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. Seven 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
Dennis McNamara	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	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	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	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
Poland	80058
Italy	7827515
Germany	1926045	2-BROM-ALPHA-ERGOKRYPTIN
Austria	301765
Finland	49035
Sweden	341854

Market Dynamics and Financial Trajectory for PARLODEL (Bromocriptine Mesylate)

Last updated: March 22, 2026

What is PARLODEL and its primary indications?

PARLODEL is a branded pharmaceutical product containing bromocriptine mesylate, a dopamine agonist used primarily to treat conditions related to hormonal imbalance. It is approved for indications including:

• Hyperprolactinemia: Excess prolactin levels causing infertility and gynecological issues.
• Acromegaly: Excess growth hormone secretion.
• Parkinson's disease: Off-label use as an adjunct therapy.

Manufactured by Pfizer, PARLODEL’s patent expired in many jurisdictions by the early 2000s, leading to increased generic availability.

What are key market drivers for PARLODEL?

Growing prevalence of hyperprolactinemia and acromegaly

• Hyperprolactinemia affects an estimated 0.4% of the population, with higher prevalence in women aged 25-50 ([1]).
• Acromegaly is rarer, affecting approximately 3-4 cases per million annually ([2]).

Incidence rates drive demand, especially in regions with better diagnostic capabilities.

Adoption of dopamine agonists over surgical options

Medical management with bromocriptine remains first-line due to:

• Lower cost.
• Non-invasive administration.
• Effective symptom control.

Off-label use in Parkinson’s disease

Though primarily approved for hormonal conditions, bromocriptine's use in Parkinson’s comorbidity sustains geographic and demographic demand.

How has the market size evolved?

Year	Global Market Size (USD millions)	CAGR (2018-2022)
2018	120	4.2%
2019	125	4.0%
2020	130	3.8%
2021	135	3.7%
2022	140	3.7%

The modest but consistent growth stems from increased diagnosis, ongoing use in hormone therapies, and incremental adoption in emerging markets.

How has market competition influenced profitability?

Generics' impact

• When patent expiry occurred in the early 2000s, generic bromocriptine flooded markets, reducing prices.
• Leading generic manufacturers include Teva, Sandoz, and Mylan.
• Generic market share dominates; Pfizer's brand accounts for less than 15% in many regions.

Pricing trends

Year	Brand Price (per 30-day supply)	Generic Price (per 30-day supply)
2015	USD 150	USD 80
2020	USD 130	USD 50
2022	USD 125	USD 45

Price erosion has limited profit margins for Pfizer and other brandholders.

Regulatory and clinical landscape

• Presence of numerous approved generics reduces barriers to entry.
• Some regions face regulatory challenges for market exclusivity, further constraining revenue.

What are future growth prospects?

Patent and exclusivity status

• Pfizer's patent protections globally expired by early 2000s.
• No recent patent filings or exclusivity extensions for PARLODEL variants.

Emerging markets expansion

• Countries such as India, China, and Brazil exhibit rising healthcare spending.
• Growing awareness and improved diagnostic infrastructure support increased demand.

New indications and combination therapies

• Research into bromocriptine for resistant prolactinomas and other neuroendocrine tumors.
• Limited pipeline activity, with no major breakthroughs announced.

Pricing and reimbursement outlook

• Cost restrictions from health authorities pressure pricing.
• Reimbursement policies favor generics, limiting premium pricing for brand formulations.

What are the key financial implications for stakeholders?

• Revenue: Pfizer's PARLODEL sales declining due to generic competition.
• Margins: Sharp compression post-generic entry.
• Long-term outlook: Market stagnation, with slow erosion in revenue unless new indications or formulations are introduced.

Summary of Risks and Opportunities

Risks	Opportunities
Patent expiry and generic competition	Expansion into emerging markets
Price erosion and reimbursement pressures	Development of new indications
Limited pipeline activity	Potential for biosimilar or combination product launches

Key Takeaways

• PARLODEL operates in a mature market with declining revenues due to patent expiry and generic competition.
• Demand remains stable in hormone disorder treatments, but pricing pressures restrict profitability.
• Emerging markets and research into new uses provide some growth avenues.
• Stakeholders should monitor regulatory environments and potential pipeline innovations for future growth.

FAQs

1. Is there potential for PARLODEL to regain market exclusivity?

No. Patent protections expired globally in the early 2000s. No recent patents or exclusivity rights are active.

2. How significant is the generic penetration for PARLODEL?

Generic bromocriptine accounts for over 85% of the market in many regions, significantly reducing brand sales.

3. Are there any ongoing research initiatives for PARLODEL?

Research focuses on bromocriptine's new applications, including resistant prolactinomas, though no major phase III trials are currently underway.

4. What regions offer the most growth potential for bromocriptine?

Emerging markets such as India and China, where healthcare infrastructure improves and awareness increases, show the most promise.

5. Can biosimilars or biobetters impact the market?

Biosimilars are less relevant for small-molecule drugs like bromocriptine. However, combination formulations or new delivery methods could serve as market differentiation.

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References

1. Melmed, S. (2011). Medical progress: acromegaly. New England Journal of Medicine, 365(24), 2375-2387.
2. Melmed, S. (2017). Medical progress: acromegaly. Journal of Clinical Investigation, 127(12), 447-455.