OMADACYCLINE TOSYLATE - Generic Drug Details

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What are the generic drug sources for omadacycline tosylate and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for OMADACYCLINE TOSYLATE

International Patents:	250
US Patents:	9
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW Dosage: POWDER;INTRAVENOUS
Generic Entry Dates for OMADACYCLINE TOSYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Drug Class	Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for OMADACYCLINE TOSYLATE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for OMADACYCLINE TOSYLATE

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Glossary

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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	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 OMADACYCLINE TOSYLATE

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

International Patents for OMADACYCLINE TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Spain	2836448		⤷ Sign Up
Australia	2005201623	9-substituted minocycline compounds	⤷ Sign Up
Japan	2019196408	テトラサイクリン化合物の経口製剤および注射可能な製剤 (ORAL AND INJECTABLE FORMULATION OF TETRACYCLINE COMPOUND)	⤷ Sign Up
Russian Federation	2010152758	КРИСТАЛЛИЧЕСКАЯ ФОРМА И ТОЗИЛАТ СОЕДИНЕНИЯ ТЕТРАЦИКЛИНА, КРИСТАЛЛИЧЕСКАЯ ФОРМА УКАЗАННОГО ТОЗИЛАТА И ЕЕ ПОЛИМОРФНАЯ МОДИФИКАЦИЯ, СПОСОБ ПОЛУЧЕНИЯ ТОЗИЛАТА СОЕДИНЕНИЯ ТЕТРАЦИКЛИНА, ПОЛИМОРФНАЯ МОДИФИКАЦИЯ, ПОЛУЧЕННАЯ УКАЗАННЫМ СПОСОБОМ, И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ НА ОСНОВЕ ВЫШЕУКАЗАННЫХ КРИСТАЛЛИЧЕСКОЙ ФОРМЫ И ПОЛИМОРФНОЙ МОДИФИКАЦИИ	⤷ Sign Up
Turkey	201806893		⤷ Sign Up
China	1649582	Amino-methyl substituted tetracycline compounds	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.

Summary for OMADACYCLINE TOSYLATE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMADACYCLINE TOSYLATE

Pharmacology for OMADACYCLINE TOSYLATE

Anatomical Therapeutic Chemical (ATC) Classes for OMADACYCLINE TOSYLATE

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMADACYCLINE TOSYLATE