is consolidating around newer antihypertensive agents with better tolerability profiles.
  • Regulatory and pricing policies limit revenue potential in several regions.
  • R&D for CALAN SR largely lacks urgency; innovation focuses on combination therapies and delivery platforms.

FAQs

Q1: Does CALAN SR still hold a significant share in the antihypertensive market?
No, generic versions dominate due to patent expiration. CALAN SR's market share has declined, especially in North America and Europe.

Q2: Can CALAN SR benefit from new indications?
While verapamil has uses in arrhythmias, CALAN SR’s formulation has not secured new indications supported by recent trials, limiting growth potential.

Q3: How do regulatory policies influence CALAN SR revenues?
Price caps and reimbursement restrictions in major markets lower profit margins and can constrain sales volume.

Q4: Are there recent reformulations or patent extensions for CALAN SR?
No recent reformulations or secondary patents have extended exclusivity, leading to reliance on generics.

Q5: What are key strategies for maintaining profitability with CALAN SR?
Focusing on niche markets, developing fixed-dose combinations, and expanding into emerging markets could sustain revenues amid generic competition.


References

  1. MarketWatch. (2022). Global antihypertensive market forecast.
  2. WHO. (2021). Hypertension prevalence data.
  3. U.S. FDA. (2003). Patent and exclusivity information for verapamil formulations.
  4. IMS Health. (2022). Cardiology drug market share analysis.
  5. European Medicines Agency. (2020). Regulatory policies impacting antihypertensives.

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