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Last Updated: December 22, 2024

WELLBUTRIN SR Drug Patent Profile


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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-seven 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 7th, 2000.

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Drug patent expirations by year for WELLBUTRIN SR
Drug Prices for WELLBUTRIN SR

See drug prices for WELLBUTRIN SR

Recent Clinical Trials for WELLBUTRIN SR

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

SponsorPhase
PfizerPhase 1
Mclean HospitalPhase 4
Kenya Medical Research InstitutePhase 4

See all WELLBUTRIN SR clinical trials

Pharmacology for WELLBUTRIN SR

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

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 020358-002 Oct 4, 1996 RE33994 ⤷  Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 5,427,798 ⤷  Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 5,763,493 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for WELLBUTRIN SR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017/059 Ireland ⤷  Subscribe 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; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 17C1058 France ⤷  Subscribe PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
0656775 CR 2000 00018 Denmark ⤷  Subscribe PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

WELLBUTRIN SR Market Analysis and Financial Projection Experimental

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

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