DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - Generic Drug Details

What are the generic sources for drospirenone; ethinyl estradiol; levomefolate calcium and what is the scope of patent protection?

Drospirenone; ethinyl estradiol; levomefolate calcium is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Lupin Ltd, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

US Patents:	2
Tradenames:	4
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
DailyMed Link:	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM at DailyMed

Recent Clinical Trials for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

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

Sponsor	Phase
Bayer	Phase 3

See all DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEYAZ	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.02 mg/ 0.451 mg and 0.451 mg	022532	1	2012-11-13
SAFYRAL	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.03 mg/ 0.451 mg and 0.451 mg	022574	1	2012-09-28

US Patents and Regulatory Information for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	8,617,597		Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes	11,617,751		Y
Watson Labs Inc	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	203593-001	Oct 11, 2016	AB	RX	No	No
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	11,617,751		Y
Lupin Ltd	TYDEMY	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205948-001	Dec 12, 2017	AB	RX	No	No
Lupin Ltd	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947-001	Jun 13, 2018	AB	RX	No	No

Expired US Patents for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	7,163,931
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,441,168
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE37564
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	5,798,338
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE38253
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE37838

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Drospirenone; Ethinyl Estradiol; Levomefolate Calcium

Introduction

Drospirenone; ethinyl estradiol; levomefolate calcium, marketed under the brand name Beyaz, is a unique oral contraceptive that combines the benefits of hormonal contraception with folate supplementation. Approved in 2010, this drug has carved a niche in the market by addressing multiple health needs of women, including contraception, premenstrual dysphoric disorder (PMDD), acne, and folate supplementation.

Market Need and Target Audience

The market for oral contraceptives is substantial, driven by the need for effective birth control methods. Beyaz targets women of childbearing age, particularly those who require contraception and may also benefit from the treatment of PMDD and moderate acne. The inclusion of levomefolate calcium, a metabolite of folic acid, adds an additional layer of benefit by reducing the risk of neural tube defects, a critical consideration for women planning to conceive in the future[1][4][5].

Competitive Landscape

Beyaz is part of the broader market of combination oral contraceptives but stands out due to its unique formulation that includes levomefolate calcium. This differentiation allows it to compete effectively against other oral contraceptives that do not offer folate supplementation. The drug's efficacy in treating PMDD and acne also positions it favorably against other treatments that may only address one or two of these conditions[1][4].

Regulatory Environment

The approval of Beyaz by the FDA in 2010 marked a significant milestone. The regulatory environment for oral contraceptives is stringent, with a focus on safety, efficacy, and the potential for adverse reactions. Beyaz has undergone rigorous clinical trials to establish its safety and efficacy profile, which includes the risk of venous and arterial thrombotic and thromboembolic events, among other potential side effects[1][3].

Clinical Efficacy and Safety

Clinical trials have demonstrated that Beyaz is effective as an oral contraceptive, with a pregnancy rate (Pearl Index) of 1.41 per 100 woman-years of use. It also shows statistically significant improvements in symptoms of PMDD and moderate acne compared to placebo. The addition of levomefolate calcium significantly increases folate levels in women, which is crucial for preventing neural tube defects[1][4].

Side Effects and Contraindications

While Beyaz offers several benefits, it is not without risks. Common adverse reactions include headache/migraine, menstrual irregularities, nausea/vomiting, and breast pain/tenderness. More serious risks include venous and arterial thrombotic and thromboembolic events, particularly in the first year of use and in women over 35 years old who smoke. It is contraindicated in women with certain health conditions such as renal impairment, adrenal insufficiency, or those predisposed to hyperkalemia[1].

Financial Performance

The financial trajectory of Beyaz is influenced by several factors, including market demand, competition, and pricing strategies. As a branded product, Beyaz benefits from its unique formulation and the trust associated with the Bayer HealthCare Pharmaceuticals brand. However, the presence of generic alternatives and other oral contraceptives can impact its market share and revenue.

Market Trends and Projections

The market for oral contraceptives is expected to grow, driven by increasing awareness of reproductive health and the need for effective birth control methods. Beyaz, with its multifaceted benefits, is well-positioned to capture a significant share of this market. However, the pharmaceutical industry is highly competitive, and continuous innovation and marketing efforts are necessary to maintain market position.

Pricing and Reimbursement

The pricing of Beyaz is a critical factor in its market dynamics. The drug is generally covered by health insurance plans, which helps in making it more accessible to a wider audience. However, out-of-pocket costs and copayments can vary, influencing patient adherence and provider prescribing habits.

Patient Adherence and Compliance

Patient adherence to Beyaz is crucial for its effectiveness. Factors such as ease of use, side effect profile, and patient education play significant roles in ensuring compliance. Healthcare providers often emphasize the importance of consistent use to maximize the benefits of the medication.

Industry Expert Insights

Industry experts highlight the importance of counseling women on the benefits and risks of Beyaz. As noted by experts, "physician time is better spent counseling women, regardless of contraceptive choice, on the importance of folic acid supplementation during the child-bearing years"[4].

Future Outlook

The future outlook for Beyaz is promising, given its unique benefits and the ongoing need for effective oral contraceptives. Continuous monitoring of safety and efficacy, along with educational efforts to promote awareness and adherence, will be key to maintaining its market position.

Key Takeaways

• Unique Formulation: Beyaz combines hormonal contraception with folate supplementation, addressing multiple health needs.
• Clinical Efficacy: Effective in preventing pregnancy, treating PMDD, and moderate acne.
• Safety Profile: Associated with risks such as thrombotic and thromboembolic events, particularly in certain demographic groups.
• Market Position: Well-positioned in the oral contraceptive market due to its multifaceted benefits.
• Financial Trajectory: Influenced by market demand, competition, and pricing strategies.
• Future Outlook: Promising, with a focus on continuous safety monitoring and patient education.

FAQs

Q: What are the primary uses of Drospirenone; Ethinyl Estradiol; Levomefolate Calcium? A: It is used to prevent ovulation and pregnancy, treat symptoms of PMDD, treat moderate acne, and raise folate levels in women.

Q: What is the unique component of Beyaz compared to other oral contraceptives? A: The inclusion of levomefolate calcium, which helps in reducing the risk of neural tube defects.

Q: What are the common side effects of Beyaz? A: Common side effects include headache/migraine, menstrual irregularities, nausea/vomiting, and breast pain/tenderness.

Q: Who should avoid using Beyaz? A: Women over 35 years old who smoke, those with renal impairment, adrenal insufficiency, or predisposed to hyperkalemia should avoid using Beyaz.

Q: Is Beyaz covered by health insurance plans? A: Yes, Beyaz is generally covered by health insurance plans, although out-of-pocket costs and copayments may vary.

Sources

1. Managed Healthcare Executive: "Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz)"
2. FDA: "Drospirenone; Ethinyl Estradiol; Levomefolate Calcium"
3. FDA: "Drospirenone; Ethinyl Estradiol; Levomefolate Calcium Oral Tablet"
4. PubMed: "The combined oral contraceptive pill containing drospirenone and ethinyl estradiol plus levomefolate calcium"
5. Cleveland Clinic: "Drospirenone; Ethinyl Estradiol; Levomefolate Tablets"