TRI-NORINYL 21-DAY Drug Patent Profile

When do Tri-norinyl 21-day patents expire, and when can generic versions of Tri-norinyl 21-day launch?

Tri-norinyl 21-day is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

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

Summary for TRI-NORINYL 21-DAY

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Patent Applications:	131
DailyMed Link:	TRI-NORINYL 21-DAY at DailyMed

US Patents and Regulatory Information for TRI-NORINYL 21-DAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984		DISCN	No	No

Expired US Patents for TRI-NORINYL 21-DAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dr Reddys Labs Sa	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984	4,390,531

International Patents for TRI-NORINYL 21-DAY

See the table below for patents covering TRI-NORINYL 21-DAY around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3229612
Australia	560922
Malaysia	8700596	METHOD OF CONTRACEPTION AND PHARMACEUTICAL PACKAGE THEREFOR
Canada	1198057	METHODE DE CONTRACEPTION PAR ADMINISTRATION DE PROGESTOGENE (METHOD OF CONTRACEPTION USING PEAK PROGESTOGEN DOSAGE)
United Kingdom	2104779	METHOD OF CONTRACEPTION AND PHARMACEUTICAL PACKAGE THEREFOR
Singapore	93686
Hong Kong	26087	METHOD OF CONTRACEPTION AND PHARMACEUTICAL PACKAGE THEREFOR

Supplementary Protection Certificates for TRI-NORINYL 21-DAY

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

TRI-NORINYL 21-DAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TRI-NORINYL 21-DAY

Introduction

TRI-NORINYL 21-DAY, a combination oral contraceptive, has been a part of the pharmaceutical market for several years, although the brand name has been discontinued in the U.S. This article delves into the market dynamics and financial trajectory of this drug, exploring its history, usage, and the impact of its discontinuation.

Product Overview

TRI-NORINYL 21-DAY is a continuous oral contraceptive regimen consisting of 7 blue tablets, 9 yellow-green tablets, and 5 more blue tablets, followed by 7 inert orange tablets. Each active tablet contains a combination of norethindrone and ethinyl estradiol, which act to suppress gonadotrophins, inhibit ovulation, and alter cervical mucus and the endometrium to prevent pregnancy[1].

Market History

The drug was initially marketed under the brand name TRI-NORINYL, but it has since been discontinued in the U.S. However, generic versions of this product may still be available, approved by the FDA. This transition from a branded to a generic product has significant implications for market dynamics and financial performance.

Generic Equivalents and Competition

The discontinuation of the branded version has led to the availability of generic equivalents. Generic drugs, such as those AB-rated to TRI-NORINYL, are manufactured by various companies, including Teva Pharmaceutical Industries Ltd. and others. These generics compete directly with any remaining branded versions and other generic products in the market[2].

Pricing Dynamics

The introduction of generic equivalents significantly impacts pricing. Authorized generic drugs, which are brand-name drugs marketed as generics, can lower retail and wholesale prices. Studies have shown that during the 180-day exclusivity period, competition from authorized generics can reduce retail generic prices by 4-8% and wholesale prices by 7-14% compared to prices without such competition[4].

Financial Impact on Manufacturers

The presence of generic competition, especially from authorized generics, can substantially reduce the revenues of both brand-name and first-filer generic manufacturers. During the 180-day exclusivity period, the first-filer generic’s revenues can be reduced by 40-52%. This impact persists even after the exclusivity period, with revenues 53-62% lower in the following 30 months[4].

Consumer Impact

For consumers, the availability of generic versions of TRI-NORINYL 21-DAY can lead to cost savings. Generic drugs are generally cheaper than their branded counterparts, making oral contraceptives more accessible to a wider population. This is particularly significant given the high efficacy of oral contraceptives, with accidental pregnancy rates as low as 0.3-0.5% for non-smokers using these methods correctly[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. The FDA’s approval process for generics ensures that these products meet the same safety and efficacy standards as their branded counterparts. Additionally, regulatory actions, such as those by the Federal Trade Commission (FTC), can influence competition by preventing anti-competitive practices and ensuring that mergers and acquisitions do not reduce competition in the pharmaceutical market[2][4].

Market Share and Sales

The discontinuation of the branded TRI-NORINYL and the introduction of generic equivalents have likely shifted market share. Generic drugs tend to capture a significant portion of the market due to their lower prices. This shift can lead to a reduction in sales for the original brand, while generic manufacturers may see an increase in their market share and sales volume.

Clinical and Economic Outcomes

From a clinical perspective, the efficacy of TRI-NORINYL 21-DAY and its generic equivalents remains high. However, economic outcomes are influenced by the cost of treatment. Studies have shown that the implementation of formulary changes and the use of generic drugs can lead to a reduction in the cost per day of treatment, benefiting both patients and healthcare systems[5].

Future Outlook

The future outlook for TRI-NORINYL 21-DAY and its generic equivalents is shaped by ongoing market competition and regulatory changes. As more generic versions enter the market, prices are likely to remain competitive, benefiting consumers. However, the financial trajectory for manufacturers will depend on their ability to adapt to these market changes and maintain market share.

Key Takeaways

• Discontinuation of Branded Version: The brand name TRI-NORINYL has been discontinued, but generic versions remain available.
• Generic Competition: Generic equivalents compete directly with other generics, affecting pricing and market share.
• Pricing Impact: Authorized generics can lower retail and wholesale prices significantly.
• Financial Impact: Generic competition reduces revenues for both brand-name and first-filer generic manufacturers.
• Consumer Benefits: Generic versions make oral contraceptives more accessible and affordable.
• Regulatory Influence: FDA and FTC actions shape the competitive landscape.

FAQs

Q: What is TRI-NORINYL 21-DAY used for?

A: TRI-NORINYL 21-DAY is used for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Q: Why was the brand name TRI-NORINYL discontinued?

A: The brand name TRI-NORINYL has been discontinued in the U.S., but generic versions of this product may still be available.

Q: How do generic versions affect the market?

A: Generic versions, especially authorized generics, can lower prices and reduce the revenues of brand-name and first-filer generic manufacturers.

Q: What is the clinical efficacy of TRI-NORINYL 21-DAY?

A: The drug is highly effective, with accidental pregnancy rates as low as 0.3-0.5% for non-smokers using the method correctly.

Q: How does the regulatory environment impact the market for TRI-NORINYL 21-DAY?

A: Regulatory actions by the FDA and FTC ensure that generics meet safety and efficacy standards and prevent anti-competitive practices, influencing market competition.

Sources

1. Drugs.com: Tri-Norinyl: Package Insert / Prescribing Information.
2. Federal Trade Commission: Federal Register/Vol. 81, No. 151/Friday, August 5, 2016/Notices.
3. eMPR.com: TRI-NORINYL 28 Prescription & Dosage Information.
4. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
5. Health.mil: DECISION PAPER - Health.mil.