TRIPHASIL-28 Drug Patent Profile

Which patents cover Triphasil-28, and when can generic versions of Triphasil-28 launch?

Triphasil-28 is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in TRIPHASIL-28 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-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	277
DailyMed Link:	TRIPHASIL-28 at DailyMed

Recent Clinical Trials for TRIPHASIL-28

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-28 clinical trials

US Patents and Regulatory Information for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984

International Patents for TRIPHASIL-28

See the table below for patents covering TRIPHASIL-28 around the world.

Country	Patent Number	Title	Estimated Expiration
India	139095	PROCESS FOR PREPARING 13-ETHYLGON-4-ENES
Cyprus	1065	CONTRACEPTIVE METHOD AND PACK
African Intellectual Property Organization (OAPI)	3628
Germany	1793732	VERFAHREN ZUR HERSTELLUNG VON 17(ACYLOXY- ODER ALKOXY)-POLYUNGESAETTIGTEN GONAN- ODER 8-ISOGONANDERIVATEN
United Kingdom	1069846

Supplementary Protection Certificates for TRIPHASIL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

TRIPHASIL-28 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triphasil-28

Introduction

Triphasil-28, a combined oral contraceptive (COC) containing ethinyl estradiol and levonorgestrel, has been a significant player in the contraceptive market. However, its market dynamics and financial trajectory have undergone significant changes over the years.

Historical Context and Approval

Triphasil-28 was approved by the FDA on November 1, 1984, and was initially manufactured by Wyeth Pharmaceuticals Inc.[1].

• The drug was available in a triphasic regimen, consisting of 28 tablets with varying doses of ethinyl estradiol and levonorgestrel across different phases of the cycle[2].

Discontinuation of Brand Name

The brand name Triphasil-28 has been discontinued by its manufacturer. However, this does not mean the end of the product's availability in the market.

• Generic versions of Triphasil-28 continue to be manufactured and marketed by various companies, including Duramed Pharmaceuticals, Novast Labs, Lupin Ltd, Endo Operations, and Dr. Reddy's Labs[1].

Generic Versions and Market Competition

Several generic versions of Triphasil-28 are available, each with the same formulation and dosages:

• Enpresse-28: Approved on July 16, 2001, by Duramed Pharmaceuticals.
• Levonest: Approved on December 29, 2010, by Novast Labs.
• Levonorgestrel and Ethinyl Estradiol: Approved on November 19, 2015, by Lupin Ltd.
• Myzilra: Approved on November 23, 2011, by Endo Operations.
• Trivora-28: Approved on December 18, 1997, by Dr. Reddy's Labs[1].

Regulatory Updates and Warnings

The FDA has updated warnings for combined hormonal contraceptives (CHCs), including Triphasil-28 and its generics.

• These updates include warnings about the increased risk of thromboembolic and thrombotic diseases, cardiovascular risks, and the potential for liver enzyme elevations with certain hepatitis C treatments[2][4].

Market Impact of Regulatory Changes

The updated warnings have had a mixed impact on the market:

• While they may have reduced demand slightly due to increased awareness of potential risks, the overall demand for oral contraceptives remains high.
• The generic market has helped maintain accessibility and affordability for consumers, as generic versions are often cheaper than brand-name products[4].

Financial Trajectory

The financial trajectory of Triphasil-28 and its generics can be analyzed from several angles:

• Revenue Decline for Brand Name: The discontinuation of the brand name Triphasil-28 has led to a decline in revenue for the original manufacturer.
• Generic Market Growth: The availability of multiple generic versions has ensured a steady revenue stream for the generic manufacturers. Generic drugs typically capture a significant market share due to their lower prices, contributing to stable or growing revenues for these companies[1][4].

Pricing and Cost Considerations

The pricing of Triphasil-28 generics is generally lower than that of brand-name contraceptives, making them more accessible to a wider audience.

• This pricing strategy helps in maintaining market share and ensuring continuous revenue flow for the generic manufacturers.
• Additionally, cost savings through generic versions can be significant, which is a key factor in their market success[1].

Consumer Safety and Quality Control

Ensuring the quality and safety of generic drugs is crucial. Regulatory bodies emphasize the importance of quality control throughout the procurement process.

• Manufacturers of generic versions must be prequalified, and tenders should adhere to strict quality standards to ensure the safety and efficacy of the medications[3].

Market Competition and Alternatives

The market for oral contraceptives is highly competitive, with numerous other brands and generics available:

• Other popular brands like Aviane, Vienva, Lutera, and Seasonique compete in the same space, offering similar formulations and benefits.
• The presence of multiple alternatives keeps the market dynamic, with manufacturers continually striving to improve their products and pricing strategies to maintain market share[1].

Future Outlook

The future outlook for Triphasil-28 and its generics remains positive despite the discontinuation of the brand name:

• The continued demand for oral contraceptives, coupled with the availability of affordable generic options, ensures a stable market.
• However, ongoing regulatory updates and safety warnings will continue to influence consumer behavior and market dynamics[4].

Key Takeaways

• Discontinuation of Brand Name: Triphasil-28 is no longer available under its brand name but continues through generic versions.
• Generic Market Dominance: Multiple generic versions ensure affordability and accessibility.
• Regulatory Updates: FDA warnings impact consumer perception but do not significantly reduce demand.
• Financial Stability: Generic manufacturers benefit from stable revenues due to lower pricing.
• Quality Control: Strict quality standards are essential for ensuring consumer safety.

FAQs

Q: What happened to the brand name Triphasil-28? A: The brand name Triphasil-28 has been discontinued by its manufacturer, but generic versions are still available.

Q: Are there any generic versions of Triphasil-28 available? A: Yes, several generic versions are available, including Enpresse-28, Levonest, Levonorgestrel and Ethinyl Estradiol, Myzilra, and Trivora-28.

Q: What are the potential health risks associated with Triphasil-28 and its generics? A: These include increased risks of thromboembolic and thrombotic diseases, cardiovascular risks, and potential liver enzyme elevations with certain hepatitis C treatments.

Q: How do regulatory updates affect the market for Triphasil-28 and its generics? A: Regulatory updates can impact consumer perception but generally do not significantly reduce demand due to the essential nature of the product.

Q: What is the financial outlook for the generic manufacturers of Triphasil-28? A: The financial outlook is stable, with generic manufacturers benefiting from continuous revenue due to the affordability and accessibility of their products.

Cited Sources:

1. Generic Triphasil-28 Availability - Drugs.com
2. Triphasil®-28 - Pfizer
3. Options for Contraceptive Procurement: Lessons Learned from Latin America - Health Policy Plus
4. FDA Updates Warnings for Combined Hormonal Contraceptives - Managed Healthcare Executive