TAYTULLA Drug Patent Profile

When do Taytulla patents expire, and when can generic versions of Taytulla launch?

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

The generic ingredient in TAYTULLA 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 TAYTULLA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	130
Drug Prices:	Drug price information for TAYTULLA
Drug Sales Revenues:	Drug sales revenues for TAYTULLA
What excipients (inactive ingredients) are in TAYTULLA?	TAYTULLA excipients list
DailyMed Link:	TAYTULLA at DailyMed

See drug prices for TAYTULLA

See drug sales revenues for TAYTULLA

US Patents and Regulatory Information for TAYTULLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	AB	RX	Yes	Yes

Expired US Patents for TAYTULLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	5,552,394
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	6,652,880

International Patents for TAYTULLA

See the table below for patents covering TAYTULLA around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	0009373
Hungary	227155	ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING TRIGLYCERIDES OF LONG-CHAIN FATTY ACIDS AND LIPOPHILIC SURFACTANTS
European Patent Office	1173153	COMPOSITIONS PHARMACEUTIQUES ORALES RENFERMANT DES TRIGLYCERIDES A LONGUE CHAINE ET DES TENSIOACTIFS LIPOPHILES (ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING LONG-CHAIN TRIGLYCERIDES AND LIPOPHILIC SURFACTANTS)
Mexico	PA01009817	COMPOSICIONES FARMACEUTICAS ORALES LAS CUALES CONTIENEN TRIGLICERIDOS DE CADENA LARGA Y TENSIOACTIVOS LIPOFILICOS. (ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING LONG-CHAIN TRIGLYCERIDES AND LIPOPHILIC SURFACTANTS.)
Hong Kong	1040364
Poland	196823

Supplementary Protection Certificates for TAYTULLA

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

TAYTULLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TAYTULLA

Introduction

TAYTULLA, a combined oral contraceptive (COC) developed by Allergan Pharmaceuticals, is a significant player in the contraceptive drugs market. This article delves into the market dynamics and financial trajectory of TAYTULLA, highlighting key factors influencing its market position and financial performance.

Market Overview of Contraceptive Drugs

The contraceptive drugs market is driven by several key factors, including the need to prevent unintended pregnancies, increasing awareness about contraceptive pills, and government and NGO initiatives to promote family planning[1][4].

Demand and Market Size

The global contraceptive drugs market is expected to reach USD 20.3 billion by 2030, growing at a CAGR of 7.1%. This growth is fueled by increasing global understanding and acceptance of family planning, supportive legal frameworks, and advancements in contraceptive formulation technology[4].

TAYTULLA's Market Position

TAYTULLA, a generic version of Allergan's original formulation, has a notable presence in the US market. According to IQVIA MAT data for February 2022, TAYTULLA generated approximately USD 90 million in annual sales in the US. This figure indicates a substantial market share for the drug[1][4].

Competitive Landscape

The contraceptive drugs market is competitive, with various pharmaceutical companies introducing new and generic versions of contraceptive medications. For instance, Lupin Pharma launched Merzee capsules, a generic version of TAYTULLA, through an exclusivity agreement with Slayback Pharma LLC. This competition can impact the market share and pricing of TAYTULLA[1][4].

Government and NGO Initiatives

Government regulations and NGO initiatives play a crucial role in the market dynamics of contraceptive drugs. Supportive legal frameworks and awareness campaigns make contraceptive medications more accessible and affordable, particularly in underdeveloped countries. These efforts can enhance the demand for TAYTULLA and similar contraceptives[4].

Technological Advancements

Advancements in contraceptive formulation technology, such as the development of long-acting reversible contraceptives (LARCs) and new delivery techniques, influence market trends. These innovations can make TAYTULLA and other contraceptives more convenient and effective, thereby expanding their market reach[4].

Cultural and Economic Factors

Cultural and religious attitudes towards family planning can significantly impact the adoption of contraceptive drugs. In regions with liberal attitudes towards reproductive rights, the demand for TAYTULLA and similar medications is likely to be higher. Additionally, rising disposable income and urbanization drive the sales of contraceptive medications as people become more financially stable and aware of reproductive health options[4].

Financial Performance of Allergan Pharmaceuticals

While the specific financial performance of TAYTULLA is not detailed in isolation, the overall sales figures indicate its contribution to Allergan Pharmaceuticals' revenue. The launch of generic versions, such as Merzee capsules by Lupin Pharma, can affect the pricing and revenue generated by TAYTULLA[1].

Risks and Contraindications

TAYTULLA, like other COCs, comes with several contraindications and warnings, including risks of blood clots, liver disease, high blood pressure, and gallbladder disease. These risks can impact patient adherence and, consequently, the drug's market performance[3].

Impact of Generic Versions

The introduction of generic versions, such as Merzee capsules, can significantly impact the financial trajectory of TAYTULLA. Generic drugs often offer lower prices, which can attract price-sensitive consumers and reduce the market share of the original drug[1][4].

Future Outlook

Given the growing demand for contraceptive medications and the expected market size of USD 20.3 billion by 2030, TAYTULLA is likely to remain a significant player in the market. However, its financial performance will be influenced by competition from generic versions, technological advancements, and changing regulatory and cultural landscapes[4].

Key Takeaways

• TAYTULLA generates substantial revenue, with annual sales of approximately USD 90 million in the US.
• The contraceptive drugs market is driven by factors such as the need to prevent unintended pregnancies and increasing awareness about contraceptive pills.
• Government and NGO initiatives, technological advancements, and cultural and economic factors influence the market dynamics.
• Generic versions and contraindications can impact the financial performance of TAYTULLA.
• The market is expected to grow significantly, reaching USD 20.3 billion by 2030.

FAQs

What are the primary drivers of the contraceptive drugs market?

The primary drivers include the need to prevent unintended pregnancies, increasing awareness about contraceptive pills, and government and NGO initiatives to promote family planning[1][4].

How much does TAYTULLA generate in annual sales in the US?

According to IQVIA MAT data for February 2022, TAYTULLA generates approximately USD 90 million in annual sales in the US[1][4].

What are the key contraindications and warnings associated with TAYTULLA?

TAYTULLA is contraindicated in women with blood clots, liver disease, high blood pressure, and certain other conditions. It also carries warnings for vascular risks, liver disease, and gallbladder disease[3].

How does the introduction of generic versions impact TAYTULLA's market position?

The introduction of generic versions, such as Merzee capsules, can reduce the market share and pricing of TAYTULLA due to lower prices offered by generic drugs[1][4].

What is the expected market size of the contraceptive drugs market by 2030?

The global contraceptive drugs market is expected to reach USD 20.3 billion by 2030, growing at a CAGR of 7.1%[4].

Sources

1. Market Research Future - Contraceptive Drugs Market Analysis
2. Taysha Gene Therapies - Full Year 2023 Financial Results
3. FDA - TAYTULLA Label
4. Market Research Future - Contraceptive Drugs Market Size
5. Taysha Gene Therapies - Second Quarter 2024 Financial Results