MOVANTIK Drug Patent Profile
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When do Movantik patents expire, and when can generic versions of Movantik launch?
Movantik is a drug marketed by Valinor and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixteen patent family members in forty-four countries.
The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.
DrugPatentWatch® Generic Entry Outlook for Movantik
Movantik was eligible for patent challenges on September 16, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 2, 2032. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MOVANTIK?
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Summary for MOVANTIK
| International Patents: | 116 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 23 |
| Clinical Trials: | 14 |
| Patent Applications: | 77 |
| Drug Prices: | Drug price information for MOVANTIK |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MOVANTIK |
| What excipients (inactive ingredients) are in MOVANTIK? | MOVANTIK excipients list |
| DailyMed Link: | MOVANTIK at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MOVANTIK
*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 MOVANTIK
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Missouri-Columbia | Phase 4 |
| University of Tennessee, Chattanooga | N/A |
| Camille Ladanyi MD | N/A |
Pharmacology for MOVANTIK
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Paragraph IV (Patent) Challenges for MOVANTIK
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MOVANTIK | Tablets | naloxegol oxalate | 12.5 mg and 25 mg | 204760 | 2 | 2018-09-17 |
US Patents and Regulatory Information for MOVANTIK
MOVANTIK is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MOVANTIK is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 MOVANTIK
Polymer conjugates of opioid antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Chemically modified small molecules
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Chemically modified small molecules
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION
Crystalline naloxol-peg conjugate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 MOVANTIK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-002 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Valinor | MOVANTIK | naloxegol oxalate | TABLET;ORAL | 204760-001 | Sep 16, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MOVANTIK
When does loss-of-exclusivity occur for MOVANTIK?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3268
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 11307608
Patent: Crystalline naloxol-PEG conjugate
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013007113
Patent: conjugado de naloxol-peg cristalino
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 12649
Patent: CONJUGUE CRISTALLIN DE NALOXOL-PEG (CRYSTALLINE NALOXOL-PEG CONJUGATE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13000866
Patent: Sales cristalinas oxalato y fosfato del conjugado naloxolpolietilenglicol; metodo de preparacion; composicion farmaceutica que lo comprende; y su uso para el tratamiento del dolor.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3237547
Patent: Crystalline naloxol-eg conjugate
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 00851
Patent: Conjugado de naloxol-peg cristalino
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 130146
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0151420
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 317
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Patent: 130047
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17376
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 21496
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 13012531
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3929
Patent: КРИСТАЛЛИЧЕСКИЙ КОНЪЮГАТ НАЛОКСОЛ-PEG (CRYSTALLINE NALOXOL-PEG CONJUGATE)
Estimated Expiration: ⤷ Sign Up
Patent: 1300423
Patent: КРИСТАЛЛИЧЕСКИЙ КОНЪЮГАТ НАЛОКСОЛ-PEG
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 21496
Patent: CONJUGUÉ CRISTALLIN DE NALOXOL-PEG (CRYSTALLINE NALOXOL-PEG CONJUGATE)
Estimated Expiration: ⤷ Sign Up
Patent: 92903
Patent: COMBINAISON D'UN CONJUGUÉ NALOXOL-PEG AVEC UN AGONISTE OPIOÏDE (COMBINATION OF A NALOXOL-PEG CONJUGATE AND AN OPIOID AGONIST)
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 1300084
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 87248
Patent: 結晶納絡醇- 綴合物 (CRYSTALLINE NALOXOL-PEG CONJUGATE -PEG)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 26726
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 34789
Estimated Expiration: ⤷ Sign Up
Patent: 13538849
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 3890
Patent: CRYSTALLINE NALOXOL-PEG CONJUGATE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 13003587
Patent: CONJUGADOS DE NALOXOL-POLIETILENGLICOL CRISTALINOS. (CRYSTALLINE NALOXOL-PEG CONJUGATE.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 313
Patent: KRISTALNI KONJUGAT NALOKSOL-POLIETILEN GLIKOL (CRYSTALLINE NALOXOL-PEG CONJUGATE)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9874
Patent: Crystalline naloxol-peg conjugate
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1300034
Patent: CONJUGADO DE NALOXOL - PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 140636
Patent: CONJUGADO DE NALOXOL-PEG CRISTALINO
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 21496
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 21496
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600004
Patent: CONIUGATO CRISTALLINO DI NALOXOLO-PEG
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 1320808
Patent: مترافق نالوكسول-PEG بلوري (Crystalline Naloxol-PEG Conjugate)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 488
Patent: KRISTALNI KONJUGAT NALOKSOL-POLIETILEN GLIKOL (CRYSTALLINE NALOXOL-PEG CONJUGATE)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 8474
Patent: CRYSTALLINE NALOXOL-PEG CONJUGATE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 21496
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1791724
Estimated Expiration: ⤷ Sign Up
Patent: 130135844
Patent: CRYSTALLINE NALOXOL-PEG CONJUGATE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 62643
Estimated Expiration: ⤷ Sign Up
Patent: 19305
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 18088
Estimated Expiration: ⤷ Sign Up
Patent: 1307356
Patent: Crystalline naloxol-PEG conjugate
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 2847
Patent: ОКСАЛАТНА СІЛЬ КОН'ЮГАТА mPEG7-O-НАЛОКСОЛУ (ВАРІАНТИ), СПОСІБ ЇЇ ОТРИМАННЯ (ВАРІАНТИ) ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 643
Patent: ?Conjugado cristalino de naloxol-PEG?.
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MOVANTIK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2569262 | ⤷ Sign Up | |
| Denmark | 1694363 | ⤷ Sign Up | |
| Mexico | PA04003597 | CONJUGADOS POLIMERICOS DE ANTAGONISTAS OPIACEOS. (POLYMER CONJUGATES OF OPIOID ANTAGONISTS.) | ⤷ Sign Up |
| Japan | 2013538849 | ⤷ Sign Up | |
| Hong Kong | 1215171 | ⤷ Sign Up | |
| Canada | 2549730 | PETITES MOLECULES CHIMIQUEMENT MODIFIEES (PEGYLATED SMALL MOLECULES) | ⤷ Sign Up |
| Slovenia | 1694363 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOVANTIK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1694363 | C01694363/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015 |
| 1694363 | C20150020 00290 | Estonia | ⤷ Sign Up | PRODUCT NAME: NALOKSEGOOL;REG NO/DATE: EU/1/14/962 10.12.2014 |
| 1694363 | 27/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| 1694363 | C300737 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208 |
| 1694363 | 1590027-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210 |
| 1694363 | CA 2015 00028 | Denmark | ⤷ Sign Up | PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208 |
| 1694363 | 592 | Finland | ⤷ Sign Up | |
| >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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