CONTRAVE Drug Patent Profile
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Which patents cover Contrave, and what generic alternatives are available?
Contrave is a drug marketed by Nalpropion and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifty-nine patent family members in forty-three countries.
The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Contrave
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 21, 2024. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for CONTRAVE
| International Patents: | 259 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 20 |
| Patent Applications: | 275 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CONTRAVE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CONTRAVE |
| What excipients (inactive ingredients) are in CONTRAVE? | CONTRAVE excipients list |
| DailyMed Link: | CONTRAVE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CONTRAVE
Generic Entry Date for CONTRAVE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CONTRAVE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novo Nordisk A/S | Phase 4 |
| University of California, Los Angeles | Early Phase 1 |
| Zuyderland Medisch Centrum | Phase 4 |
Pharmacology for CONTRAVE
| Drug Class | Aminoketone Opioid Antagonist |
| Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Opioid Antagonists |
| Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Anatomical Therapeutic Chemical (ATC) Classes for CONTRAVE
Paragraph IV (Patent) Challenges for CONTRAVE
| 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 CONTRAVE
CONTRAVE is protected by twenty US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CONTRAVE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting CONTRAVE
Compositions and methods for weight loss in at risk patient populations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Methods for administering weight loss medications
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
Methods of treating overweight and obesity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Compositions and methods for weight loss in at risk patient populations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Methods of providing weight loss therapy in patients with major depression
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Methods of treating overweight and obesity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Compositions for affecting weight loss
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Methods for treating visceral fat conditions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Compositions for affecting weight loss
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions for affecting weight loss
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Layered pharmaceutical formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Layered pharmaceutical formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
Methods for administering weight loss medications
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
Compositions and methods for increasing insulin sensitivity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
Sustained release formulation of naltrexone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Sustained release formulation of naltrexone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
Methods for administering weight loss medications
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
Methods of providing weight loss therapy in patients with major depression
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALTREXONE AND BUPROPION FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER
Methods of treating overweight and obesity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063-001 | Sep 10, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CONTRAVE
See the table below for patents covering CONTRAVE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2858640 | Composition à être utilisée dans une méthode de traitement de la surcharge pondérale et de l'obésité dans de patients présentant un risque cardiovasculaire élevé (Composition for use in a method of treating overweight and obesity in patients with high cardiovascular risk) | ⤷ Try a Trial |
| Lithuania | 3730132 | ⤷ Try a Trial | |
| Japan | 2009539837 | ⤷ Try a Trial | |
| China | 114404419 | 降低主要不良心血管事件的组合物和方法 (Compositions and methods for reducing major adverse cardiovascular events) | ⤷ Try a Trial |
| South Korea | 20170077291 | 단위 용량 팩키지 (Unit dosage packages) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CONTRAVE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | CR 2017 00062 | Denmark | ⤷ Try a Trial | 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 | SPC/GB17/078 | United Kingdom | ⤷ Try a Trial | 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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | 17C1058 | France | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201 |
| 2316456 | 132017000142109 | Italy | ⤷ Try a Trial | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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