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Last Updated: December 3, 2023

Omadacycline tosylate - Generic Drug Details


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What are the generic drug sources for omadacycline tosylate and what is the scope of freedom to operate?

Omadacycline tosylate is the generic ingredient in one branded drug marketed by Paratek Pharms Inc and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omadacycline tosylate has two hundred and forty-five patent family members in forty countries.

One supplier is listed for this compound.

Summary for omadacycline tosylate
International Patents:245
US Patents:10
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 12
DailyMed Link:omadacycline tosylate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for omadacycline tosylate
Generic Entry Dates for omadacycline tosylate*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for omadacycline tosylate*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for omadacycline tosylate

US Patents and Regulatory Information for omadacycline tosylate

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 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

Expired US Patents for omadacycline tosylate

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

International Patents for omadacycline tosylate

Country Patent Number Title Estimated Expiration
Ecuador SP10010576 FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA ⤷  Try a Trial
Russian Federation 2010144130 ПЕРОРАЛЬНАЯ И ИНЪЕКЦИОННАЯ КОМПОЗИЦИИ 9-[(2,2-ДИМЕТИЛПРОПИЛАМИНО)МЕТИЛ]МИНОЦИКЛИНА И СПОСОБ ПОЛУЧЕНИЯ ПЕРОРАЛЬНОЙ КОМПОЗИЦИИ ⤷  Try a Trial
Japan 2009029785 9-SUBSTITUTED MINOCYCLINE COMPOUND ⤷  Try a Trial
Brazil PI0909211 formulação orais e injetáveis de composto de tetraciclina ⤷  Try a Trial
Canada 2717703 COMPOSES DE MINOCYCLINE ET PROCEDES D'UTILISATION DE CEUX-CI (MINOCYCLINE COMPOUNDS AND METHODS OF USE THEREOF) ⤷  Try a Trial
South Korea 101093842 ⤷  Try a Trial
Brazil 112019001948 método de tratamento de um indivíduo humano. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Dow
Johnson and Johnson
Baxter
Merck

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.