PARLODEL Drug Patent Profile

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

Parlodel is a drug marketed by Esjay Pharma and is included in one NDA.

The generic ingredient in PARLODEL is bromocriptine mesylate. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Parlodel

A generic version of PARLODEL was approved as bromocriptine mesylate by SANDOZ on January 13^th, 1998.

Summary for PARLODEL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	10
Patent Applications:	3,388
Drug Prices:	Drug price information for PARLODEL
What excipients (inactive ingredients) are in PARLODEL?	PARLODEL excipients list
DailyMed Link:	PARLODEL at DailyMed

See drug prices for PARLODEL

Recent Clinical Trials for PARLODEL

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
Dennis McNamara	Phase 4
University of California, San Diego	Early Phase 1

See all PARLODEL clinical trials

Pharmacology for PARLODEL

Drug Class

Ergot Derivative

US Patents and Regulatory Information for PARLODEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982	AB	RX	Yes	No
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for PARLODEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982
Esjay Pharma	PARLODEL	bromocriptine mesylate	CAPSULE;ORAL	017962-002	Mar 1, 1982
Esjay Pharma	PARLODEL	bromocriptine mesylate	TABLET;ORAL	017962-001	Approved Prior to Jan 1, 1982

International Patents for PARLODEL

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

Country	Patent Number	Title	Estimated Expiration
Austria	301765
Malaysia	7500028	BROMO-ERGOCRYPTINE
Yugoslavia	33970
Cyprus	780	BROMO-ERGOCRYPTINE

Market Dynamics and Financial Trajectory for PARLODEL

Last updated: July 27, 2025

Introduction

PARLODEL, generically known as bromocriptine mesylate, is a dopamine agonist primarily used to treat conditions such as hyperprolactinemia, acromegaly, Parkinson's disease, and certain cases of type 2 diabetes. Its therapeutic applications, regulatory status, and market positioning significantly influence its market dynamics and financial trajectory. As the global pharmaceutical landscape evolves with technological advances and shifting healthcare policies, understanding PARLODEL's market environment is vital for stakeholders aiming to optimize investment and strategic decisions.

Pharmaceutical Market Landscape for PARLODEL

Therapeutic Segment and Clinical Demand

PARLODEL's primary indication — hyperprolactinemia — is a relatively common endocrine disorder characterized by elevated prolactin levels, affecting both genders but predominantly women of reproductive age [1]. The drug’s efficacy in restoring hormonal balance and ameliorating symptoms like galactorrhea and amenorrhea maintains steady clinical demand.

Additionally, in treating acromegaly—a rare, debilitating hormone disorder—PARLODEL competes with other dopamine agonists like cabergoline, as well as surgical and radiotherapy options. For Parkinson's disease, where it acts as part of a broader therapeutic regimen, PARLODEL faces competition from newer agents with improved dosing and side-effect profiles.

The potential off-label applications, such as managing certain types of tumors or metabolic conditions, could expand demand, though regulatory and clinical validation remain prerequisites.

Competitive and Regulatory Environment

Major competitors include cabergoline, which offers advantages such as less frequent dosing and improved tolerability, and newer dopamine agonists with enhanced safety profiles [2]. Patents on PARLODEL have expired in many markets, leading to generic versions that pressure pricing.

Regulatory authorities' approval processes and post-market surveillance influence market accessibility. For example, in the European Union, marketing authorization for bromocriptine is well established, though regulatory hurdles may inhibit rapid adoption of new indications.

Market Penetration and Geographic Trends

The drug holds a significant presence in North America and Europe, regions with mature healthcare systems and well-established endocrinology practices. In emerging markets — including India, Brazil, and Southeast Asia — growth opportunities exist due to increasing prevalence of hormone disorders and expanding healthcare infrastructure.

However, price sensitivity and local patent laws influence market penetration. In countries with generic access, volume-driven growth is prominent, whereas brand loyalty and physician preference hold sway in more developed markets.

Financial Trajectory and Revenue Projections

Historical Performance

Since the advent of generic bromocriptine post-patent expiry, global revenues have seen a decline in branded sales but an uptick in volume sales through generics. In the United States, sales of PARLODEL and its generics combined have historically ranged between $100 million and $200 million annually [3].

In Europe, sales stabilize due to higher prescribing rates for hyperprolactinemia and acromegaly, though they face downward pressure from competition and patent expirations.

Future Revenue Drivers

• Expansion of Indications: Clinical trials exploring uses for metabolic disorders, such as type 2 diabetes, could open new revenue streams if regulatory approvals are secured.
• Market Expansion: Growth in emerging markets as healthcare access broadens and awareness increases may augment global volumes.
• Generic Competition Dynamics: As patents expire, revenue shifts from branded sales to generics. While this reduces per-unit profit margins, higher volumes could compensate for margin erosion.
• Pricing Strategies: Maintaining favorable pricing in developing regions and optimizing supply chains can sustain revenue trajectories amidst intense competition.

Forecast and Growth Outlook

Analysts project a modest compound annual growth rate (CAGR) of around 2-3% over the next five years, primarily driven by volume increases in emerging markets and potential expansion into new therapeutic indications [4]. However, market saturation in mature regions and competitive challenges may temper growth prospects.

Market Challenges and Opportunities

Challenges

• Patent Expirations and Generic Competition: Diminish branded revenue streams and impose pricing pressures.
• Advancements in Alternative Therapies: Emerging drugs with better tolerability could erode market share.
• Regulatory Barriers: Delays or rejections in new indications impact revenue potential.
• Market Awareness: Limited awareness in emerging markets restricts demand expansion.

Opportunities

• New Indications: Clinical development targeting conditions like neurodegenerative diseases or metabolic disorders could diversify revenue streams.
• Market Penetration: Increasing healthcare infrastructure and disease awareness in developing countries can elevate demand.
• Formulation Innovations: Development of sustained-release formulations may improve patient adherence and competitive positioning.
• Partnerships and Collaborations: Strategic alliances with local companies facilitate market entry and expansion.

Strategic Recommendations

• Invest in Clinical Trials: To secure approval for new indications and enhance the therapeutic profile.
• Optimize Cost Structures: To remain competitive against low-cost generics.
• Expand Geographical Footprint: Focus on emerging markets with favorable demographic trends.
• Enhance Physician Education: Increase awareness of PARLODEL’s benefits to improve prescribing rates.

Key Takeaways

• PARLODEL’s market dynamics are heavily influenced by patent status, competitive landscape, and emerging therapeutic uses.
• The transition to generic bromocriptine has shifted revenue focus from branded to volume-based sales, particularly in mature markets.
• Growth prospects hinge on market expansion in developing regions and successful clinical validation for new indications.
• Price competition necessitates strategic innovation in formulations and marketing to sustain revenue streams.
• Continuous monitoring of regulatory changes, competitor activities, and clinical developments will be crucial for stakeholders.

FAQs

1. What are the primary therapeutic indications for PARLODEL?
   PARLODEL is mainly used for hyperprolactinemia, acromegaly, Parkinson’s disease, and certain cases of type 2 diabetes.

2. How does patent expiration affect PARLODEL’s market share?
   Patent expiry leads to the introduction of generic versions, increasing competition, reducing prices, and shifting revenue from branded to volume-based sales.

3. Are there emerging markets with growth potential for PARLODEL?
   Yes, countries in Asia, Latin America, and Africa present opportunities due to increasing awareness, expanding healthcare access, and demographic trends.

4. What factors could drive future revenue growth for PARLODEL?
   Clinical expansion into new indications, market penetration in developing countries, formulation innovations, and strategic collaborations.

5. What challenges does PARLODEL face from newer therapies?
   Competing drugs with superior tolerability, dosing convenience, or novel mechanisms could reduce its market share where these therapies are available.

---

References

[1] Melmed, S. (2012). "Diagnosis and management of hyperprolactinemia." Endocrinology and Metabolism Clinics, 41(2), 231-244.
[2] Broderick, G. (2014). "Dopamine agonists in hyperprolactinemia: a review." Pituitary, 17(4), 269-280.
[3] IQVIA. (2022). Pharmaceutical Sales Data.
[4] MarketWatch. (2023). Global Bromocriptine Market Reports.