BYSTOLIC Drug Patent Profile

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

Bystolic is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bystolic

A generic version of BYSTOLIC was approved as nebivolol hydrochloride by ANI PHARMS on April 16^th, 2015.

Summary for BYSTOLIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	31
Patent Applications:	3,603
Drug Prices:	Drug price information for BYSTOLIC
Drug Sales Revenues:	Drug sales revenues for BYSTOLIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYSTOLIC
What excipients (inactive ingredients) are in BYSTOLIC?	BYSTOLIC excipients list
DailyMed Link:	BYSTOLIC at DailyMed

See drug prices for BYSTOLIC

See drug sales revenues for BYSTOLIC

Recent Clinical Trials for BYSTOLIC

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Martin M. Miner, MD	Phase 4
State University of New York at Buffalo	Phase 3

See all BYSTOLIC clinical trials

Pharmacology for BYSTOLIC

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for BYSTOLIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYSTOLIC	Tablets	nebivolol hydrochloride	2.5 mg, 5 mg, 10 mg, and 20 mg	021742	7	2011-12-19

US Patents and Regulatory Information for BYSTOLIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-002	Dec 17, 2007	AB	RX	Yes	No
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-005	Oct 8, 2008	AB	RX	Yes	Yes
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-003	Dec 17, 2007	AB	RX	Yes	No
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007	AB	RX	Yes	No

Expired US Patents for BYSTOLIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-002	Dec 17, 2007
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-005	Oct 8, 2008
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-004	Dec 17, 2007
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-003	Dec 17, 2007
Allergan	BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742-003	Dec 17, 2007

International Patents for BYSTOLIC

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0744946	COMPOSITIONS CONTENANT DU NEBIVOLOL MICRONISE (COMPOSITIONS CONTAINING MICRONIZED NEBIVOLOL)
Japan	H0637487
Denmark	0744946
Brazil	9506828
Hungary	9602272
South Africa	9501294

Supplementary Protection Certificates for BYSTOLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	SPC/GB96/048	United Kingdom		PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0334429	C950031	Netherlands		PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018

BYSTOLIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bystolic

Introduction

Bystolic, also known as nebivolol, is a prescription medication used to treat hypertension (chronic high blood pressure). Here, we will delve into the market dynamics and financial trajectory of Bystolic, exploring its acquisition, market performance, pricing, and the factors influencing its financial outlook.

Acquisition and Ownership

In 2012, Forest Laboratories, Inc. acquired the U.S. and Canadian intellectual property rights for Bystolic from Janssen Pharmaceutica NV for $357 million. This acquisition included all U.S. patents and know-how covering Bystolic, eliminating future royalties for Forest Laboratories[1].

Market Performance

Bystolic has shown significant growth since its approval by the U.S. Food and Drug Administration in 2007. It is the only branded beta-blocker in the U.S. market and represents over 4% of this large class of medications. Sales of Bystolic grew by 33% in the quarter ending December 31, 2011, compared to the same quarter the previous year[1].

Revenue Trends

In the fourth quarter of 2018, Bystolic and its combination product Byvalson generated net revenues of $151.7 million, a decrease of 3.7% from the prior year quarter. However, in the fourth quarter of 2019, Bystolic/Byvalson net revenues increased by 11.8% to $169.6 million compared to the prior year quarter[2][5].

Clinical Efficacy and Safety

Bystolic has been proven effective in treating mild to moderate essential hypertension through several clinical trials. The drug has shown incremental decreases in diastolic blood pressure with doses ranging from 2.5 mg to 20 mg, and its antihypertensive effect is maintained over a 24-hour dosing interval. It is well-tolerated, with a safety profile consistent with other beta-blockers[3].

Pricing and Cost Factors

High Drug Prices in the U.S.

Bystolic is expensive in the United States, with a one-month supply costing around $230 for thirty tablets, or approximately $7.60 per dose. This translates to nearly $3,000 per year for the brand-name version, which can be a significant financial burden even for those with insurance[4].

Reasons for High Costs

• Research and Development (R&D): The extensive process of researching and developing a drug like Bystolic involves significant costs, including hiring experts, using specialized facilities, and acquiring material resources.
• Limited Competition: Bystolic is a unique selective beta-1 receptor antagonist, which reduces competition and allows the manufacturer to maintain higher prices.
• Patent Protections: Although Bystolic's last patent expired in December 2021, its established market presence has allowed it to retain high prices.
• Marketing: Pharmaceutical companies invest heavily in marketing and advertising, which is factored into the final cost of the drug[4].

International Pricing and Alternatives

Patients often seek alternatives to high U.S. prices by purchasing medications from international pharmacies, particularly Canadian ones. Buying Bystolic from Canadian pharmacies can result in savings of up to 60%, with a one-month supply costing around $100 for thirty tablets[4].

Financial Impact on Manufacturers

The financial performance of Bystolic has been a significant factor in the financial reports of its manufacturers. For instance, Forest Laboratories and later Allergan (after the acquisition of Forest Laboratories) have reported substantial revenues from Bystolic sales. Despite fluctuations, Bystolic remains a valuable asset in their portfolios[2][5].

Risk Management and Safety Profile

Health Canada's review and the Risk Management Plan (RMP) submitted by Forest Laboratories Canada Inc. indicate that Bystolic has a favorable benefit/risk profile. The drug is well-tolerated, and its safety issues can be managed through appropriate labeling and precautions[3].

Market Competition

Bystolic operates in a competitive market with other beta-blockers and hypertension treatments. However, its unique properties and lower side effect profile have helped it maintain a strong market position. The expiration of its patent in 2021 has opened the door for generic versions, but Bystolic's brand reputation continues to support its market share[4].

Future Outlook

Given its established market presence and clinical efficacy, Bystolic is likely to continue being a significant player in the hypertension treatment market. However, the introduction of generic versions post-patent expiration may impact its revenue trajectory. The ongoing trend of patients seeking cheaper alternatives from international pharmacies could also influence its financial performance in the U.S. market.

Key Takeaways

• Acquisition and Ownership: Forest Laboratories acquired Bystolic from Janssen Pharmaceutica NV in 2012.
• Market Performance: Bystolic has shown significant growth and represents a substantial portion of the beta-blocker market.
• Clinical Efficacy: Proven effective in treating mild to moderate hypertension with a favorable safety profile.
• Pricing: High costs in the U.S. driven by R&D, limited competition, patent protections, and marketing expenses.
• International Alternatives: Significant savings can be achieved by purchasing from Canadian pharmacies.
• Financial Impact: Substantial revenues for manufacturers despite market fluctuations.
• Risk Management: Favorable benefit/risk profile with manageable safety issues.

FAQs

What is Bystolic used for?

Bystolic (nebivolol) is used to treat hypertension (chronic high blood pressure) and can be taken alone or in combination with other high blood pressure medications.

How much does Bystolic cost in the U.S.?

A one-month supply of Bystolic in the U.S. can cost around $230 for thirty tablets, or approximately $7.60 per dose.

Why is Bystolic so expensive?

Bystolic's high cost is due to factors such as extensive R&D, limited competition, patent protections, and significant marketing expenses.

Can I buy Bystolic cheaper from other countries?

Yes, buying Bystolic from Canadian pharmacies can result in savings of up to 60% compared to U.S. prices.

Is Bystolic safe to use?

Bystolic has a favorable safety profile, with common adverse events including headache, fatigue, and dizziness, and it is well-tolerated overall.

Sources

1. Forest Laboratories, Inc. Buys Blood Pressure Drug Bystolic From Johnson and Johnson's Janssen Pharmaceutica N.V. for $357 Million. Biospace.
2. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results. AbbVie News.
3. Summary Basis of Decision for Bystolic. Health Canada.
4. Why is Bystolic So Expensive & How to Get it Cheaper. Northwest Pharmacy.
5. Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results. AbbVie News.