COMBIPATCH Drug Patent Profile

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

Combipatch is a drug marketed by Noven Pharms Inc and is included in one NDA.

The generic ingredient in COMBIPATCH is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combipatch

A generic version of COMBIPATCH was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17^th, 2008.

Summary for COMBIPATCH

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Drug Prices:	Drug price information for COMBIPATCH
DailyMed Link:	COMBIPATCH at DailyMed

See drug prices for COMBIPATCH

See drug sales revenues for COMBIPATCH

Pharmacology for COMBIPATCH

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for COMBIPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998		RX	Yes	No
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998		RX	Yes	Yes

Expired US Patents for COMBIPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	5,474,783
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,474,783
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	6,024,976
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,656,286
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,958,446
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	5,656,286

International Patents for COMBIPATCH

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

Country	Patent Number	Title	Estimated Expiration
Australia	632534
Australia	2833195
Brazil	9506470	COMPOSIÇÃO ADESIVA SENSÍVEL À PRESSÃO E SISTEMA DE DISTRIBUIÇÃO TRANSDÉRMICA DE DROGA.
European Patent Office	0591432	SYSTEME D'APPORT DE MEDICAMENTS FONDE SUR UN PARAMETRE DE SOLUBILITE ET PROCEDE MODIFIANT LA CONCENTRATION DE SATURATION D'UN MEDICAMENT (SOLUBILITY PARAMETER BASED DRUG DELIVERY SYSTEM AND METHOD FOR ALTERING DRUG SATURATION CONCENTRATION)
Norway	307363
World Intellectual Property Organization (WIPO)	9215289

Supplementary Protection Certificates for COMBIPATCH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Market Dynamics and Financial Trajectory for COMBIPATCH

Introduction

COMBIPATCH, a combination transdermal hormone therapy patch developed by Noven Pharmaceuticals, has been a significant player in the treatment of menopausal symptoms, particularly for postmenopausal women with a uterus. Here, we delve into the market dynamics and financial trajectory of COMBIPATCH, highlighting its position within the broader endometriosis and menopause treatment markets.

Market Context

The global endometriosis treatment market, while distinct, overlaps with the menopause treatment market in terms of hormone therapies. The endometriosis treatment market was valued at USD 1,222.2 million in 2022 and is expected to grow at a CAGR of 13.5% from 2023 to 2030, reaching USD 3.2 billion by 2030[1].

Product Overview

COMBIPATCH is a transdermal system containing both estrogen (estradiol) and progestin (norethindrone acetate), designed to treat moderate to severe hot flashes and vaginal dryness associated with menopause in women who still have their uterus[4].

Route of Administration

The transdermal route of administration is a key factor in the market dynamics of COMBIPATCH. This method bypasses first-pass metabolism, increasing the efficacy of the treatment. The patch is available in two dosage options: 0.05/0.25 mg/day and 0.05/0.14 mg/day[4].

Market Segments

Route of Administration Outlook

The oral route of administration dominates the endometriosis treatment market, but the transdermal segment is growing. COMBIPATCH falls under the "Others" category in the route of administration segment, which is expected to witness a CAGR of 5.35% during the forecast period. This growth is driven by the increased efficacy and convenience of transdermal drug delivery systems[1].

Distribution Channels

The retail pharmacy segment dominates the distribution channels for endometriosis treatments, accounting for 67.4% of the market share in 2022. COMBIPATCH, being available through retail pharmacies, benefits from this trend. The high presence of over-the-counter drugs and the rising volume of prescriptions for endometriosis and menopause treatments further support this segment's growth[1].

Competitive Landscape

The market for hormone therapies is competitive, with several key players involved. Noven Pharmaceuticals, the developer of COMBIPATCH, operates within this competitive landscape. Other notable players include Bayer AG, Pfizer, Inc., and AbbVie, Inc., which are also involved in strategic collaborations and new product launches to expand their market share[1].

Financial Performance

While specific financial data for COMBIPATCH is not readily available, its performance can be inferred from the broader market trends and the financial health of its parent company.

Revenue and Growth

The growth of the endometriosis treatment market and the increasing demand for hormone therapies suggest a positive financial trajectory for COMBIPATCH. The transdermal segment's growth rate, though lower than the oral segment, indicates a steady and increasing revenue stream for products like COMBIPATCH.

Pricing and Accessibility

The retail price of COMBIPATCH varies by pharmacy but generally ranges between $279.96 and $292.36. However, with discounts and coupons, the price can be reduced, making the product more accessible to patients. For example, SingleCare offers a discounted price of $240 to $258.99[5].

Clinical and Therapeutic Impact

COMBIPATCH has been clinically studied and proven effective in treating menopausal symptoms. It has shown significant relief in moderate to severe vasomotor symptoms and has a high adherence rate, with nearly 90% of the patches adhering to the skin over the 3- to 4-day wear period[3].

Regional Market Dynamics

The Asia Pacific region is expected to witness significant growth in the endometriosis treatment market, with a CAGR of 14.83% over the forecast period. This growth is driven by an increase in disease cases and strategic initiatives by market players for regional expansion. While COMBIPATCH is primarily marketed in the U.S., its potential for expansion into other regions could further boost its financial performance[1].

Strategic Initiatives and Collaborations

Strategic collaborations and licensing agreements are crucial in the pharmaceutical industry. For instance, the strategic licensing agreement between ObsEva SA and Theramex to expand linzagolix outside of the U.S., Canada, and Asia highlights the importance of such partnerships. Similar collaborations could enhance the market reach and financial performance of COMBIPATCH[1].

Challenges and Opportunities

Regulatory Environment

The pharmaceutical industry is heavily regulated, and unexpected regulatory actions or delays can impact product sales. However, compliance with regulatory standards and obtaining necessary approvals can also open up new markets and opportunities for products like COMBIPATCH[2].

Research and Development

Continuous research and development are essential for maintaining market competitiveness. Innovations in transdermal drug delivery systems and expanding the therapeutic indications of COMBIPATCH could drive future growth and revenue[1].

Key Takeaways

• Market Growth: The endometriosis treatment market is growing, driven by increasing demand for hormone therapies.
• Transdermal Segment: The transdermal segment, where COMBIPATCH operates, is expected to grow at a CAGR of 5.35%.
• Distribution Channels: Retail pharmacies dominate the distribution channels, benefiting COMBIPATCH.
• Clinical Impact: COMBIPATCH has a significant therapeutic impact, with high adherence rates and effective symptom relief.
• Regional Expansion: Potential for expansion into growing regions like Asia Pacific.
• Strategic Initiatives: Collaborations and licensing agreements can enhance market reach and financial performance.

FAQs

1. What is COMBIPATCH used for?

   • COMBIPATCH is used to treat moderate to severe hot flashes and vaginal dryness associated with menopause in postmenopausal women who still have their uterus[4].

2. How is COMBIPATCH administered?

   • COMBIPATCH is administered via a transdermal patch, available in two dosage options: 0.05/0.25 mg/day and 0.05/0.14 mg/day[4].

3. What is the expected growth rate of the transdermal segment in the endometriosis treatment market?

   • The transdermal segment is expected to witness a CAGR of 5.35% during the forecast period[1].

4. Which distribution channel dominates the endometriosis treatment market?

   • The retail pharmacy segment dominates the distribution channels, accounting for 67.4% of the market share in 2022[1].

5. What are the potential challenges for COMBIPATCH in the market?

   • Regulatory challenges, competition from other hormone therapies, and the need for continuous research and development are potential challenges for COMBIPATCH[1][2].

Cited Sources

1. Grand View Research: Endometriosis Treatment Market Size & Trends Report, 2030
2. Novartis: Novartis 20-F 2014
3. FDA: CombiPatch - accessdata.fda.gov
4. Noven Pharmaceuticals: CombiPatch
5. SingleCare: Combipatch Coupons & Prices - SingleCare