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. Eight 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:	54
Clinical Trials:	10
Patent Applications:	3,236
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
Spain	367828
Denmark	124884
Switzerland	507249	Verfahren zur Herstellung von 2-Brom-a-ergokryptin
Cyprus	780	BROMO-ERGOCRYPTINE
France	2009737

PARLODEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Parlodel

Introduction

Parlodel, also known as bromocriptine, is a medication with a diverse range of clinical applications, including the treatment of hyperprolactinemia, acromegaly, and Parkinson's disease. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Clinical Indications and Market Segments

Parlodel is indicated for several medical conditions, each representing a distinct market segment:

• Hyperprolactinemia: This condition involves high levels of prolactin, leading to symptoms such as galactorrhea, amenorrhea, infertility, and hypogonadism. The drug is effective in reducing prolactin levels and shrinking prolactin-secreting tumors[1][2][5].
• Acromegaly: Parlodel is used to treat this condition by reducing serum growth hormone levels. It can be used alone or as adjunctive therapy with other treatments like pituitary irradiation or surgery[2][5].
• Parkinson's Disease: The drug is used as an adjunctive treatment to levodopa, helping to manage symptoms such as tremors, stiffness, and slowness of movement[2][5].

Market Size and Growth

The market size for Parlodel is influenced by the prevalence of its target conditions and the availability of alternative treatments.

• Hyperprolactinemia: The market for hyperprolactinemia treatments is significant due to the condition's relatively high prevalence. Effective management of prolactin levels with Parlodel contributes to its market share.
• Acromegaly: Although acromegaly is a rare condition, the lack of alternative treatments makes Parlodel a key player in this market segment.
• Parkinson's Disease: The Parkinson's disease market is substantial, and Parlodel's role as an adjunctive therapy to levodopa positions it as a valuable treatment option.

Competitive Landscape

The competitive landscape for Parlodel includes other dopamine agonists and treatments specific to each condition:

• Hyperprolactinemia: Other dopamine agonists like cabergoline are competitors in this space. However, Parlodel's long-standing presence and efficacy give it a strong market position[2].
• Acromegaly: Treatments such as somatostatin analogs and pegvisomant compete with Parlodel, but its ability to reduce growth hormone levels makes it a preferred choice for many patients[5].
• Parkinson's Disease: Levodopa and other dopamine agonists like pramipexole and ropinirole are key competitors. However, Parlodel's unique profile and adjunctive use with levodopa maintain its market relevance[5].

Financial Performance

The financial performance of Parlodel is influenced by several factors, including sales volume, pricing, and market competition.

• Sales Volume: The drug's sales are driven by its widespread use across multiple indications. Consistent demand, particularly in the treatment of hyperprolactinemia and Parkinson's disease, contributes to stable sales volumes.
• Pricing: The pricing of Parlodel can vary by region and is influenced by regulatory environments, healthcare policies, and competition. Generally, it is priced competitively with other dopamine agonists.
• Revenue Trends: Historical data shows that Parlodel has maintained a steady revenue stream due to its established market presence and the ongoing need for its therapeutic benefits.

Regulatory and Safety Considerations

Regulatory and safety issues can significantly impact the financial trajectory of a drug:

• Withdrawal from Certain Markets: Concerns over rare cardiovascular and cerebrovascular accidents led to the removal of Parlodel from the market for postpartum lactation suppression. This decision affected its revenue in that specific market segment[4].
• Safety Monitoring: Long-term and high-dose use of Parlodel has been associated with side effects such as pleural and pericardial effusions, retroperitoneal fibrosis, and intense urges to gamble or spend money uncontrollably. These risks necessitate careful patient monitoring and can influence prescribing practices[3][5].

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of Parlodel:

• Efficacy and Safety Profile: The drug's efficacy in reducing prolactin and growth hormone levels, along with its safety profile when used appropriately, makes it a preferred choice for many prescribers.
• Convenience and Compliance: The availability of Parlodel in various formulations (capsules and tablets) and its dosing regimens (e.g., once or twice daily) enhance patient compliance and satisfaction[1][2].

Future Outlook

The future outlook for Parlodel is influenced by several factors:

• Emerging Treatments: The development of new treatments for hyperprolactinemia, acromegaly, and Parkinson's disease could potentially impact Parlodel's market share.
• Generic Competition: The availability of generic versions of bromocriptine can reduce the revenue of the branded product.
• Regulatory Changes: Changes in regulatory policies or safety guidelines can affect the drug's market position.

Key Takeaways

• Diverse Clinical Indications: Parlodel's use in treating hyperprolactinemia, acromegaly, and Parkinson's disease ensures a broad market presence.
• Established Market Position: The drug's long history and efficacy contribute to its stable market share.
• Regulatory and Safety Considerations: Ongoing safety monitoring and regulatory compliance are crucial for maintaining its market position.
• Competitive Landscape: The presence of other dopamine agonists and condition-specific treatments necessitates continuous market vigilance.

FAQs

What are the primary indications for Parlodel?

Parlodel is primarily indicated for the treatment of hyperprolactinemia, acromegaly, and Parkinson's disease.

How is Parlodel administered?

Parlodel is available in capsule and tablet forms and is taken orally, with dosing regimens varying depending on the condition being treated[1][2].

What are the common side effects of Parlodel?

Common side effects include nausea, hallucinations, and intense urges to gamble or spend money uncontrollably. Rare but serious side effects include pleural and pericardial effusions, retroperitoneal fibrosis, and cardiovascular events[3][5].

Has Parlodel been withdrawn from any markets?

Yes, due to concerns over rare cardiovascular and cerebrovascular accidents, Parlodel was removed from the market for postpartum lactation suppression[4].

How does Parlodel compare to other dopamine agonists?

Parlodel's efficacy and safety profile, along with its long-standing market presence, position it competitively against other dopamine agonists like cabergoline and pramipexole[2][5].

Sources

1. MedlinePlus: Bromocriptine: MedlinePlus Drug Information.
2. NPS MedicineWise: Parlodel - NPS MedicineWise.
3. FDA: Parlodel - accessdata.fda.gov.
4. PubMed: Clinical commentary: the bromocriptine (Parlodel) controversy and ...
5. FDA: Parlodel® SnapTabs® (bromocriptine mesylate) tablets, USP.