Ethinyl estradiol; norethindrone acetate - Generic Drug Details

What are the generic drug sources for ethinyl estradiol; norethindrone acetate and what is the scope of patent protection?

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-nine branded drugs marketed by Xiromed, Wilshire Pharms Inc, Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apil, Millicent Pr, Aurobindo Pharma, Lupin Ltd, Teva Pharms Usa Inc, Endo Operations, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Apotex, Glenmark Speclt, Barr, and Parke Davis, and is included in seventy-four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has nine patent family members in seven countries.

Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ethinyl estradiol; norethindrone acetate

International Patents:	9
US Patents:	1
Tradenames:	59
Applicants:	19
NDAs:	74
Finished Product Suppliers / Packagers:	27
Clinical Trials:	13
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; norethindrone acetate
DailyMed Link:	ethinyl estradiol; norethindrone acetate at DailyMed

Recent Clinical Trials for ethinyl estradiol; norethindrone acetate

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

Sponsor	Phase
University of Virginia	Early Phase 1
Ironwood Pharmaceuticals, Inc.	Phase 1
National Institutes of Health (NIH)	Phase 3

See all ethinyl estradiol; norethindrone acetate clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Applicant	Application No.	Strength	Dosage Form
		0.01MG,0.01MG;1MG,N/A	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ethinyl estradiol; norethindrone acetate

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; norethindrone acetate

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 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LO LOESTRIN FE	Tablets	ethinyl estradiol; norethindrone acetate	1 mg/0.01 mg, 0.01 mg and 75 mg	022501	1	2011-04-29

US Patents and Regulatory Information for ethinyl estradiol; norethindrone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	FYAVOLV	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	204213-001	Dec 10, 2015	AB	RX	No	No
Barr	JUNEL FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	076064-001	Sep 18, 2003	AB	RX	No	Yes
Novast Labs	CHABELINA FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	202962-001	Apr 15, 2020	AB	RX	No	Yes
Glenmark Speclt	HAILEY FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	209031-001	Jun 5, 2018	AB	RX	No	No
Lupin Ltd	FYAVOLV	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	204213-002	Dec 10, 2015	AB	RX	No	No
Dr Reddys Labs Sa	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	213901-001	Apr 28, 2022		DISCN	No	No

Expired US Patents for ethinyl estradiol; norethindrone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	MINASTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203667-001	May 8, 2013	6,667,050
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	5,010,070
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005	5,208,225
Apil	MINASTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203667-001	May 8, 2013	5,552,394
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	5,552,394
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	5,552,394

International Patents for ethinyl estradiol; norethindrone acetate

Country	Patent Number	Title	Estimated Expiration
China	104248639	Extended estrogen dosing contraceptive regimen
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
China	101189015	Extended estrogen dosing contraceptive regimen

Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

Ethinyl estradiol; norethindrone acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol; Norethindrone Acetate

Introduction

Ethinyl estradiol and norethindrone acetate are widely used in combination products for routine contraception and hormone replacement therapy (HRT). Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for ethinyl estradiol and norethindrone acetate is driven by the demand for effective contraceptive methods and HRT solutions. These combination products are among the most commonly prescribed hormonal contraceptives and are used by women from the time of menarche to menopause, provided there are no contraindications[4].

Demand Drivers

• Contraceptive Needs: The global demand for effective and reliable contraceptive methods continues to drive the market. Ethinyl estradiol and norethindrone acetate combination products are popular due to their high efficacy in preventing pregnancy.
• Hormone Replacement Therapy: The increasing number of women entering menopause and seeking HRT to manage symptoms such as hot flashes, vaginal dryness, and osteoporosis also contributes to the demand.
• Regulatory Approvals: Continuous regulatory approvals and updates in prescribing information help maintain market presence and adapt to changing healthcare needs[2][4].

Competitive Landscape

The market for ethinyl estradiol and norethindrone acetate is competitive, with several pharmaceutical companies offering similar products. Key players include major pharmaceutical firms that have established brands and generic manufacturers that offer more affordable alternatives.

Product Variations and Dosing

• Dosage Forms: These combination products are available in various dosages, such as norethindrone acetate 0.5 mg with ethinyl estradiol 2.5 mcg or norethindrone acetate 1 mg with ethinyl estradiol 5 mcg, allowing for tailored treatment plans[4].
• Regimens: Different regimens, including 24-day cycles with ferrous fumarate, are designed to enhance compliance and reduce the risk of thromboembolic events[2].

Safety and Efficacy Concerns

• Thromboembolic Risks: One of the significant concerns is the increased risk of thromboembolic disorders, such as deep venous thrombosis (DVT) and stroke. This has led to specific guidelines for use, especially around surgeries and postpartum periods[2][5].
• Breast Health: Adverse reactions including breast tenderness, nipple pain, and changes in breast tissue are common. These side effects can impact patient compliance and overall market perception[4].

Financial Performance

The financial performance of ethinyl estradiol and norethindrone acetate combination products is influenced by several factors:

• Sales Volume: High demand for these products, particularly in the contraceptive market, contributes to significant sales volumes.
• Pricing Strategies: The presence of both branded and generic versions allows for a range of pricing strategies, affecting revenue and market share.
• Research and Development: Continuous investment in research to improve formulations, reduce side effects, and enhance efficacy helps maintain market competitiveness.

Market Trends

• Generic Competition: The entry of generic versions of these combination products has increased competition, potentially reducing the market share of branded products.
• Advancements in Formulations: Ongoing research into new formulations and delivery methods (e.g., patches, rings) may shift market dynamics and consumer preferences.
• Regulatory Changes: Changes in regulatory guidelines and safety warnings can impact prescribing practices and consumer confidence.

Geographical Market Analysis

The market for ethinyl estradiol and norethindrone acetate varies geographically due to differences in healthcare systems, regulatory environments, and cultural attitudes towards contraception and HRT.

• Developed Markets: In countries like the United States and those in Europe, there is a well-established market with a high demand for these products.
• Emerging Markets: In regions with growing populations and increasing access to healthcare, the demand for contraceptive and HRT solutions is on the rise.

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics:

• Awareness and Education: Increased awareness about the benefits and risks of hormonal contraceptives and HRT influences consumer choices.
• Side Effect Tolerance: Consumers are becoming more discerning about the side effects of these products, driving demand for formulations with fewer adverse reactions.

Healthcare Provider Influence

Healthcare providers significantly influence the market through their prescribing practices:

• Guidelines and Recommendations: Adherence to clinical guidelines and recommendations from professional organizations affects the prescription rates of these products.
• Patient Counseling: Effective patient counseling on the benefits and risks of ethinyl estradiol and norethindrone acetate combination products can impact patient compliance and market performance.

Economic Impact

The economic impact of these products is substantial:

• Revenue Generation: These products generate significant revenue for pharmaceutical companies.
• Healthcare Costs: The use of these products can reduce healthcare costs in the long term by preventing unintended pregnancies and managing menopausal symptoms effectively.

Future Outlook

The future outlook for ethinyl estradiol and norethindrone acetate combination products is promising but challenging:

• Innovative Formulations: The development of new formulations with improved safety profiles and efficacy will be crucial.
• Regulatory Environment: Changes in regulatory requirements and safety guidelines will continue to shape the market.
• Consumer Preferences: Evolving consumer preferences and increased awareness about health and wellness will drive market trends.

Key Takeaways

• Ethinyl estradiol and norethindrone acetate combination products are widely used for contraception and HRT.
• The market is driven by demand for effective and safe hormonal treatments.
• Safety concerns, particularly regarding thromboembolic risks, are critical factors.
• Regulatory changes, generic competition, and consumer preferences influence market dynamics.
• Continuous innovation in formulations and delivery methods is essential for maintaining market competitiveness.

Frequently Asked Questions (FAQs)

Q: What are the common uses of ethinyl estradiol and norethindrone acetate combination products? A: These products are commonly used for routine contraception and hormone replacement therapy (HRT).

Q: What are the potential side effects of ethinyl estradiol and norethindrone acetate? A: Common side effects include breast tenderness, vaginal candidiasis, and fluid retention. Serious side effects can include thromboembolic disorders and increased risk of stroke[2][4].

Q: How do generic versions impact the market for these products? A: Generic versions increase competition, potentially reducing the market share of branded products but also making these treatments more affordable for consumers.

Q: What are the key factors influencing the financial performance of these products? A: Sales volume, pricing strategies, research and development investments, and regulatory changes are key factors influencing financial performance.

Q: What is the future outlook for ethinyl estradiol and norethindrone acetate combination products? A: The future outlook is promising, with a focus on innovative formulations, adherence to evolving regulatory requirements, and adapting to changing consumer preferences.

Cited Sources:

1. Formation of Ethinyl Estradiol in Women during Treatment with Norethindrone Acetate - Journal of Clinical Endocrinology and Metabolism[1].
2. Norethindrone, Ethinyl Estradiol and Ferrous Fumarate - Drugs.com[2].
3. Formation of Ethinyl Estradiol in Women during Treatment with Norethindrone Acetate - PubMed[3].
4. Ethinyl Estradiol; Norethindrone Acetate - Elsevier Healthcare Hub[4].
5. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL tablet - DailyMed[5].