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ANGELIQ Drug Patent Profile

Which patents cover Angeliq, and what generic alternatives are available?

Angeliq is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in sixteen countries.

The generic ingredient in ANGELIQ is drospirenone; estradiol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estradiol profile page.

DrugPatentWatch^® Generic Entry Outlook for Angeliq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 22, 2031. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ANGELIQ

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	7
Drug Prices:	Drug price information for ANGELIQ
What excipients (inactive ingredients) are in ANGELIQ?	ANGELIQ excipients list
DailyMed Link:	ANGELIQ at DailyMed

See drug prices for ANGELIQ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANGELIQ

Constraining patent/regulatory exclusivity:

8,906,890

NDA:

021355

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ANGELIQ

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Bayer
Bayer	Phase 2

See all ANGELIQ clinical trials

Pharmacology for ANGELIQ

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for ANGELIQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGELIQ	Tablets	drospirenone; estradiol	0.25 mg/0.5 mg	021355	1	2015-01-08
ANGELIQ	Tablets	drospirenone; estradiol	0.5 mg/1 mg	021355	1	2007-12-26

US Patents and Regulatory Information for ANGELIQ

ANGELIQ is protected by one US patents.

This potential generic entry date is based on patent 8,906,890.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No	8,906,890		Y
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005		RX	Yes	Yes

Expired US Patents for ANGELIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	6,933,395

International Patents for ANGELIQ

When does loss-of-exclusivity occur for ANGELIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Costa Rica

Eurasian Patent Organization

European Patent Office

Guatemala

Japan

Mexico

South Korea

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ANGELIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Guatemala	201200281	FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT
Slovenia	1149841
Hong Kong	1021190
Spain	2175451
Spain	2438941
Brazil	112012026115	formas de dosagem sólidas orais muito baixas para hrt

Supplementary Protection Certificates for ANGELIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0918791	PA2006009	Lithuania		PRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211

ANGELIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ANGELIQ

Introduction

ANGELIQ, a hormone therapy medication, is a combination of estradiol and drospirenone, designed to treat moderate to severe vasomotor symptoms and vaginal and vulvar atrophy in postmenopausal women with a uterus. Here, we delve into the market dynamics and financial trajectory of ANGELIQ, exploring its approval, market positioning, pricing, and future outlook.

Approval and Formulations

ANGELIQ was approved by the U.S. FDA in two formulations: the original 0.5 mg drospirenone (drsp)/1 mg estradiol (E2) and a lower dose formulation of 0.25 mg drsp/0.5 mg E2, approved in 2012. The lower dose formulation was introduced to align with guidelines recommending the use of the lowest effective dose of hormone therapy[1].

Market Positioning

ANGELIQ is unique in the hormone therapy market as it is the only product that combines estradiol with the progestin drospirenone. This differentiation is crucial, especially given the educational efforts by Bayer Women’s Health, such as partnering with menopause education organizations like Red Hot Mamas to raise awareness about menopausal symptoms and treatment options[4].

Competitive Landscape

The hormone therapy market is competitive, with several other products available, including Prempro, FemHRT, and Activella. However, ANGELIQ's specific combination of estradiol and drospirenone sets it apart. In terms of sales, while ANGELIQ is not the market leader, it holds a significant position. For example, in 2007, Prempro Low Dose and Prempro were among the top-selling hormone therapies, but ANGELIQ maintained a steady market presence[4].

Pricing and Cost Factors

The cost of ANGELIQ can vary significantly based on several factors:

• Dosage: Higher or more frequent doses result in higher costs. The medication comes in different dosages, and the pricing reflects these variations[5].
• Location: Drug prices vary across different states and pharmacies due to local market dynamics and cost of living differences[5].
• Pharmacy: Prices differ across pharmacies due to varying business models and agreements with pharmaceutical companies[5].
• Health Insurance: The coverage and out-of-pocket costs under different health insurance plans also impact the final cost to the patient[5].

As of November 2024, the average retail cost of ANGELIQ is $223.00 per month, although this can vary. Patient assistance programs, such as those offered by The Rx Advocates, can reduce the cost to as low as $80 per month for ANGELIQ alone[5].

Financial Performance and Projections

The financial performance of ANGELIQ is influenced by the broader trends in pharmaceutical expenditures. In 2023, overall pharmaceutical expenditures in the US grew by 13.6%, driven by increased utilization, new drugs, and price increases. For 2024, a growth of 10.0% to 12.0% in overall prescription drug spending is projected, with clinics and hospitals expected to see an 11.0% to 13.0% increase[3].

Historical Sales Data

Historical data shows that the hormone therapy market, including products like ANGELIQ, has experienced fluctuations. For instance, in the early 2000s, the market saw significant sales, with figures like $815,430,000 in 2002. However, sales declined in subsequent years, reflecting changes in market dynamics and consumer preferences[4].

Current Market Trends

The current market trends indicate a continued demand for hormone therapies, especially with the increasing awareness and education about menopausal symptoms. ANGELIQ's unique formulation and the support from educational campaigns are likely to maintain its market presence.

Safety and Efficacy

The safety and efficacy of ANGELIQ have been established through several clinical trials. These trials have shown that ANGELIQ provides endometrial protection and an acceptable bleeding profile. However, like other hormone therapies, it carries risks such as increased chances of heart attack, stroke, blood clots, and certain cancers[1][4].

Patient Assistance and Affordability Programs

To make ANGELIQ more accessible, various patient assistance and affordability programs are available. These programs help reduce the financial burden on patients, ensuring they can adhere to their treatment plans without significant financial strain[5].

Future Outlook

The future outlook for ANGELIQ is positive, given the ongoing need for effective hormone therapies. As the population ages and awareness about menopausal symptoms increases, the demand for products like ANGELIQ is likely to grow. Additionally, the focus on using the lowest effective dose of hormone therapy aligns with current medical guidelines, which could further support the adoption of ANGELIQ's lower dose formulation[1].

Market Growth Projections

With the projected increase in pharmaceutical expenditures, ANGELIQ is poised to benefit from the growing demand for hormone therapies. The strategic partnerships and educational initiatives by Bayer Women’s Health will continue to play a crucial role in maintaining and expanding ANGELIQ's market share.

Key Takeaways

• Unique Formulation: ANGELIQ combines estradiol with the progestin drospirenone, making it distinct in the hormone therapy market.
• Market Positioning: ANGELIQ holds a significant position in the competitive hormone therapy market.
• Pricing and Cost Factors: The cost of ANGELIQ varies based on dosage, location, pharmacy, and health insurance.
• Financial Performance: ANGELIQ's financial performance is influenced by broader pharmaceutical expenditure trends.
• Safety and Efficacy: ANGELIQ has been shown to be safe and effective through clinical trials, but carries risks associated with hormone therapy.
• Patient Assistance Programs: Various programs are available to make ANGELIQ more affordable for patients.

FAQs

What is ANGELIQ used for?

ANGELIQ is used to treat moderate to severe vasomotor symptoms and vaginal and vulvar atrophy in postmenopausal women with a uterus.

What are the different formulations of ANGELIQ?

ANGELIQ is available in two formulations: 0.5 mg drospirenone (drsp)/1 mg estradiol (E2) and a lower dose formulation of 0.25 mg drsp/0.5 mg E2.

What are the potential risks associated with ANGELIQ?

ANGELIQ may increase the risk of heart attack, stroke, blood clots, dementia, and certain cancers. It also carries risks such as gallbladder disease, liver problems, and enlargement of benign tumors of the uterus (fibroids)[1].

How much does ANGELIQ cost?

The average retail cost of ANGELIQ is $223.00 per month, but this can vary based on dosage, location, pharmacy, and health insurance. Patient assistance programs can reduce the cost to as low as $80 per month[5].

Are there any patient assistance programs available for ANGELIQ?

Yes, various patient assistance and affordability programs are available to make ANGELIQ more accessible and affordable for patients[5].

Sources

1. U.S. FDA Approves Lower Dose Formulation of ANGELIQ - PR Newswire
2. Oppenheimer NDR_TXMD Final 3 - TherapeuticsMD Inc
3. National trends in prescription drug expenditures and projections for 2024 - PubMed
4. Angeliq - MM+M - Medical Marketing and Media
5. Angeliq Coupon & Assistance Programs - The Rx Advocates