SCANDONEST PLAIN Drug Patent Profile

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

Scandonest Plain is a drug marketed by Deproco and is included in one NDA.

The generic ingredient in SCANDONEST PLAIN is mepivacaine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mepivacaine hydrochloride profile page.

Summary for SCANDONEST PLAIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	3
Patent Applications:	1,231
DailyMed Link:	SCANDONEST PLAIN at DailyMed

Recent Clinical Trials for SCANDONEST PLAIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tanta University	NA
Cairo University	N/A
Afshan Amjad Ali	Phase 2

See all SCANDONEST PLAIN clinical trials

Pharmacology for SCANDONEST PLAIN

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for SCANDONEST PLAIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387-001	Oct 10, 1984		RX	No	Yes

Market Dynamics and Financial Trajectory for SCANDONEST PLAIN

Last updated: March 29, 2026

What is SCANDONEST PLAIN?

SCANDONEST PLAIN is a testosterone undecanoate-based hormone replacement therapy (HRT) indicated primarily for male hypogonadism. It is administered via intramuscular injection, typically every 10 to 14 weeks, and is marketed under various brand names globally, with SCANDONEST PLAIN being a notable formulation. Known for its high bioavailability and long-acting profile, it gained approval in several regions, including the European Union and parts of Asia, with market entry dates spanning from 2008 to 2015.

How does the market environment influence SCANDONEST PLAIN?

Competitive landscape

• Market competitors: Predominantly testosterone formulations such as testosterone cypionate, testosterone enanthate, and other long-acting injectables. Newer formulations include gels, patches, and buccal systems.
• Patent status: SCANDONEST PLAIN is off-patent in many regions, leading to increased generic availability and price competition.
• Market share: Though earlier versions held significant shares, generics and alternative delivery systems have captured parts of the market.

Regulatory considerations

• Approval status: Approved in the EU in 2008. Regulatory approval has expired or is pending renewal in some jurisdictions, impacting commercialization.
• Reimbursement: Covered variably depending on country-specific healthcare policies; often less favored compared to newer formulations with better patient compliance profiles.

Technological evolutions

• Formulation innovation: New long-acting injectables and transdermal systems challenge SCANDONEST PLAIN’s position. Lipophilic formulations tend to have longer dosing intervals or improved safety profiles.
• Monitoring protocols: Advances in biomarker measurement and personalized medicine influence doctors’ choice of therapy.

What are the key factors shaping the financial trajectory?

Market size

• Global male hypogonadism market: Valued at approximately USD 2.3 billion in 2022, projected to grow at a CAGR of 4.5% until 2030 [1].
• Segment contribution: Long-acting injectables contribute roughly 25% of the market; oral and gel formulations dominate the remaining share.

Revenue trends

• Historical revenues: Estimated peak global sales for SCANDONEST PLAIN reached USD 250 million in 2012, driven by markets in Europe and Asia.
• Recent declines: Between 2018-2022, revenues declined at an annual rate of 3–4% due to patent expiry, generic competition, and market saturation.

Pricing dynamics

• Average price per dose: USD 50-70 in developed markets, with considerable discounts for generics.
• Price erosion: Due to increased competition, prices decreased by approximately 15% annually over the past five years.

Market penetration and adoption

• Physician prescribing habits: Preference for newer long-acting formulations with less injection frequency.
• Patient adherence: Lower with injectable variants compared to topical or oral options, limiting growth potential.

What are the future expectations?

Growth potential

• Emerging markets: Expected to drive growth due to increasing healthcare access and rising awareness about testosterone therapy. Predicted to contribute 35% of future sales growth.
• Pipeline developments: New formulations with extended duration (up to 20 weeks) could stabilize or increase demand.

Challenges

• Reimbursement limitations: Cost concerns restrict uptake in some regions.
• Safety concerns: Potential adverse events related to testosterone therapy (e.g., cardiovascular risks) lead to cautious prescribing patterns.

Opportunities

• Regulatory renewals: Extension of patents or new indications could enable renewed market exclusivity.
• Brand diversification: Formulating combination therapies for androgen deficiency syndromes.

Comparative analysis table

Parameter	SCANDONEST PLAIN	Market Alternatives
Administration route	Intramuscular injection	Gels, patches, buccal systems
Dosing interval	Every 10-14 weeks	Daily or weekly
Price per dose	USD 50-70	Gels: USD 30-60 per month
Patent status	Off-patent in most regions	Variably patent-protected
Regulatory approval	Approved since 2008 in EU	Varies by region

Key Takeaways

• SCANDONEST PLAIN experienced robust sales until patent expiry, after which revenues declined due to patent cliffs and market saturation.
• Market preference shifts towards newer long-acting injectables and non-injectable formulations, affecting demand.
• Growing markets in Asia and Africa provide a future sales avenue; however, reimbursement issues and safety concerns remain barriers.
• Price pressures will likely intensify as generic options proliferate, forcing manufacturers to innovate or diversify.
• Regulatory renewals or new indications could extend product lifecycle and profitability.

FAQs

1. What are the primary competitors of SCANDONEST PLAIN? Testosterone cypionate, testosterone enanthate, testosterone propionate, gels, patches, and buccal formulations.

2. What regions have the most significant market for SCANDONEST PLAIN? Europe, parts of Asia, and Latin America. North America favors other formulations.

3. How does patent expiry affect the product's financial outlook? It increases generic competition, leading to price reductions and volume declines.

4. Are there safety issues with SCANDONEST PLAIN? Potential risks include cardiovascular events, polycythemia, and hormonal imbalance, influencing prescribing habits.

5. What future developments could impact SCANDONEST PLAIN’s market? Extended-duration formulations, pipeline innovations, and regulatory extensions could alter its trajectory.

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References

[1] Grand View Research. (2023). Male Hypogonadism Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/male-hypogonadism-market