FEMARA Drug Patent Profile

When do Femara patents expire, and what generic alternatives are available?

Femara is a drug marketed by Novartis Pharms and is included in one NDA.

The generic ingredient in FEMARA is letrozole. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Femara

A generic version of FEMARA was approved as letrozole by ACCORD HLTHCARE on June 3^rd, 2011.

Summary for FEMARA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	196
Patent Applications:	3,462
Drug Prices:	Drug price information for FEMARA
What excipients (inactive ingredients) are in FEMARA?	FEMARA excipients list
DailyMed Link:	FEMARA at DailyMed

See drug prices for FEMARA

Recent Clinical Trials for FEMARA

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

Sponsor	Phase
GOG Foundation	Phase 3
European Network of Gynaecological Oncological Trial Groups (ENGOT)	Phase 3
Verastem, Inc.	Phase 3

See all FEMARA clinical trials

Pharmacology for FEMARA

Drug Class	Aromatase Inhibitor
Mechanism of Action	Aromatase Inhibitors

Paragraph IV (Patent) Challenges for FEMARA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FEMARA	Tablets	letrozole	2.5 mg	020726	1	2006-03-02

US Patents and Regulatory Information for FEMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726-001	Jul 25, 1997	AB	RX	Yes	Yes

Expired US Patents for FEMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726-001	Jul 25, 1997	4,978,672

International Patents for FEMARA

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	279028	SUBSTITUTED IMIDAZOLYL- OR 1,2,4-TRIAZOLYL METHYL BENZONITRILES
U.S.S.R.	1577695	CПOCOБ ПOЛУЧEHИЯ ГETEPOЦИKЛOЗAMEЩEHHЫX TOЛУHИTPИЛOB ИЛИ ИX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ (METHOD OF OBTAINING HETEROCYCLOSUBSTITUTED TIOLUNITRILES OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF)
Slovakia	279102
U.S.S.R.	1470184	CПOCOБ ПOЛУЧEHИЯ ГETEPOЦИKЛOЗAMEЩEHHЫX TOЛУHИTPИЛOB ИЛИ ИX ФAPMAЦEBTИЧECKИX ПPИEMЛEMЫX COЛEЙ (METHOD OF PRODUCING HETEROCYCLO-SUBSTITUTED THOLUNITRILS OF THEIR PHARMACEUTICALLY ACCEPTABLE SALTS)
Czech Republic	279027	PROCESS FOR PREPARING TOLUNITRILES SUBSTITUTED BY HETEROCYCLIC RADICAL
Bulgaria	45700	METHOD FOR PREPARING OF ALPHA- HETEROCYCLIC SUBSTITUTED TOLUNITRILES

Supplementary Protection Certificates for FEMARA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236940	SPC/GB97/013	United Kingdom		PRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118
0236940	C970011	Netherlands		PRODUCT NAME: LETROZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; NAT. REGISTRATION: RVG 20755 19970106; FIRST REGISTRATION: FR NL 21 881 19960724
0236940	97C0053	Belgium		PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072

FEMARA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Femara

Introduction

Femara, a medication containing the active substance letrozole, is a crucial treatment in the management of breast cancer, particularly in postmenopausal women. This article delves into the market dynamics and financial trajectory of Femara, highlighting its therapeutic indications, market presence, and financial performance.

Therapeutic Indications

Femara is used as a hormonal treatment for various stages of breast cancer. It functions as an aromatase inhibitor, blocking the enzyme aromatase which is involved in the production of estrogen. This is particularly effective in hormone receptor-positive or hormone-dependent types of breast cancer, where estrogen stimulates the growth of cancer cells[1].

Adjuvant Treatment

Femara is used in the adjuvant treatment of hormone receptor-positive invasive early breast cancer, following surgery. It is also used in the extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years[1].

Advanced Breast Cancer

For advanced breast cancer, Femara is used as a first-line treatment and also after relapse or disease progression in women with natural or artificially induced postmenopausal endocrine status who have previously been treated with anti-estrogens[1].

Neo-Adjuvant Treatment

In cases where chemotherapy is not suitable and immediate surgery is not indicated, Femara is used in the neo-adjuvant treatment of hormone receptor-positive, HER-2 negative breast cancer[1].

Market Presence

Femara is marketed by Novartis and is available in all EU Member States under various trade names including Femar, Fémara, and Loxifan. The drug has been subject to harmonization efforts by the European Medicines Agency (EMA) to standardize its prescribing information across the EU[1].

Harmonization Efforts

The EMA's Committee for Medicinal Products for Human Use (CHMP) identified the need to harmonize the marketing authorizations for Femara. This led to the standardization of the summaries of product characteristics (SmPCs), labeling, and package leaflets across EU Member States. This harmonization ensures consistent use and safety guidelines for the medication[1].

Clinical Efficacy

Clinical studies have demonstrated the efficacy of Femara compared to tamoxifen. For instance, Femara showed a superior time to progression (TTP) and objective tumor response rate in patients with advanced breast cancer. The median TTP was 9.4 months for Femara compared to 6.0 months for tamoxifen, with a hazard ratio of 0.72 favoring Femara[5].

Safety Profile

Femara has a distinct safety profile compared to tamoxifen. It has a lower incidence of thromboembolic events and endometrial hyperplasia or cancer but a higher incidence of fractures. These differences highlight the need for careful patient selection and monitoring[3].

Financial Performance

The financial performance of Femara is closely tied to the overall pharmaceutical market and the strategies of its manufacturer, Novartis.

Revenue Contribution

As part of Novartis's oncology portfolio, Femara contributes to the company's revenue. However, specific financial data for Femara is not typically disclosed separately from the broader oncology segment. Novartis's oncology sales have shown significant growth, driven by various new medicines, which indirectly reflects the market performance of drugs like Femara[2][4].

Market Trends

The oncology market, including breast cancer treatments, has seen substantial growth driven by advancements in therapies and increasing demand. Emerging markets, particularly in regions like China, have been a significant driver of this growth. While Femara's specific revenue figures are not detailed, the overall trend in oncology sales suggests a robust market for breast cancer treatments[2][4].

Competitive Landscape

Femara operates in a competitive landscape with other breast cancer treatments. The market includes other aromatase inhibitors and anti-estrogen therapies. The competitive edge of Femara is maintained through its proven efficacy, safety profile, and the harmonized regulatory framework across the EU[1].

Regulatory Impact

Regulatory harmonization and standardization have played a crucial role in Femara's market dynamics. The EMA's efforts to align prescribing information and safety guidelines have ensured that Femara is used consistently across different regions, which can positively impact its market presence and patient outcomes[1].

Patient Access and Affordability

Patient access and affordability are critical factors in the market dynamics of Femara. The drug's availability under various trade names and the efforts to harmonize its use across the EU help in ensuring that it is accessible to a broader patient population. However, affordability can be influenced by regional healthcare policies and reimbursement schemes[1].

Future Outlook

The future outlook for Femara is tied to the evolving landscape of breast cancer treatments. With ongoing research and development in oncology, there may be new therapies emerging that could impact Femara's market share. However, its established efficacy and safety profile position it as a continued option for postmenopausal women with hormone receptor-positive breast cancer.

Key Takeaways

• Therapeutic Indications: Femara is used in various stages of breast cancer, including adjuvant, extended adjuvant, first-line, and neo-adjuvant treatments.
• Market Presence: Marketed by Novartis, available in all EU Member States under different trade names.
• Harmonization Efforts: Standardized prescribing information and safety guidelines across the EU.
• Clinical Efficacy: Demonstrated superior TTP and objective tumor response rates compared to tamoxifen.
• Financial Performance: Contributes to Novartis's oncology revenue, with growth driven by emerging markets.
• Competitive Landscape: Operates in a competitive market with other aromatase inhibitors and anti-estrogen therapies.
• Regulatory Impact: Harmonization efforts by the EMA ensure consistent use and safety guidelines.
• Patient Access and Affordability: Affected by regional healthcare policies and reimbursement schemes.

FAQs

What is Femara used for?

Femara is used as a hormonal treatment for breast cancer in postmenopausal women, particularly for hormone receptor-positive or hormone-dependent types of breast cancer.

Who manufactures Femara?

Femara is manufactured and marketed by Novartis.

What are the main therapeutic indications for Femara?

Femara is indicated for adjuvant treatment of hormone receptor-positive invasive early breast cancer, extended adjuvant treatment, first-line treatment for hormone-dependent advanced breast cancer, and neo-adjuvant treatment in certain cases.

How does Femara compare to tamoxifen in clinical studies?

Femara has shown a superior time to progression and objective tumor response rate compared to tamoxifen in clinical studies.

What are the safety concerns associated with Femara?

Femara has a higher incidence of fractures compared to tamoxifen but a lower incidence of thromboembolic events and endometrial hyperplasia or cancer.

Sources

1. European Medicines Agency - Femara - referral | European Medicines Agency (EMA) - Europa.eu
2. AstraZeneca - Full-year and Q4 2019 results - AstraZeneca
3. Novartis - FEMARA | Novartis
4. AstraZeneca - results announcement - AstraZeneca
5. FDA - Femara - accessdata.fda.gov