WELLBUTRIN SR Drug Patent Profile

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

Wellbutrin Sr is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in WELLBUTRIN SR is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Wellbutrin Sr

A generic version of WELLBUTRIN SR was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7^th, 2000.

Summary for WELLBUTRIN SR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	85
Patent Applications:	1,256
Drug Prices:	Drug price information for WELLBUTRIN SR
DailyMed Link:	WELLBUTRIN SR at DailyMed

See drug prices for WELLBUTRIN SR

Recent Clinical Trials for WELLBUTRIN SR

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

Sponsor	Phase
Pfizer	Phase 1
Mclean Hospital	Phase 4
National Cancer Institute (NCI)	Phase 4

See all WELLBUTRIN SR clinical trials

Pharmacology for WELLBUTRIN SR

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

US Patents and Regulatory Information for WELLBUTRIN SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996		DISCN	No	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996	AB1	RX	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	AB1	RX	Yes	No
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	AB1	RX	Yes	Yes

Expired US Patents for WELLBUTRIN SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-001	Oct 4, 1996	5,731,000
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-003	Oct 4, 1996	5,358,970
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-002	Oct 4, 1996	5,427,798
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	5,427,798
Glaxosmithkline	WELLBUTRIN SR	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020358-004	Jun 14, 2002	RE33994

International Patents for WELLBUTRIN SR

See the table below for patents covering WELLBUTRIN SR around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	161422
Denmark	0711154
European Patent Office	0711154	COMPOSITION PHARMACEUTIQUE STABILISEE CONTENANT DU BUPROPION (STABILIZED PHARMACEUTICAL COMPOSITION CONTAINING BUPROPION)
Israel	110513
Latvia	5758	Sastavs aktiva ingredienta kontroletai padevei

Supplementary Protection Certificates for WELLBUTRIN SR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Wellbutrin SR

Introduction to Wellbutrin SR

Wellbutrin SR, also known as bupropion hydrochloride, is a medication primarily used for the treatment of major depressive disorder (MDD) and, in some cases, for smoking cessation under the brand name Zyban. Here, we will delve into the market dynamics and financial trajectory of Wellbutrin SR.

Market Overview

Wellbutrin SR is part of the broader antidepressant market, which is a significant segment within the pharmaceutical industry. The antidepressant market is driven by the increasing prevalence of mental health disorders and the growing awareness and acceptance of mental health treatments.

Brand vs. Generic Versions

The market for Wellbutrin SR is influenced by the presence of both brand-name and generic versions. The brand-name version, Wellbutrin SR, is manufactured by Bausch Health (formerly Valeant Pharmaceuticals), while generic versions are produced by various manufacturers, including Dr. Reddy's Laboratories[1].

Financial Performance of Wellbutrin SR

Revenue

Wellbutrin SR generates substantial revenue for its manufacturers. In 2021, Wellbutrin contributed $254 million to Bausch Health's revenue, making it one of the company's top diversified products[5].

Generic Competition

The introduction of generic versions has impacted the financial trajectory of Wellbutrin SR. Generic bupropion hydrochloride extended-release tablets, such as those launched by Dr. Reddy's Laboratories, offer a more affordable alternative, which can reduce the market share and revenue of the brand-name drug. For instance, the generic version of Zyban had U.S. sales of approximately $5.4 million for the twelve months ending in June 2019[1].

Pricing and Cost Considerations

Cost Without Insurance

The cost of Wellbutrin SR without insurance can be significant, varying based on dosage, pharmacy, and available savings programs. The cash price, which is the cost without insurance or discounts, can be high, but it is generally lower with insurance coverage[2].

Savings Programs and Discounts

To make the medication more affordable, patients can explore savings programs, coupons, and the option of obtaining a 90-day supply, which can reduce the number of pharmacy visits and lower costs[2].

Bioequivalence and Regulatory Issues

Bioequivalence Studies

The generic versions of Wellbutrin SR have faced regulatory scrutiny due to concerns over bioequivalence. For example, the FDA-sponsored study in 2012 found that the generic version Budeprion XL 300 mg failed to demonstrate bioequivalence to Wellbutrin XL 300 mg, highlighting differences in absorption rates and peak concentrations[4].

Impact on Market Dynamics

These regulatory issues can affect consumer confidence and prescribing patterns. Patients who experience lack of efficacy or increased side effects with generic versions may switch back to the brand-name drug, influencing market dynamics and revenue streams.

Safety and Efficacy Concerns

Warnings and Precautions

Wellbutrin SR comes with several warnings and precautions, including the risk of suicidal thoughts and behaviors, seizures, hypertension, activation of mania/hypomania, and other neuropsychiatric reactions. These safety concerns are crucial for both brand-name and generic versions and can impact prescribing decisions[3].

Adverse Reactions

The medication's adverse reaction profile, including common reactions like headache and more severe reactions such as psychosis and angle-closure glaucoma, also plays a role in its market dynamics. Patients and healthcare providers must weigh the benefits against the potential risks, which can influence market demand.

Market Trends and Future Outlook

Growing Demand for Antidepressants

The increasing prevalence of mental health disorders and the expanding awareness of mental health treatments are expected to drive the demand for antidepressants, including Wellbutrin SR.

Generic Market Competition

The presence of multiple generic manufacturers will continue to exert pressure on the pricing of Wellbutrin SR, potentially reducing the revenue for brand-name versions but making the medication more accessible to a broader patient population.

Regulatory Environment

The regulatory environment, particularly the FDA's stance on bioequivalence and safety, will remain a critical factor in shaping the market dynamics for Wellbutrin SR. Ensuring that generic versions meet stringent bioequivalence standards is essential for maintaining consumer trust and ensuring the efficacy and safety of the medication.

Key Takeaways

• Revenue Contribution: Wellbutrin SR is a significant revenue generator for its manufacturers, with $254 million in revenue for Bausch Health in 2021.
• Generic Competition: The introduction of generic versions impacts the market share and revenue of the brand-name drug.
• Pricing and Cost: The cost of Wellbutrin SR varies based on dosage, pharmacy, and insurance coverage, with savings programs and discounts available to reduce costs.
• Bioequivalence Issues: Regulatory concerns over bioequivalence can affect consumer confidence and prescribing patterns.
• Safety and Efficacy: The medication comes with several warnings and precautions, influencing prescribing decisions and market dynamics.
• Market Trends: Growing demand for antidepressants and generic market competition will continue to shape the market for Wellbutrin SR.

FAQs

1. What is Wellbutrin SR used for? Wellbutrin SR is primarily used for the treatment of major depressive disorder (MDD) and, in some cases, for smoking cessation under the brand name Zyban.

2. How does the cost of Wellbutrin SR vary? The cost of Wellbutrin SR varies based on dosage, the pharmacy used, and available savings programs. It is generally lower with insurance coverage than without.

3. What are the common adverse reactions to Wellbutrin SR? Common adverse reactions include headache, while more severe reactions can include seizures, hypertension, activation of mania/hypomania, and other neuropsychiatric reactions.

4. Why have there been concerns over generic versions of Wellbutrin SR? Generic versions have faced regulatory scrutiny due to concerns over bioequivalence, with some studies showing differences in absorption rates and peak concentrations compared to the brand-name version.

5. How does the regulatory environment impact the market for Wellbutrin SR? The regulatory environment, particularly the FDA's stance on bioequivalence and safety, is crucial in shaping market dynamics. Ensuring generic versions meet stringent bioequivalence standards is essential for maintaining consumer trust and ensuring efficacy and safety.

Sources

1. Dr. Reddy's Laboratories announces the launch of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) - Biospace
2. Wellbutrin cost 2024: Coupons and more - MedicalNewsToday
3. Wellbutrin SR - FDA
4. The Generic Wellbutrin Problem: Whose Fault Is It? - Science | AAAS
5. Top diversified products of Bausch Health 2021 - Statista