PROPECIA Drug Patent Profile

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

Propecia is a drug marketed by Organon and is included in one NDA.

The generic ingredient in PROPECIA is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Propecia

A generic version of PROPECIA was approved as finasteride by DR REDDYS LABS INC on July 28^th, 2006.

Summary for PROPECIA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	10
Patent Applications:	3,500
Drug Prices:	Drug price information for PROPECIA
What excipients (inactive ingredients) are in PROPECIA?	PROPECIA excipients list
DailyMed Link:	PROPECIA at DailyMed

See drug prices for PROPECIA

See drug sales revenues for PROPECIA

Recent Clinical Trials for PROPECIA

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

Sponsor	Phase
Follicle Pharma Ltd	Phase 1
Inventage Lab., Inc.	Phase 1/Phase 2
Polichem S.A.	Phase 3

See all PROPECIA clinical trials

Pharmacology for PROPECIA

Drug Class	5-alpha Reductase Inhibitor
Mechanism of Action	5-alpha Reductase Inhibitors

US Patents and Regulatory Information for PROPECIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	AB	RX	Yes	Yes

Expired US Patents for PROPECIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,886,184
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	4,377,584
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,571,817
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,547,957
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	4,760,071

International Patents for PROPECIA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2072848
Japan	S63139196	17 BETA-ACYL-4-AZA-5 ALPHA-ANDROST-1-ENE-3-ONES BEING 5 ALPHA REDUCTASE INHIBITOR
Slovenia	9300603	Novi postopki za pridobivanje finasterida (NEW PROCESSES FOR FINASTERIDE PRODUCTION)
Bulgaria	62362
Algeria	1733	Nouveaux procédés d'obtention de finastéride.

Supplementary Protection Certificates for PROPECIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0155096	SPC/GB93/006	United Kingdom		SPC/GB93/006:, EXPIRES: 20070526
0155096	93C0055	Belgium		PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527

PROPECIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Propecia (Finasteride)

Introduction

Propecia, the brand name for the drug finasteride, has been a significant player in the market for treating male pattern baldness and benign prostatic hyperplasia (BPH) since its introduction in the late 1990s. Here, we delve into the market dynamics and financial trajectory of Propecia, exploring its launch, marketing strategies, side effects, and current market trends.

Launch and Initial Marketing Strategies

When Propecia was launched in 1997 by Merck & Co., it faced several marketing challenges. The drug required a physician's prescription, which complicated direct-to-consumer advertising. Tom Casola, the marketing director at the time, had to decide whether to target balding men directly, focus on physicians, or influence other stakeholders like wives and barbers of balding men[1].

Direct-to-Consumer Advertising

Merck opted for a direct-to-consumer advertising strategy, despite the regulatory requirement to include major side effects in the ads. This approach was risky due to the less than 2% possibility of sexual dysfunction, which was a significant turnoff for potential consumers. However, the company believed it was necessary to create awareness and convince men that they had a problem that Propecia could solve[1].

Brand Awareness

The marketing efforts were highly successful in terms of brand awareness. Even before the marketing campaign began, Propecia had a 35% ambient awareness. By the end of the first year, this had skyrocketed to 90% brand awareness, although some of this was driven by the publicity surrounding side effects[1].

Side Effects and Litigation

One of the major challenges Propecia faced was the issue of side effects. The drug is associated with sexual dysfunction, including decreased libido, erectile dysfunction, and ejaculation disorders. These side effects led to significant litigation against Merck.

Post-Finasteride Syndrome (PFS)

Since 2011, numerous lawsuits have been filed alleging that Merck failed to adequately warn users about the constellation of sexual and cognitive side effects known as Post-Finasteride Syndrome (PFS). The National Institutes of Health has added PFS to its rare-diseases database, and there have been reports of suicidal behavior and deaths associated with the drug[2].

Regulatory and Legal Issues

Internal company communications revealed that Merck may have understated the number of men experiencing sexual symptoms in clinical trials and the duration of these symptoms. This led to a judge unsealing documents related to the lawsuits, highlighting the public's right to access this information[2].

Financial Performance

Despite the challenges, Propecia has performed well financially. In its first year, the drug exceeded internal sales estimates due to pent-up demand, although the sales figures were lower than expected by Merck. Propecia is now a $250 million brand, indicating its significant market presence[1].

Market Growth

The global finasteride market, which includes Propecia, is expected to grow from USD 103.62 million in 2024 to USD 128.77 million by 2032, with a Compound Annual Growth Rate (CAGR) of 2.8%. This growth is driven by increasing demand for effective hair loss treatments and the expanding pharmaceutical sector[5].

Market Dynamics

Regional Demand

The demand for finasteride is high in regions where there is a strong focus on physical appearance. Europe, for example, has seen significant growth due to consumer preferences. China has also emerged as a key market, benefiting from the lower cost of finasteride drugs and the expansion of the pharmaceutical sector[3].

Distribution Channels

Retail pharmacies hold a substantial market share due to consumer familiarity and trust. However, the rise of telemedicine and online pharmacies is expected to drive future demand. Initiatives like Amazon's drug subscription scheme are making finasteride more accessible and affordable[5].

Competitive Landscape

The finasteride market is competitive, with key players including Accord Pharmaceuticals, Actavis, Cipla, Henan Topfond, Merck, and Mylan N.V. Market players are focusing on mergers and acquisitions, as well as the development of bio-pharmaceuticals, to gain a competitive edge[5].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the global finasteride market. Production halts and supply chain disruptions have affected the availability of the drug. However, the pandemic has also accelerated the adoption of telemedicine and online pharmacies, which could drive future growth[3].

Key Takeaways

• Brand Awareness and Marketing: Propecia's launch was marked by high brand awareness, but the inclusion of side effects in advertising posed significant challenges.
• Side Effects and Litigation: The drug has been associated with serious side effects, leading to extensive litigation and regulatory scrutiny.
• Financial Performance: Despite challenges, Propecia has achieved significant financial success, with a current market value of $250 million.
• Market Growth: The global finasteride market is expected to grow at a CAGR of 2.8% from 2024 to 2032.
• Regional Demand: Europe and China are key markets due to consumer preferences and lower drug costs.
• Distribution Channels: Retail pharmacies dominate, but online pharmacies and telemedicine are gaining traction.

FAQs

What were the main marketing challenges faced by Propecia during its launch?

Propecia faced challenges in direct-to-consumer advertising due to the need to include side effects in ads and the difficulty in targeting the right audience, such as balding men or their influencers like wives and barbers[1].

What are the significant side effects associated with Propecia?

Propecia is associated with sexual dysfunction, including decreased libido, erectile dysfunction, and ejaculation disorders. There have also been reports of suicidal behavior and cognitive side effects known as Post-Finasteride Syndrome (PFS)[2][4].

How has the COVID-19 pandemic affected the finasteride market?

The pandemic has disrupted production and supply chains, but it has also accelerated the adoption of telemedicine and online pharmacies, which could drive future growth in the market[3].

What is the projected growth of the global finasteride market?

The global finasteride market is expected to grow from USD 103.62 million in 2024 to USD 128.77 million by 2032, with a CAGR of 2.8%[5].

Who are the key players in the finasteride market?

Key players include Accord Pharmaceuticals, Actavis, Cipla, Henan Topfond, Merck, and Mylan N.V.[5].

Sources

1. Side Effects: The Case of Propecia - Working Knowledge, Harvard Business School.
2. Propecia Litigation Library - PFS Foundation.
3. Finasteride Market Will Expand as Demand for Effective Benign Prostate Hyperplasia Treatment Rises - Fact MR.
4. PROPECIA® (finasteride) tablets for oral use - FDA.
5. Finasteride Market Statistics, Growth & Competitive Analysis 2032 - Polaris Market Research.