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Dow

Last Updated: May 22, 2022

NUZYRA Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Nuzyra

Nuzyra will be eligible for patent challenges on October 2, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NUZYRA
International Patents:234
US Patents:10
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 24
Clinical Trials: 5
Patent Applications: 157
Drug Prices: Drug price information for NUZYRA
What excipients (inactive ingredients) are in NUZYRA?NUZYRA excipients list
DailyMed Link:NUZYRA at DailyMed
Drug patent expirations by year for NUZYRA
Drug Prices for NUZYRA

See drug prices for NUZYRA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NUZYRA
Generic Entry Dates for NUZYRA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for NUZYRA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 NUZYRA

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

SponsorPhase
Paratek Pharmaceuticals IncPhase 3
Paratek Pharmaceuticals IncPhase 1
Hartford HospitalPhase 1

See all NUZYRA clinical trials

US Patents and Regulatory Information for NUZYRA

NUZYRA is protected by eleven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUZYRA is See Plans and Pricing.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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 NUZYRA

9-aminomethyl minocycline compounds and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION

Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION

9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA

9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA

Amino-methyl substituted tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

9-aminomethyl substituted minocycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

Oral and injectable formulations of tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

FDA Regulatory Exclusivity protecting NUZYRA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 NUZYRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 See Plans and Pricing See Plans and Pricing
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NUZYRA

When does loss-of-exclusivity occur for NUZYRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6001
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09229174
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0909211
Estimated Expiration: See Plans and Pricing

Patent: 2020011180
Estimated Expiration: See Plans and Pricing

Canada

Patent: 19751
Estimated Expiration: See Plans and Pricing

Patent: 84301
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10000281
Estimated Expiration: See Plans and Pricing

China

Patent: 2046177
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 00935
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180836
Estimated Expiration: See Plans and Pricing

Patent: 0201883
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20240
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010576
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

Patent: 89030
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 57928
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38257
Estimated Expiration: See Plans and Pricing

Patent: 52201
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8440
Estimated Expiration: See Plans and Pricing

Japan

Patent: 40119
Estimated Expiration: See Plans and Pricing

Patent: 12521
Estimated Expiration: See Plans and Pricing

Patent: 77645
Estimated Expiration: See Plans and Pricing

Patent: 11515473
Estimated Expiration: See Plans and Pricing

Patent: 14221820
Estimated Expiration: See Plans and Pricing

Patent: 16145260
Estimated Expiration: See Plans and Pricing

Patent: 18203778
Estimated Expiration: See Plans and Pricing

Patent: 19196408
Estimated Expiration: See Plans and Pricing

Patent: 21167355
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10010585
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 275
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8428
Estimated Expiration: See Plans and Pricing

Norway

Patent: 71348
Estimated Expiration: See Plans and Pricing

Poland

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 10144130
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 71348
Estimated Expiration: See Plans and Pricing

Patent: 48258
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1007013
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1746228
Estimated Expiration: See Plans and Pricing

Patent: 1835574
Estimated Expiration: See Plans and Pricing

Patent: 1893740
Estimated Expiration: See Plans and Pricing

Patent: 110008057
Estimated Expiration: See Plans and Pricing

Patent: 160105532
Estimated Expiration: See Plans and Pricing

Patent: 180026799
Estimated Expiration: See Plans and Pricing

Spain

Patent: 74708
Estimated Expiration: See Plans and Pricing

Patent: 36448
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000445
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1806893
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 9627
Estimated Expiration: See Plans and Pricing

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 NUZYRA around the world.

Country Patent Number Title Estimated Expiration
Taiwan I299038 See Plans and Pricing
Brazil PI0112269 composto de minociclina 9-aminometila substituída, e, composição farmacêutica See Plans and Pricing
Colombia 6300898 SALES Y POLIMORFOS DE 9-(2,2-DIMETIL-PROPIL-AMINOMETIL)-MINOCICLINA See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009120389 See Plans and Pricing
Poland 2271348 See Plans and Pricing
Denmark 2296464 See Plans and Pricing
Brazil PI0909211 formulação orais e injetáveis de composto de tetraciclina See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Boehringer Ingelheim
Baxter
Mallinckrodt
Dow

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.