ESTROSTEP 21 Drug Patent Profile

When do Estrostep 21 patents expire, and what generic alternatives are available?

Estrostep 21 is a drug marketed by Apil and is included in one NDA.

The generic ingredient in ESTROSTEP 21 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for ESTROSTEP 21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	130
DailyMed Link:	ESTROSTEP 21 at DailyMed

US Patents and Regulatory Information for ESTROSTEP 21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	No

Expired US Patents for ESTROSTEP 21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	4,962,098
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	5,010,070

International Patents for ESTROSTEP 21

See the table below for patents covering ESTROSTEP 21 around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203142	CONTRACEPTIVOS DE ESTROGENOS TITULADOS.

Supplementary Protection Certificates for ESTROSTEP 21

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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

ESTROSTEP 21 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESTROSTEP 21

Introduction

ESTROSTEP 21, an oral contraceptive, has been a part of the contraceptive market since its approval in 1996. This article will delve into the market dynamics and financial trajectory of ESTROSTEP 21, including its approval, usage, and market position.

Approval and Indications

ESTROSTEP 21 was approved by the FDA on October 9, 1996, for the prevention of pregnancy in women who elect to use oral contraceptives. It was later approved for the treatment of moderate acne vulgaris on July 1, 2001[3].

Dosage Regimen

ESTROSTEP 21 is a graduated estrophasic combined oral contraceptive, providing estrogen in a gradually increasing sequence over a 21-day period with a constant dose of progestogen. The regimen consists of 21 oral contraceptive tablets with varying doses of ethinyl estradiol and norethindrone acetate[1].

Market Position

ESTROSTEP 21 was initially marketed alongside its variant, ESTROSTEP FE, which includes seven additional ferrous fumarate tablets to facilitate a 28-day regimen. However, ESTROSTEP 21 was never commercially marketed in the United States, unlike ESTROSTEP FE[3].

Safety and Efficacy

The FDA determined that ESTROSTEP 21 was not withdrawn from sale for reasons of safety or effectiveness. This determination was based on the absence of any data or reports indicating safety or efficacy concerns. The same therapeutic dosage regimen is used in ESTROSTEP FE, which continues to be marketed[3].

Clinical Trials and Efficacy Data

While specific clinical trial data for ESTROSTEP 21 is not readily available, its efficacy and safety profile are inferred from studies on ESTROSTEP FE. These studies showed statistically significant reductions in acne lesions and overall treatment success in the investigator’s global evaluation[1].

Competitive Landscape

The oral contraceptive market is highly competitive, with various formulations and brands available. The introduction of new estrogen components like estradiol valerate and estetrol has expanded the options for women, potentially affecting the market share of traditional ethinyl estradiol-containing pills like ESTROSTEP 21[4].

Financial Trajectory

Given that ESTROSTEP 21 was never commercially marketed, it did not generate any revenue. The financial trajectory of this product is essentially non-existent in terms of sales and market impact. The focus has been on its variant, ESTROSTEP FE, which continues to be a part of the contraceptive market.

Regulatory Impact

The FDA's determination that ESTROSTEP 21 was not withdrawn for safety or effectiveness reasons allows for the approval of abbreviated new drug applications (ANDAs) for similar combination drugs. This regulatory stance ensures that generic versions of similar oral contraceptives can enter the market, potentially affecting the pricing and availability of branded products like ESTROSTEP FE[3].

Consumer Impact

For consumers, the absence of ESTROSTEP 21 from the market means they have to opt for other available oral contraceptives, including ESTROSTEP FE. The gradual increase in estrogen dose and constant progestogen dose in ESTROSTEP FE provide a similar therapeutic regimen, making it a viable alternative[1].

Future Prospects

The future prospects for ESTROSTEP 21 are limited since it was never commercially available. However, the ongoing development and approval of new oral contraceptives with different estrogen components may influence the market dynamics of existing products like ESTROSTEP FE.

Key Takeaways

• Approval and Indications: Approved for pregnancy prevention and acne treatment but never commercially marketed.
• Dosage Regimen: Gradually increasing estrogen dose with constant progestogen.
• Market Position: Not commercially available; ESTROSTEP FE is the marketed variant.
• Safety and Efficacy: Determined safe and effective by FDA.
• Competitive Landscape: Part of a competitive oral contraceptive market with new formulations emerging.
• Financial Trajectory: No revenue generated due to lack of commercial marketing.

FAQs

Q: What is the dosage regimen of ESTROSTEP 21? A: ESTROSTEP 21 consists of 21 oral contraceptive tablets with a gradually increasing dose of ethinyl estradiol and a constant dose of norethindrone acetate.

Q: Why was ESTROSTEP 21 not commercially marketed? A: ESTROSTEP 21 was never commercially marketed in the United States, although it was approved by the FDA.

Q: Is ESTROSTEP 21 safe and effective? A: Yes, the FDA determined that ESTROSTEP 21 was not withdrawn from sale for reasons of safety or effectiveness.

Q: What is the difference between ESTROSTEP 21 and ESTROSTEP FE? A: ESTROSTEP FE includes seven additional ferrous fumarate tablets to facilitate a 28-day regimen, while ESTROSTEP 21 does not.

Q: How does the market position of ESTROSTEP 21 compare to other oral contraceptives? A: ESTROSTEP 21 is not commercially available, making it irrelevant in current market dynamics, while other oral contraceptives, including new formulations, are actively marketed.

Cited Sources

1. ESTROSTEP Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets) Label - FDA.
2. Lo Loestrin Fe NDA 22-501 - FDA.
3. Federal Register/Vol. 72, No. 99/Wednesday, May 23, 2007/Notices - GovInfo.
4. Update on current contraceptive options: A case-based discussion - Cleveland Clinic Journal of Medicine.