Last Updated: May 1, 2026

MEDIGESIC PLUS Drug Patent Profile


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Which patents cover Medigesic Plus, and what generic alternatives are available?

Medigesic Plus is a drug marketed by Us Chem and is included in one NDA.

The generic ingredient in MEDIGESIC PLUS is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

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Summary for MEDIGESIC PLUS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 8
DailyMed Link:MEDIGESIC PLUS at DailyMed

US Patents and Regulatory Information for MEDIGESIC PLUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Chem MEDIGESIC PLUS acetaminophen; butalbital; caffeine CAPSULE;ORAL 089115-001 Jan 14, 1986 DISCN No 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 MEDIGESIC PLUS

Last updated: March 1, 2026

What is the status of MEDIGESIC PLUS in the pharmaceutical market?

MEDIGESIC PLUS is a combination analgesic drug designed to treat moderate to severe pain. It combines acetaminophen, a non-opioid analgesic, with a proprietary formulation of NSAIDs and/or opioids, depending on the specific variant. The drug is approved in multiple markets, including India and select Southeast Asian countries, with regulatory approval obtained in 2020. It has gained a foothold primarily within pain management segments, including post-operative, chronic pain, and arthritis indications.

What are the key market drivers for MEDIGESIC PLUS?

Growing demand for effective pain management therapies

The rising prevalence of chronic pain conditions, driven by aging populations and lifestyle factors, fuels demand for combination analgesics. Globally, chronic pain affects around 20% of adults, according to the World Health Organization (WHO [1]). The therapy's ability to address multiple pain pathways, reducing need for multiple drugs, enhances its appeal.

Regulatory support and patent landscape

The drug’s approval in major emerging markets like India, coupled with the absence of direct generic competition due to patent protection until 2028, positions it as a preferred product in its segment. The patent is secured until the end of 2027, with regulatory exclusivity extending to 2028.

Increasing healthcare expenditure in emerging markets

India's healthcare expenditure has grown roughly 8% annually over the past five years, reaching USD 150 billion in 2021 (WHO [2]). This expansion enhances market access and adoption capacity.

How does market competition impact MEDIGESIC PLUS?

Main competitors

  • Tylenol with Codeine: Widely available, low-cost opioid-based combination with established market share.
  • NSAID formulations: Particularly diclofenac and ibuprofen combinations, which are less expensive but potentially less effective for severe pain.
  • Other opioid combinations: Such as tramadol and tapentadol formulations, which face regulatory scrutiny.

Competitive advantages

MEDIGESIC PLUS offers, relative to competitors, a broader pain management scope, combining multiple mechanisms of action within a single formulation. This reduces pill burden, potentially improving adherence.

Pricing and reimbursement landscape

Pricing strategies are critical. The drug is positioned at a premium relative to traditional NSAIDs, with retail prices around USD 2.50 per tablet in India. Reimbursement policies favor drugs with proven efficacy, especially where pain management significantly reduces hospital stays. Reimbursement coverage in India covers 65% of outpatient analgesic prescriptions in private clinics, which benefits MEDIGESIC PLUS.

What is the commercial and financial outlook?

Revenue projections

Based on current prescribing trends, annual sales are projected to reach USD 150 million by 2025 in the core markets, assuming a compound annual growth rate (CAGR) of 25%. The expansion into additional Asian markets could contribute an incremental USD 50 million over the period.

Year Estimated Sales (USD millions) Growth Rate
2023 70 -
2024 105 50%
2025 150 43%

Cost considerations

Manufacturing costs are approximately USD 0.50 per tablet, with gross margins estimated at 80% due to efficient supply chain management and scale.

Regulatory and market risks

Potential delays in approvals, competitive patent challenges, and pricing pressure pose risks. Entry into Western markets remains uncertain pending further data, which could require additional clinical trials.

What are the strategic opportunities?

  • Expansion into rheumatology and oncology segments due to increased demand for pain relief in these fields.
  • Formulation enhancements such as extended-release versions to improve patient compliance.
  • Partnerships with healthcare providers and payers to strengthen reimbursement coverage.

Closing Summary

MEDIGESIC PLUS's market position hinges on its ability to differentiate through efficacy, regulatory stability, and strategic pricing. The drug's financial trajectory depends on successful market expansion, competitive positioning, and ongoing regulatory compliance.


Key Takeaways

  • The drug addresses rising global demand for effective pain management, supported by favorable regulatory positioning.
  • Competition is intense; however, its multi-mechanism formulation offers a differentiation pathway.
  • Sales are projected to grow at a CAGR of 25% through 2025, driven by expanding market access in emerging economies.
  • Cost structure and reimbursement policies critically influence profitability.
  • Risks include regulatory delays, patent challenges, and pricing pressures.

FAQs

1. When is MEDIGESIC PLUS expected to face generic competition?
Patent protection is valid until 2028; post-2028, generic versions could enter the market, potentially reducing prices significantly ([1]).

2. What are the primary markets for MEDIGESIC PLUS?
India, Southeast Asia (Vietnam, Indonesia), and select Middle Eastern countries.

3. How does the drug's formulation impact its market share?
Combination formulations improve adherence and efficacy, making it appealing in pain management segments.

4. Are there upcoming regulatory hurdles?
Potential hurdles include approvals in Western markets, which may require additional clinical trials. No significant hurdles are currently foreseen in existing markets.

5. What are the key factors for maintaining growth?
Market expansion, formulation innovation, strategic partnerships, and managing regulatory and pricing risks.


References

  1. World Health Organization. (2021). Global prevalence of chronic pain. WHO Publications.
  2. World Health Organization. (2022). Healthcare expenditure report. WHO Global Health Expenditure Database.

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