BALCOLTRA Drug Patent Profile

Which patents cover Balcoltra, and when can generic versions of Balcoltra launch?

Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Balcoltra

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BALCOLTRA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for BALCOLTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALCOLTRA
What excipients (inactive ingredients) are in BALCOLTRA?	BALCOLTRA excipients list
DailyMed Link:	BALCOLTRA at DailyMed

See drug prices for BALCOLTRA

Paragraph IV (Patent) Challenges for BALCOLTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14

US Patents and Regulatory Information for BALCOLTRA

BALCOLTRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	AB3	RX	Yes	Yes				Y

Expired US Patents for BALCOLTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018

International Patents for BALCOLTRA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2002331603
South Africa	200401218	Enhancing solubility of iron amino acid chelates and iron proteinates.
Spain	2303739	AUMENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS CON HIERRO Y PROTEINATOS DE HIERRO.

Supplementary Protection Certificates for BALCOLTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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

Market Dynamics and Financial Trajectory for BALCOLTRA

Introduction to BALCOLTRA

BALCOLTRA is a combined hormonal contraceptive (CHC) that includes levonorgestrel and ethinyl estradiol tablets, along with ferrous bisglycinate tablets. It is indicated for use by females of reproductive potential to prevent pregnancy[2][4][5].

Market Context: Contraceptive Drugs and Devices

The global contraceptive drugs and devices market is experiencing significant growth, driven by increasing awareness about contraception, government initiatives, and the rising prevalence of sexually transmitted diseases (STDs) and unintended pregnancies. By 2034, this market is projected to reach USD 55.86 billion, growing at a CAGR of 5.93% from 2024 to 2034[1].

Segmentation and Distribution Channels

The contraceptive drugs and devices market is segmented by product, distribution channels, and geography. BALCOLTRA falls under the oral contraceptive segment, which is a key part of the market. Distribution channels play a crucial role, with retail pharmacies dominating the market in 2023. However, online channels are expected to grow rapidly due to increasing adoption of over-the-counter services and various online discounts[1].

Geographical Market Performance

The Asia Pacific region dominates the contraceptive drugs and devices market, driven by the increasing prevalence of unwanted pregnancies and STDs, as well as rising population and government initiatives. North America, particularly the U.S., is also expected to grow rapidly due to widespread access to contraceptive measures and increasing government awareness campaigns[1].

Product Specifics and Regulatory Approval

BALCOLTRA is approved by the FDA and is indicated for the prevention of pregnancy. It consists of 21 active tablets containing levonorgestrel and ethinyl estradiol, followed by 7 inactive tablets containing ferrous bisglycinate. The product was approved via the 505(b)(2) regulatory pathway, leveraging the bioequivalence of the generic drug Falmina to the reference listed drug Lutera[4][5].

Risk-Benefit Assessment and Safety Profile

The risk-benefit assessment of BALCOLTRA is similar to other combined hormonal contraceptives. It carries risks such as venous and arterial thrombotic events, liver disease, and gallbladder disease. The product is contraindicated in women over 35 years old who smoke due to increased cardiovascular risks. Despite these risks, the overall safety profile is considered favorable, especially when used as directed[2][4][5].

Market Growth Drivers

Several factors drive the market growth for BALCOLTRA and similar contraceptive products:

• Increasing Awareness and Government Initiatives: Government efforts to spread awareness about contraception and control population growth are significant drivers.
• Rising Prevalence of STDs and Unintended Pregnancies: The need to mitigate these issues fuels the demand for contraceptive measures.
• Advanced Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in regions like North America and the Asia Pacific, enhance market growth[1].

Financial Trajectory

While specific financial data for BALCOLTRA is not provided, the overall contraceptive drugs and devices market is expected to see substantial growth. Here are some key financial projections:

• Global Market Size: The global market size was USD 31.40 billion in 2024 and is projected to reach USD 55.86 billion by 2034.
• CAGR: The market is expected to grow at a CAGR of 5.93% from 2024 to 2034.
• Regional Growth: The Asia Pacific market, which is the largest, is expected to grow at a CAGR of 6.07% during the forecast period[1].

Distribution and Sales Channels

The retail pharmacy segment currently dominates the distribution of contraceptive drugs, including BALCOLTRA. However, online channels are gaining traction due to their convenience and availability of various brands and products. This shift is expected to contribute to the financial growth of the product[1].

Competitive Landscape

The contraceptive market is competitive, with numerous products available. BALCOLTRA competes with other combined hormonal contraceptives, such as Lutera and Alesse. The competitive landscape is influenced by factors like product efficacy, safety profile, and distribution channels[4].

Key Takeaways

• Market Growth: The global contraceptive drugs and devices market is projected to grow significantly, driven by increasing awareness and government initiatives.
• Product Safety: BALCOLTRA has a favorable safety profile but carries specific risks that need to be managed.
• Distribution Channels: Retail pharmacies and online channels are crucial for the distribution and sales of BALCOLTRA.
• Geographical Performance: The Asia Pacific and North America regions are key markets for BALCOLTRA and similar products.

FAQs

Q: What is BALCOLTRA used for? A: BALCOLTRA is used by females of reproductive potential to prevent pregnancy. It is a combined hormonal contraceptive (CHC) that includes levonorgestrel and ethinyl estradiol tablets, along with ferrous bisglycinate tablets[2][4][5].

Q: What are the key risks associated with BALCOLTRA? A: BALCOLTRA carries risks such as venous and arterial thrombotic events, liver disease, and gallbladder disease. It is contraindicated in women over 35 years old who smoke due to increased cardiovascular risks[2][4][5].

Q: How is BALCOLTRA distributed? A: BALCOLTRA is primarily distributed through retail pharmacies, but online channels are also gaining traction due to their convenience and availability of various brands and products[1].

Q: What is the projected market size for the global contraceptive drugs and devices market by 2034? A: The global contraceptive drugs and devices market is projected to reach USD 55.86 billion by 2034, growing at a CAGR of 5.93% from 2024 to 2034[1].

Q: Which region dominates the contraceptive drugs and devices market? A: The Asia Pacific region dominates the contraceptive drugs and devices market, driven by the increasing prevalence of unwanted pregnancies and STDs, as well as rising population and government initiatives[1].

Sources

1. Precedence Research: Contraceptive Drugs and Devices Market Size to Hit USD 55.86 Bn ...
2. FDA: Balcoltra HIGHLIGHTS OF PRESCRIBING INFORMATION
3. CITIline: FY 2018 PDUFA Performance Report
4. FDA: 208612Orig1s000 - accessdata.fda.gov
5. Balcoltra: Balcoltra-PI.pdf