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Last Updated: April 18, 2025

Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details


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What are the generic sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of patent protection?

Bupropion hydrochloride; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Nalpropion and is included in one NDA. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; naltrexone hydrochloride has two hundred and forty-five patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; naltrexone hydrochloride
Recent Clinical Trials for bupropion hydrochloride; naltrexone hydrochloride

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

SponsorPhase
Currax PharmaceuticalsPhase 4
University of California, Los AngelesEarly Phase 1
Zuyderland Medisch CentrumPhase 4

See all bupropion hydrochloride; naltrexone hydrochloride clinical trials

Pharmacology for bupropion hydrochloride; naltrexone hydrochloride
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CONTRAVE Extended-release Tablets bupropion hydrochloride; naltrexone hydrochloride 8 mg/90 mg 200063 1 2015-03-12

US Patents and Regulatory Information for bupropion hydrochloride; naltrexone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 10,231,964 ⤷  Try for Free ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 9,633,575 ⤷  Try for Free ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 11,998,542 ⤷  Try for Free ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 10,403,170 ⤷  Try for Free ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 8,088,786 ⤷  Try for Free Y ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 9,248,123 ⤷  Try for Free ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes 7,375,111 ⤷  Try for Free Y ⤷  Try for Free
>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 bupropion hydrochloride; naltrexone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 7,462,626 ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 8,815,889 ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 11,278,544 ⤷  Try for Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 7,375,111 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bupropion hydrochloride; naltrexone hydrochloride

Country Patent Number Title Estimated Expiration
Japan 6240140 ⤷  Try for Free
Japan 6665094 ⤷  Try for Free
South Korea 102472432 ⤷  Try for Free
Brazil 112016012755 USO DE 4 A 50 MG DE NALTREXONA DE LIBERAÇÃO SUSTENTADA, OU UM SAL FARMACEUTICAMENTE ACEITÁVEL DA MESMA E 50 A 400MG DE BUPROPIONA, OU UM SAL FARMACEUTICAMENTE ACEITÁVEL DA MESMA ⤷  Try for Free
Taiwan 200808319 Sustained release formulation of naltrexone ⤷  Try for Free
Eurasian Patent Organization 201492175 СПОСОБЫ ЛЕЧЕНИЯ ИЗБЫТОЧНОГО ВЕСА И ОЖИРЕНИЯ ⤷  Try for Free
Japan 2014005310 SUSTAINED RELEASE FORMULATION OF NALTREXONE ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bupropion hydrochloride; naltrexone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0656775 28/2000 Austria ⤷  Try for Free PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456 CR 2017 00062 Denmark ⤷  Try for Free PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2316456 657 Finland ⤷  Try for Free
2316456 122017000109 Germany ⤷  Try for Free PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 2017C/064 Belgium ⤷  Try for Free PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 349 22-2017 Slovakia ⤷  Try for Free 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 132017000142109 Italy ⤷  Try for Free PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Drug: Bupropion Hydrochloride; Naltrexone Hydrochloride (Contrave)

Introduction

Contrave, a fixed-dose combination of bupropion hydrochloride and naltrexone hydrochloride, was approved by the FDA in 2014 for the treatment of obesity and weight management. This article delves into the market dynamics and financial trajectory of this drug, highlighting its challenges, safety profile, and future outlook.

Approval and Indications

Contrave is indicated for weight loss and maintenance of weight loss in adults with a body mass index (BMI) of 30 or higher, or in adults with a BMI of 27 or higher who have at least one weight-related condition such as type 2 diabetes, high blood pressure, or high cholesterol. The drug combines naltrexone, an opioid antagonist, and bupropion, a dopamine and norepinephrine reuptake inhibitor[1][5].

Market Challenges

Despite its approval, Contrave has faced several market challenges. One significant issue is the public perception and management of the drug's efficacy. For instance, the initial public release highlighting a 25% weight loss trajectory was seen as misleading, as the actual placebo-subtracted weight loss is around 4-5%[2].

Safety Profile and Adverse Events

The safety profile of Contrave is a critical aspect of its market dynamics. The drug has been associated with several adverse events, including increased risk of seizures, particularly at higher doses of bupropion. Other notable side effects include sleep disorders, anxiety, and hypertension. The risk of major adverse cardiovascular events (MACE) has also been a concern, although studies have shown that the risk does not significantly impact the drug’s benefit-risk profile[1][2][5].

Clinical Trials and Efficacy

Clinical trials have demonstrated that Contrave can achieve moderate weight loss. A large-scale randomized noninferiority cardiovascular outcomes trial showed a placebo-subtracted weight loss of 2.5% at 104 weeks. However, longer-term studies are needed to fully characterize the drug's efficacy and safety beyond one year[2].

Regulatory Requirements and Post-Marketing Studies

The FDA has mandated post-marketing studies to assess the cardiovascular safety of Contrave. A randomized, double-blind, placebo-controlled trial was required to demonstrate that the risk of MACE does not adversely affect the drug’s benefit-risk profile. These studies have been ongoing, with a focus on long-term safety and efficacy[5].

Patent and Generic Landscape

The patent landscape for bupropion hydrochloride, a key component of Contrave, is complex. The earliest date for generic entry of bupropion hydrobromide (a related salt form) is expected to be June 27, 2026, pending any patent challenges or generic licensing agreements. This could potentially impact the market dynamics of Contrave once generic versions become available[3].

Financial Trajectory

The financial performance of Contrave has been influenced by its market challenges and regulatory requirements. Despite being FDA-approved in 2014, the drug has not achieved the expected market penetration due to concerns over its safety profile and efficacy. The need for ongoing post-marketing studies and the impending generic competition are likely to impact its financial trajectory in the coming years.

Market Competition

Contrave operates in a competitive obesity treatment market, which includes other prescription drugs, lifestyle modifications, and surgical interventions. The drug's unique mechanism of action, combining an opioid antagonist with a dopamine and norepinephrine reuptake inhibitor, sets it apart but also introduces complexities in patient management and safety monitoring[2].

Patient Compliance and Adherence

Patient compliance and adherence are crucial for the success of any weight loss medication. Contrave requires a titration period to reach the maximum daily dosage, which can affect patient adherence. Additionally, the need for lifestyle modifications alongside medication can be a barrier to long-term compliance[1][5].

Future Outlook

The future outlook for Contrave is mixed. While it has shown efficacy in weight loss, ongoing safety concerns and the need for longer-term studies will continue to influence its market dynamics. The impending generic competition for bupropion hydrochloride could further impact its financial trajectory. However, if the drug can demonstrate long-term safety and efficacy, it may still maintain a significant market presence.

Key Takeaways

  • Approval and Indications: Contrave is approved for weight loss and maintenance in adults with a BMI of 30 or higher, or 27 or higher with weight-related conditions.
  • Market Challenges: Public perception, safety concerns, and regulatory requirements have impacted market performance.
  • Safety Profile: Associated with increased risk of seizures, sleep disorders, anxiety, and hypertension.
  • Clinical Trials: Demonstrated moderate weight loss, but longer-term studies are needed.
  • Regulatory Requirements: Ongoing post-marketing studies to assess cardiovascular safety.
  • Patent and Generic Landscape: Generic competition expected by June 27, 2026.
  • Financial Trajectory: Influenced by market challenges, regulatory requirements, and impending generic competition.
  • Market Competition: Operates in a competitive obesity treatment market.
  • Patient Compliance: Requires titration period and lifestyle modifications, affecting adherence.

FAQs

What are the active ingredients in Contrave?

Contrave contains naltrexone hydrochloride, an opioid antagonist, and bupropion hydrochloride, a dopamine and norepinephrine reuptake inhibitor[1].

What are the common side effects of Contrave?

Common side effects include sleep disorders, anxiety, hypertension, and an increased risk of seizures[1][2].

Is Contrave safe for long-term use?

Long-term safety data is still emerging, and ongoing studies are needed to fully characterize the drug's safety profile beyond one year[2].

When can we expect generic versions of bupropion hydrochloride?

The earliest date for generic entry of bupropion hydrobromide is expected to be June 27, 2026, pending any patent challenges or generic licensing agreements[3].

How does Contrave compare to other weight loss medications?

Contrave's unique mechanism of action sets it apart, but it faces competition from other prescription drugs, lifestyle modifications, and surgical interventions[2].

Sources

  1. FDA: NDA 200063 Orig1s000 ClinPharmR - Contrave (Naltrexone/Bupropion)[1].
  2. Tandfonline: Update on drug safety evaluation of naltrexone/bupropion for the treatment of obesity[2].
  3. Drug Patent Watch: Aplenzin (Bupropion Hydrobromide) - Patent and Generic Information[3].
  4. Health Canada: Product Monograph - Naltrexone Hydrochloride and Bupropion Hydrochloride Extended-Release Tablets[4].
  5. FDA: Summary Basis for Approval - NDA 200063 / CONTRAVE (naltrexone HCl/bupropion HCl)[5].

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