TRIPHASIL-21 Drug Patent Profile

When do Triphasil-21 patents expire, and when can generic versions of Triphasil-21 launch?

Triphasil-21 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in TRIPHASIL-21 is ethinyl estradiol; levonorgestrel. 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; levonorgestrel profile page.

Summary for TRIPHASIL-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	277
DailyMed Link:	TRIPHASIL-21 at DailyMed

Recent Clinical Trials for TRIPHASIL-21

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

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all TRIPHASIL-21 clinical trials

US Patents and Regulatory Information for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984

International Patents for TRIPHASIL-21

See the table below for patents covering TRIPHASIL-21 around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	47080	CONTRACEPTIVE METHOD AND PACK
Austria	281313
Philippines	11433	SYNTHESIS OF 13-POLYCARBONALKYL GONA-2,5(10)-DIEN-17-OLS
Netherlands	146502
United Kingdom	1041273

Supplementary Protection Certificates for TRIPHASIL-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

TRIPHASIL-21 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triphasil-21

Introduction

Triphasil-21, a combined oral contraceptive (COC) developed by Pfizer, has been a significant player in the contraceptive market. However, its market dynamics and financial trajectory have been influenced by various factors, including regulatory updates, competitive landscape, and consumer preferences.

Product Overview

Triphasil-21 is a triphasic regimen consisting of 21 tablets, divided into three phases with varying doses of levonorgestrel and ethinyl estradiol. This formulation is designed to provide effective contraception while minimizing side effects[2][5].

Regulatory Environment

The FDA has played a crucial role in shaping the market dynamics of Triphasil-21. Recent updates to the labeling of combined hormonal contraceptives (CHCs) include warnings about a small increased risk of breast cancer among current or recent users and those with longer duration of use. Despite these updates, epidemiology studies have not found a consistent association between COC use and breast cancer risk[4].

Contraindications and Warnings

Triphasil-21 is contraindicated in women with current or past breast cancer, as well as those with certain other conditions such as liver tumors, thromboembolic disorders, and hereditary angioedema. These contraindications can impact the drug's market reach and financial performance[1][5].

Dosage and Administration

The specific dosage regimen of Triphasil-21, which involves a 21-day cycle followed by a 7-day break, can influence patient compliance and satisfaction. Proper administration is crucial for maximum contraceptive effectiveness, and any deviations can lead to reduced efficacy and increased risk of breakthrough bleeding[2][5].

Market Competition

The contraceptive market is highly competitive, with various oral contraceptives, implants, injections, and intrauterine devices (IUDs) available. Triphasil-21 competes with other COCs, as well as non-hormonal methods, which can affect its market share and financial performance. The discontinuation of the Triphasil brand by Pfizer has further impacted its market presence[4].

Financial Impact of Regulatory Changes

The updated FDA warnings and contraindications have likely influenced the financial trajectory of Triphasil-21. Increased caution among healthcare providers and patients may have led to a decline in prescriptions, affecting revenue. Additionally, the costs associated with updating labeling and ensuring compliance with new regulatory requirements can be significant[4].

Consumer Preferences and Compliance

Consumer preferences for contraception are diverse and can be influenced by factors such as ease of use, side effects, and effectiveness. Triphasil-21's triphasic regimen may appeal to some users due to its tailored hormonal doses, but it may also be less convenient for others compared to simpler regimens or non-daily methods. Compliance issues, such as missing doses or starting the cycle late, can reduce the drug's effectiveness and impact its market performance[2][5].

Procurement and Access

In regions where contraceptive procurement is a significant concern, the availability and affordability of Triphasil-21 can be critical. Institutions and healthcare systems need to accurately forecast contraceptive needs and financial requirements to ensure access to these medications. However, the discontinuation of the brand may complicate procurement processes[3].

Discontinuation of the Brand

Pfizer's decision to discontinue the Triphasil brand has had a profound impact on its market dynamics and financial trajectory. This move has likely led to a decline in sales and revenue, as well as a shift in market share to other available contraceptives. Generic versions may still be available, but the loss of brand recognition and support can be detrimental[4].

Long-Term Health Benefits

Despite the challenges, Triphasil-21 has been associated with several long-term health benefits, including reduced incidence of ovarian and endometrial cancers, fibroadenomas, and acute pelvic inflammatory disease. These benefits can maintain patient loyalty and healthcare provider recommendations, although they may not fully offset the financial impact of regulatory changes and brand discontinuation[1].

Key Takeaways

• Regulatory Updates: Recent FDA warnings and contraindications have impacted the market dynamics and financial performance of Triphasil-21.
• Market Competition: The contraceptive market is highly competitive, and Triphasil-21 faces challenges from other COCs and non-hormonal methods.
• Consumer Preferences: Compliance and ease of use are crucial for the drug's effectiveness and market appeal.
• Discontinuation of the Brand: Pfizer's decision to discontinue Triphasil has significantly affected its market presence and financial trajectory.
• Long-Term Health Benefits: Despite challenges, the drug offers several long-term health benefits that can influence patient and healthcare provider decisions.

FAQs

Q: What is the dosage regimen for Triphasil-21? A: Triphasil-21 involves taking one tablet daily for 21 consecutive days, divided into three phases: 6 brown tablets, 5 white tablets, and 10 light-yellow tablets, followed by a 7-day break[2][5].

Q: What are the contraindications for Triphasil-21? A: Triphasil-21 is contraindicated in women with current or past breast cancer, liver tumors, thromboembolic disorders, and hereditary angioedema, among other conditions[1][5].

Q: How has the FDA's updated labeling affected Triphasil-21? A: The FDA's updated labeling includes warnings about a small increased risk of breast cancer among current or recent users and those with longer duration of use, which may have impacted prescriptions and revenue[4].

Q: Why was the Triphasil brand discontinued by Pfizer? A: The specific reasons for Pfizer's decision to discontinue the Triphasil brand are not detailed, but it has significantly impacted the drug's market presence and financial trajectory[4].

Q: What are the long-term health benefits associated with Triphasil-21? A: Triphasil-21 is associated with reduced incidence of ovarian and endometrial cancers, fibroadenomas, and acute pelvic inflammatory disease, among other benefits[1].

Sources

1. FDA Labeling for Triphasil-21: accessdata.fda.gov
2. Triphasil Dosage Guide: Drugs.com
3. Options for Contraceptive Procurement: healthpolicyplus.com
4. FDA Updates Warnings for Combined Hormonal Contraceptives: Managed Healthcare Executive
5. Triphasil-21 Tablets Labeling: Pfizer