CENESTIN Drug Patent Profile

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

Cenestin is a drug marketed by Aspen and is included in one NDA.

The generic ingredient in CENESTIN is estrogens, conjugated synthetic a. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic a profile page.

Summary for CENESTIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	1
Patent Applications:	1,042
What excipients (inactive ingredients) are in CENESTIN?	CENESTIN excipients list
DailyMed Link:	CENESTIN at DailyMed

See drug sales revenues for CENESTIN

Recent Clinical Trials for CENESTIN

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

Sponsor	Phase
Duramed Research	Phase 3

See all CENESTIN clinical trials

Paragraph IV (Patent) Challenges for CENESTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CENESTIN	Tablets	estrogens, conjugated synthetic a	0.3 mg, 0.45 mg and 0.9 mg	020992	1	2009-03-19
CENESTIN	Tablets	estrogens, conjugated synthetic a	0.625 mg	020992	1	2009-03-02
CENESTIN	Tablets	estrogens, conjugated synthetic a	1.25 mg	020992	1	2008-11-03

US Patents and Regulatory Information for CENESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-001	Jun 21, 2002		DISCN	Yes	No
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-003	Mar 24, 1999		DISCN	Yes	No
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-005	Feb 5, 2004		DISCN	Yes	No
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-002	Mar 24, 1999		DISCN	Yes	No
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-004	Mar 13, 2000		DISCN	Yes	No

Expired US Patents for CENESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-004	Mar 13, 2000
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-001	Jun 21, 2002
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-003	Mar 24, 1999
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-002	Mar 24, 1999
Aspen	CENESTIN	estrogens, conjugated synthetic a	TABLET;ORAL	020992-005	Feb 5, 2004

International Patents for CENESTIN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9704753
World Intellectual Property Organization (WIPO)	9704752
China	100421652
Taiwan	457092
China	1197387

CENESTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CENESTIN

Introduction

CENESTIN, a synthetic conjugated estrogen product, is used to treat moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause. Understanding the market dynamics and financial trajectory of CENESTIN involves analyzing its clinical use, market competition, pricing strategies, and the broader economic context of pharmaceutical development.

Clinical Use and Indications

CENESTIN is a blend of nine synthetic estrogenic substances, designed to replace hormones lost during and after menopause. It is used for the treatment of moderate to severe vasomotor symptoms and symptoms of vulvar and vaginal atrophy due to menopause[1][4].

Market Competition

The market for hormone replacement therapy (HRT) is competitive, with various products available, including both synthetic and naturally occurring estrogens. CENESTIN competes with other HRT products, some of which may be preferred due to their natural composition or specific formulations. The choice of HRT product often depends on the patient's specific needs and the prescribing physician's preferences.

Pricing Strategies

The pricing of CENESTIN, like other pharmaceuticals, is influenced by several factors, including the cost of research and development, production costs, market demand, and regulatory environments. For drugs targeting smaller patient populations, such as some menopausal symptoms, firms may adopt higher pricing strategies to justify the significant investment in R&D and to ensure profitability[3].

Economic Implications of Precision Medicines

The shift towards precision medicines, which target specific patient populations, has economic implications for drugs like CENESTIN. While CENESTIN is not a precision medicine per se, the trend towards more targeted therapies can influence the overall market dynamics. Firms may prioritize products that generate high value for smaller patient populations, leading to higher prices and potentially reduced competition from generic or therapeutic substitutes[3].

Adverse Reactions and Safety Profile

The safety profile of CENESTIN is an important factor in its market dynamics. Clinical trials have shown various adverse reactions, including abdominal pain, asthenia, headache, and others. These side effects can impact patient compliance and physician prescribing habits, influencing the drug's market performance[1].

Regulatory Considerations

Regulatory environments play a crucial role in the financial trajectory of pharmaceuticals. For CENESTIN, regulatory approvals and guidelines on the use of HRT products are essential. For instance, the FDA may issue guidelines on the use of HRT for specific indications, which can affect market demand and pricing strategies.

Financial Performance and Revenue

While specific financial data for CENESTIN is not readily available, the overall financial performance of pharmaceutical companies can provide insights. The revenue generated by HRT products is influenced by factors such as prescription rates, insurance coverage, and patient adherence. Companies that produce HRT products often report revenues within their broader therapeutic categories, making it challenging to isolate the financial performance of a single product like CENESTIN.

Impact of Generic Competition

Generic competition is a significant factor in the pharmaceutical market. However, for drugs targeting smaller patient populations or those with complex formulations, generic entry may be less likely. CENESTIN, being a synthetic conjugated estrogen product, might face less generic competition compared to simpler formulations, which could help maintain its market share and pricing power[3].

Patient Population and Market Size

The market size for CENESTIN is determined by the number of postmenopausal women experiencing moderate to severe vasomotor symptoms and vulvar and vaginal atrophy. This patient population is significant, but the market is also influenced by alternative treatments and lifestyle changes that patients may adopt to manage their symptoms.

Pricing and Profitability

The pricing of CENESTIN is critical to its profitability. Given the high R&D costs and the need to generate returns on investment, pharmaceutical companies often set prices that balance revenue goals with patient affordability and market competition. For CENESTIN, the pricing strategy must consider the value it provides to patients and the competitive landscape of HRT products.

Future Outlook

The future outlook for CENESTIN depends on several factors, including advances in menopausal treatment options, changes in regulatory environments, and shifts in patient preferences. As the pharmaceutical industry continues to evolve, with a focus on precision medicines and personalized healthcare, CENESTIN may need to adapt to remain competitive.

Key Statistics

• Adverse Reactions: In clinical trials, CENESTIN showed a high incidence of adverse reactions, with headache and asthenia being among the most common[1].
• Market Competition: The HRT market is competitive, with various synthetic and natural estrogen products available[4].
• Pricing Strategies: Higher pricing for targeted therapies can justify R&D investments and ensure profitability[3].

"The increasing percentage of LPMs (Large Patient Markets) in pharmaceutical development has clear economic ramifications. ... Firms will only bring to market products that generate large amounts of value for individuals with those conditions. For such products, the potential value created leads to an expected price and resulting profits that justify the research and development investments."[3]

Key Takeaways

• Clinical Use: CENESTIN is used to treat moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause.
• Market Competition: The HRT market is competitive, with various products available.
• Pricing Strategies: Pricing is influenced by R&D costs, market demand, and regulatory environments.
• Regulatory Considerations: Regulatory approvals and guidelines impact market demand and pricing.
• Financial Performance: Revenue is influenced by prescription rates, insurance coverage, and patient adherence.
• Generic Competition: Less likely for complex formulations like CENESTIN.
• Patient Population: Significant but influenced by alternative treatments and lifestyle changes.

FAQs

What are the primary indications for CENESTIN?

CENESTIN is primarily used to treat moderate to severe vasomotor symptoms and symptoms of vulvar and vaginal atrophy due to menopause.

What are the common adverse reactions associated with CENESTIN?

Common adverse reactions include headache, asthenia, abdominal pain, and various gastrointestinal symptoms.

How does CENESTIN compete in the HRT market?

CENESTIN competes with other HRT products, both synthetic and natural, and its market position is influenced by its specific formulation and patient preferences.

What factors influence the pricing of CENESTIN?

Pricing is influenced by R&D costs, production costs, market demand, and regulatory environments.

Is generic competition a significant threat to CENESTIN?

Generic competition is less likely for complex formulations like CENESTIN, which helps maintain its market share and pricing power.

What is the future outlook for CENESTIN?

The future outlook depends on advances in menopausal treatment options, changes in regulatory environments, and shifts in patient preferences.

Sources

1. RxList: Cenestin (Synthetic conjugated estrogens) - RxList
2. Tenet Healthcare: Tenet Reports Results for the Fourth Quarter and Year Ended December 31, 2019 and Issues Financial Outlook for 2020
3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market
4. DrugBank: Synthetic Conjugated Estrogens, A - DrugBank