Details for Patent: 10,124,014

Which drugs does patent 10,124,014 protect, and when does it expire?

Patent 10,124,014 protects NUZYRA and is included in two NDAs.

This patent has eleven patent family members in eleven countries.

Summary for Patent: 10,124,014

Title:	Minocycline compounds and methods of use thereof
Abstract:	Methods and compositions for using a tetracycline compound to treat bacterial infections are described. In one embodiment, for example, the invention provides a method of treating a subject for an infection, comprising administering to said subject an effective amount of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or a salt thereof, such that said subject is treated, wherein said infection is selected from the group consisting of MSSA, MRSA, B-streptococci, Viridans Streptococci, Enterococcus, or combinations thereof.
Inventor(s):	Sean M. Johnston, Robert D. Arbeit, Thomas J. Bigger, Dennis P. Molnar, S. Ken Tanaka
Assignee:	Paratek Pharmaceuticals Inc
Application Number:	US15/637,144
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,124,014
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

US Patent 10,124,014: Omadacycline Treatment Claims, Scope and Patent Landscape

US Patent 10,124,014 protects specific intravenous and IV-to-oral treatment regimens using omadacycline for complicated skin and skin structure infections, with mild gastrointestinal adverse events as a claim limitation. The patent is a method-of-treatment patent, not a basic composition patent. Its commercial relevance is tied to Nuzyra, the Paratek omadacycline product, and to generic products seeking approval for the same antibacterial indication.

The principal claim risk is highest for an IV omadacycline product used for approximately seven to 14 days, or for an IV lead-in of two to six days followed by oral omadacycline for a total treatment period of eight to 12 days.

What drug does US Patent 10,124,014 cover?

The claimed compound, 9-[(2,2-dimethyl-propylamino)-methyl]-minocycline, is omadacycline. Omadacycline is an aminomethylcycline antibiotic derived from minocycline and marketed in the United States as Nuzyra by Paratek Pharmaceuticals.

The patent covers the compound when used in a defined clinical treatment setting. It does not broadly claim every use of omadacycline, every dosage form, or every antibacterial indication.

Item	Data
Patent	US 10,124,014
Patent type	Method of treatment
Active ingredient	Omadacycline, including salts
Claimed disease	Complicated skin and skin structure infections
Administration	Intravenous administration; claim 2 also requires subsequent oral administration
Claimed adverse-event profile	Mild gastrointestinal adverse events
Claimed duration	Claim 1: up to and including approximately 7, 8, 9, 10, or 14 days; claim 2: IV for approximately 2-6 days and total treatment for approximately 8-12 days
Patent holder/associated innovator	Paratek Pharmaceuticals
Patent issue date	November 13, 2018
Nominal patent term endpoint	Approximately March 26, 2034, before any applicable patent-term adjustment

The exact statutory expiration date should be determined from the USPTO patent-term-adjustment record and any Orange Book listing. The nominal term is calculated from the relevant nonprovisional filing date, not necessarily from the earliest provisional priority date. (United States Patent No. 10,124,014, 2018.)

What does claim 1 of US 10,124,014 require?

Claim 1 requires all of the following:

1. A human subject.
2. Treatment for complicated skin and skin structure infections.
3. Intravenous administration.
4. An effective amount of omadacycline or a salt.
5. Treatment that results in the subject being treated.
6. Gastrointestinal adverse events associated with treatment that are mild.
7. Treatment for a period falling within one of the stated duration limitations.

The duration language is unusual because the claim recites several alternatives: up to and including about 14 days, 10 days, nine days, eight days, or seven days. Each alternative is a separate claim limitation pathway. A commercially relevant regimen that lasts seven days would fall within the seven-day alternative and also within broader alternatives stated as approximately eight, nine, 10, or 14 days only if the ordinary meaning and prosecution history support those overlapping constructions.

The claim does not state a specific milligram dose, loading regimen, infusion time, or dosing interval. That omission broadens the claim with respect to dose, but the claim remains limited by the infection type, IV route, treatment duration, and mild-GI-adverse-event limitation.

What does claim 2 of US 10,124,014 require?

Claim 2 covers an IV-to-oral switch regimen. It requires:

Limitation	Scope
Patient	Human subject
Disease	Complicated skin and skin structure infection
Drug	Omadacycline or a salt
Initial route	Intravenous
Later route	Oral administration
IV duration	Approximately 2-6 days
Total duration	Approximately 8-12 days
Safety condition	GI adverse events associated with treatment are mild

Claim 2 is narrower than claim 1 because it requires sequential administration. A product used only intravenously for the full course would not satisfy the IV-to-oral sequence in claim 2, although it could potentially implicate claim 1.

A regimen using three days of IV treatment followed by seven days of oral treatment presents a direct claim-2 issue because it fits the two-to-six-day IV window and the eight-to-12-day total-treatment window.

How strong is the patent scope?

The patent has meaningful commercial scope because it claims a clinically practical regimen rather than an experimental use. Its strength depends on whether an accused product or treatment protocol satisfies the mild-GI-adverse-event limitation and the duration language.

Strongest infringement scenarios

The strongest scenarios involve:

• Omadacycline administered IV for approximately seven to 14 days for an indicated skin infection.
• A two-to-six-day IV course followed by oral omadacycline.
• An eight-to-12-day total course.
• A label or clinical protocol that expressly identifies mild GI events as an expected treatment characteristic.
• A generic label that copies or relies on the Nuzyra skin-infection indication and IV-to-oral dosing instructions.

Potentially narrower enforcement issues

The following facts may create claim-construction or proof issues:

• The product is used for an infection outside the claimed complicated skin and skin structure indication.
• The regimen is materially shorter or longer than the stated periods.
• The accused use does not involve IV administration.
• GI adverse events are not mild, or the record does not establish that the claimed safety condition is met.
• The product label omits the patented method but physicians still use it for the patented indication.

The “mild” GI limitation is a clinical limitation rather than a simple formulation characteristic. Litigation would likely focus on how “mild” is measured, whether the limitation is assessed across the treated population or for the individual patient, and whether the prescribing information or clinical trial data establish the limitation.

What patents protect Nuzyra and omadacycline?

US 10,124,014 is one part of a broader Nuzyra patent estate. The estate has included patents directed to the omadacycline molecule, pharmaceutical compositions, formulations, dosage forms, and methods of use.

Protection category	Commercial function	Relevance to generic entry
Compound patents	Protect omadacycline and related aminomethylcycline structures	Core molecule protection
Salt and composition patents	Protect pharmaceutically acceptable forms and compositions	May limit alternative salt or formulation strategies
IV formulation patents	Protect injectable products and excipient systems	Relevant to injectable generic development
Oral formulation patents	Protect tablets or oral dosage forms	Relevant to oral generic substitution
Method-of-use patents	Protect treatment of specific infections and dosing regimens	Often asserted against ANDA applicants
Clinical-regimen patents	Protect IV duration, IV-to-oral switching, total course, or tolerability profile	Relevant to label-based or induced-infringement theories

The patent at issue is most important as a clinical-regimen patent. It does not replace the compound or formulation patents, but it can extend commercial protection beyond basic molecule claims.

What is the Orange Book status of US 10,124,014?

The FDA Orange Book is the principal source for approved-drug patent listings and certification dates for small-molecule ANDAs. Nuzyra is an approved small-molecule drug, so its patent disputes proceed through the Hatch-Waxman framework rather than the biosimilar pathway. The Orange Book listing must be reviewed by patent number and product presentation because a method patent may be listed against one or more approved indications or dosage forms. (U.S. Food and Drug Administration, n.d.-a.)

For an ANDA applicant, a listing of US 10,124,014 can create a Paragraph IV certification issue. The applicant would assert that the patent is invalid, unenforceable, or will not be infringed, unless it uses a permitted labeling strategy that omits the patented indication or regimen.

The listing is commercially important even if the compound patent expires earlier. A method patent can delay an unrestricted generic launch where the proposed label includes the patented skin-infection indication and regimen.

When does omadacycline lose exclusivity?

Omadacycline has several different exclusivity dates:

Exclusivity type	Relevance
New chemical entity exclusivity	Blocks ANDA approval for the statutory NCE period after FDA approval
Patent exclusivity	Depends on individual patent expiration and any PTA or PTE
Pediatric exclusivity	Adds six months to applicable regulatory exclusivities or patent terms when granted
Method-patent protection	May continue after basic molecule protection expires
Regulatory exclusivity for new indications	Depends on the FDA approval basis and statutory designation

Nuzyra received FDA approval in October 2018 for adults with acute bacterial skin and skin structure infections. The FDA later approved an oral and IV indication for community-acquired bacterial pneumonia. The product label identifies IV and oral dosing and permits transition from IV to oral administration in appropriate patients. (FDA, 2024.)

The nominal term endpoint associated with US 10,124,014 is approximately March 26, 2034, subject to the USPTO’s official patent-term calculation. That date is more relevant than the 2018 issue date because the patent term is generally measured from the applicable filing date.

What Paragraph IV challenges affect Nuzyra?

A generic company seeking approval for omadacycline could use one of four primary certification strategies:

1. Paragraph III certification, agreeing not to market until the relevant patent expires.
2. Paragraph IV certification, asserting that a listed patent is invalid, unenforceable, or not infringed.
3. A section viii statement, carving out a patented indication or method from the label.
4. A suitability or other abbreviated pathway where legally available.

For US 10,124,014, the key Paragraph IV questions are:

• Whether the proposed label includes complicated skin and skin structure infections.
• Whether the label includes IV therapy for the claimed duration.
• Whether it provides IV-to-oral switching.
• Whether the proposed regimen overlaps the two-to-six-day IV and eight-to-12-day total-course limitations.
• Whether the applicant can omit the patented method without removing a protected FDA-approved use.

A section viii carve-out could reduce literal label overlap, but it would not eliminate all potential inducement or contributory-infringement theories if the generic company promotes or facilitates the patented use.

No biosimilar analysis applies. Omadacycline is a chemically synthesized small molecule, and generic applicants would use the ANDA pathway rather than a 351(k) biosimilar application.

What patent litigation affects omadacycline generic entry?

The principal litigation risk is a Hatch-Waxman action filed after a Paragraph IV notice. A timely suit by the patent owner or NDA holder can trigger a 30-month stay of FDA approval under the governing statutory framework, subject to court and regulatory exceptions. (21 U.S.C. § 355.)

Potential defendants include generic companies developing IV and oral omadacycline products. The most important litigation issues would be:

• Claim construction of “mild” GI adverse events.
• Whether the claimed treatment period is indefinite or sufficiently definite.
• Whether “about” permits a commercial dosing period outside the literal numerical range.
• Written-description and enablement support for the clinical safety limitation.
• Obviousness based on known tetracycline treatment durations and IV-to-oral conversion.
• Infringement based on the proposed ANDA label.
• Availability of a valid section viii carve-out.

A generic company may challenge the patent without commercially launching immediately. The business outcome depends on settlement terms, the generic’s ability to carve out the indication, and the remaining compound and formulation patents.

How does US 10,124,014 compare with formulation patents?

Formulation patents and method patents create different risk profiles.

A formulation patent generally covers the product made by a generic manufacturer. Avoiding infringement may require a different excipient system, solid form, manufacturing process, or dosage form. A method patent instead focuses on how the product is used.

US 10,124,014 is potentially easier to design around at the protocol level than a compound patent. A manufacturer could attempt to avoid the claim by:

• Omitting the protected skin-infection indication.
• Omitting IV-to-oral instructions.
• Using a treatment duration outside the claimed range.
• Marketing only a nonprotected indication.

Those strategies may reduce regulatory or label-based infringement exposure but can also reduce the commercial value of the generic product.

What manufacturing and geographic barriers exist?

The patent does not claim the chemical manufacturing process for every production route to omadacycline. A company could therefore face no direct US 10,124,014 process-patent barrier while still facing:

• Compound or salt patents.
• Injectable formulation patents.
• Oral dosage-form patents.
• Drug-master-file confidentiality and technical-transfer barriers.
• FDA chemistry, manufacturing, and controls requirements.
• Foreign counterpart patents in Europe, Japan, Canada, and other markets.

Patent rights are territorial. A US judgment on US 10,124,014 does not determine infringement in Europe or other jurisdictions. Generic entry timing must be assessed separately by country, including national validation, supplementary protection certificates, pediatric extensions, and local regulatory exclusivity.

What is the commercial exposure from this patent?

Nuzyra’s exposure is concentrated in hospital and outpatient antibacterial markets. The patent matters most for:

• Hospital formularies using IV omadacycline.
• Patients transitioned from IV to oral therapy.
• Outpatient completion of an eight-to-12-day course.
• Generic products seeking both IV and oral approvals.
• Contracts that depend on an unrestricted label rather than a narrow carve-out.

A generic that obtains only an oral product or only a nonprotected indication would not have the same commercial substitution profile as an unrestricted IV-and-oral generic. The method patent therefore has greater strategic value when combined with formulation and product patents.

Key takeaways

• US 10,124,014 covers omadacycline treatment of complicated skin and skin structure infections.
• Claim 1 requires IV administration, mild GI adverse events, and a stated short-course duration.
• Claim 2 covers an IV-to-oral regimen with two to six IV days and an eight-to-12-day total course.
• The claims do not specify a particular dose, formulation, or infusion rate.
• The patent is a method-of-treatment asset, not the core chemical composition patent.
• Its nominal term runs to approximately March 26, 2034, subject to official USPTO term adjustments.
• A Paragraph IV challenger would likely attack the clinical limitation, obviousness, definiteness, written description, and label-based infringement.
• No biosimilar pathway applies because omadacycline is a small-molecule antibiotic.
• Generic risk is highest for a label that copies both IV treatment and IV-to-oral switching for the protected skin-infection use.

FAQs about US Patent 10,124,014

Does US 10,124,014 cover oral omadacycline by itself?

No. Claim 1 requires intravenous administration. Claim 2 requires initial IV administration followed by oral administration. Oral-only treatment is outside the express route limitations of these claims.

Does the patent cover all omadacycline infections?

No. The claims are directed to complicated skin and skin structure infections. They do not expressly cover every antibacterial indication, including pneumonia or other infections.

Can a generic avoid US 10,124,014 by changing the dose?

Possibly, but dose modification alone may not avoid infringement because the claims do not recite a specific dose. The generic would need to avoid another required limitation, such as the indication, route, duration, or IV-to-oral sequence.

Is “mild GI adverse events” a limitation that must be proved?

Yes. It is part of both claims. The patent owner would need to establish that the accused treatment produces or is associated with the claimed mild GI adverse-event profile under the applicable claim construction.

Is US 10,124,014 the only patent that can delay a generic Nuzyra launch?

No. Compound, formulation, dosage-form, and other method-of-use patents may create separate barriers. A generic must assess the complete Orange Book and patent estate, not this patent in isolation.

References

1. Food and Drug Administration. (2024). Nuzyra (omadacycline) prescribing information. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations, Orange Book. U.S. Department of Health and Human Services.

3. U.S. Patent No. 10,124,014. (2018). Methods of treating complicated skin and skin structure infections. United States Patent and Trademark Office.

4. 21 U.S.C. § 355. (2024). New drugs and antibiotic drugs. United States Code.

Drugs Protected by US Patent 10,124,014

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	10,124,014					TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	10,124,014					TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION

International Family Members for US Patent 10,124,014

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009220171
Brazil	PI0908951
Canada	2717703
Chile	2010000188
China	102015602
European Patent Office	2262754