United States Patent 8,143,212: Dalbavancin Dosing Claims, Patent Scope and Generic Entry Risk

US Patent No. 8,143,212 protects selected dalbavancin dosing regimens for bacterial infections, particularly an initial dose followed by one or more lower subsequent doses administered five to 10 days later. The core commercial regimen for DALVANCE, 1,000 mg followed one week later by 500 mg, falls within the principal claim structure.

The patent does not broadly claim dalbavancin as a molecule, its chemical composition, or every method of treating infection. Its value is concentrated in dosing architecture: a larger loading dose, a defined dosing interval, and a subsequent dose that is no more than one-half of the initial dose. The patent’s projected ordinary term runs to approximately July 2026, subject to any applicable patent-term adjustment or terminal disclaimer. The FDA-approved dalbavancin regimen is also subject to other patents and regulatory protections, so expiration of US 8,143,212 would not necessarily create unrestricted generic launch rights.

What does US Patent 8,143,212 protect?

US 8,143,212 protects methods of treating a bacterial infection in a human by administering dalbavancin in an initial dose and one or more subsequent doses.

The independent claim requires all of the following:

Claim element	Requirement
Active ingredient	Dalbavancin
Patient	Human with a bacterial infection
Dosage form	Dalbavancin in a pharmaceutically acceptable carrier
Dosing structure	Initial dose followed by subsequent dose or doses
Interval	Each dose separated by five to 10 days
Initial dose	About 100 mg to about 5,000 mg
Dose relationship	Initial dose is at least approximately twice the amount in each subsequent dose

The claim is a method-of-use claim. It does not cover the manufacture, sale or composition of dalbavancin in the abstract. Infringement would generally require practice of every material limitation, including the dosing interval and the relative dose requirement.

The claim is broad in infection type. It covers bacterial infections generally, while dependent claim 6 narrows the method to skin and soft-tissue infections.

How do the individual claims differ?

Claims 1 through 16 create a layered dosing regimen covering both the approved DALVANCE schedule and alternative weekly dosing programs.

Claim	Scope
1	Broad two-stage or multistage regimen; five-to-10-day intervals; initial dose at least twice each subsequent dose
2	Claim 1 with one subsequent dose
3	One subsequent dose approximately one week after the initial dose, with no intervening dose
4	Claim 1 with multiple subsequent doses
5	Multiple subsequent doses at approximately one-week intervals, with no intervening doses
6	Bacterial infection limited to skin and soft-tissue infection
7	Initial dose of approximately 200 mg to 1,500 mg
8	Initial dose of approximately 1,000 mg
9	Initial dose of approximately 800 mg
10	Initial dose of approximately 500 mg
11	Subsequent dose of approximately 400 mg to 1,200 mg
12	Subsequent dose of approximately 500 mg
13	Subsequent dose of approximately 400 mg
14	Subsequent dose of approximately 250 mg
15	Subsequent dose of approximately 200 mg
16	Initial dose of approximately 1,000 mg and subsequent dose of approximately 250 mg

Claim 1 is the principal commercial claim. Claims 8 and 12, when read together with claim 1, cover the 1,000 mg initial dose and 500 mg subsequent dose used in the approved two-dose regimen.

Claim 3 is particularly important because it narrows the schedule to one subsequent dose approximately one week later. It is therefore directed to the two-dose commercial regimen rather than an indefinite weekly treatment course.

Claim 5 covers repeated weekly dosing. It requires multiple subsequent doses and excludes an intervening dalbavancin dose between the recited weekly administrations.

Claim 16 is narrower than the approved 1,000 mg/500 mg schedule. It covers a 1,000 mg initial dose followed by 250 mg subsequent doses. The 1,000 mg/500 mg regimen is covered by the broader combination of claims 1, 8 and 12, not by claim 16.

Does the patent cover the FDA-approved DALVANCE regimen?

Yes. The standard adult DALVANCE regimen is within the scope of the broad claim structure.

The FDA-approved adult dosing options are:

FDA regimen	Relationship to US 8,143,212
1,500 mg as a single intravenous dose	Does not satisfy the required initial-plus-subsequent-dose structure when administered alone
1,000 mg followed one week later by 500 mg	Falls within claim 1 and the narrower claims covering 1,000 mg initial and 500 mg subsequent dosing
Pediatric weight-based dosing	May or may not fall within the claims depending on actual dose amounts, interval and whether the initial dose is at least twice the subsequent dose

The 1,500 mg single-dose regimen alone is outside claim 1 because there is no subsequent dose. A 1,000 mg dose followed by 500 mg approximately one week later satisfies the quantitative relationship because the initial dose is two times the subsequent dose.

The label identifies dalbavancin as an intravenous lipoglycopeptide antibacterial indicated for acute bacterial skin and skin-structure infections, now commonly described under the FDA’s acute bacterial skin and skin-structure infection terminology.[2]

What claim terms create the main infringement issues?

“About”

The patent uses “about” for dose amounts and timing. That language creates flexibility around exact quantities but does not make every nearby regimen automatically infringing. The court would ordinarily assess the intrinsic evidence, specification, prosecution history and technical meaning of the term.

The strongest literal infringement cases are regimens close to the expressly stated amounts, such as:

1,000 mg followed by 500 mg;
800 mg followed by 400 mg;
500 mg followed by 250 mg;
1,000 mg followed by 250 mg.

A regimen of 1,000 mg followed by 600 mg would raise a separate issue. It may fall within the “about” range of a 500 mg subsequent dose, but the initial dose would not be at least approximately twice the subsequent dose if the court applies the ratio strictly.

“Five to ten days”

The interval limitation is central. A regimen administered after three days or 14 days presents a stronger noninfringement position than a regimen administered on day seven or day eight.

The patent separately uses “about one week” in claims 3 and 5. A schedule administered on day seven or day eight is the clearest target. A schedule at day five or day 10 may fall within claim 1 but not necessarily within the narrower “about one week” language, depending on construction.

“Therapeutically effective dose”

This limitation requires that the administered dose be therapeutically effective for the patient and infection. It is not a fixed numerical requirement, but the express dosage ranges and clinical context provide boundaries.

“Pharmaceutically acceptable carrier”

This limitation is generally satisfied by the approved intravenous formulation and conventional pharmaceutical excipients. It is unlikely to be the primary barrier to a generic product using the same intravenous route and formulation architecture.

What is the patent term and exclusivity timeline?

The relevant timeline is:

Event	Date or period
Earliest priority associated with the claimed dosing technology	July 2005
US filing period	2006
Patent issued	March 27, 2012
Patent number	US 8,143,212 B2
Dalvance FDA approval	May 23, 2014
Original NCE exclusivity period	Approximately through May 2019
QIDP-related exclusivity framework	Potential five-year extension under the Generating Antibiotic Incentives Now Act
Projected ordinary patent expiration	Approximately July 2026
Potential pediatric extension	Six months, if statutory requirements were satisfied and the extension attached to the relevant protection

The patent term for a modern US utility patent generally runs 20 years from the earliest effective nonprovisional US filing date, subject to patent-term adjustment, patent-term extension and terminal-disclaimer limitations.[3] The expected July 2026 date should therefore be treated as the ordinary projected expiration date rather than an unconditional launch date.

Dalbavancin received qualified infectious disease product treatment under the GAIN Act framework. A QIDP designation can add five years to certain exclusivity or patent-term periods, but the extension operates within statutory limits and does not necessarily extend every patent or every listed claim.[4]

What is the Orange Book status of US 8,143,212?

US 8,143,212 is associated with the DALVANCE patent estate and has been treated as a method-of-use patent relevant to the product’s labeled dosing regimen. The FDA Orange Book is the controlling source for current listed patents, expiration dates and use codes.[1]

Orange Book relevance depends on three questions:

Whether US 8,143,212 remains listed against the current NDA.
Which use code is associated with the patent.
Whether a proposed ANDA label includes the patented dosing method.

An ANDA applicant seeking approval for a regimen covered by an Orange Book-listed method-of-use patent may submit a Paragraph IV certification. If the NDA holder or patent owner brings suit within 45 days, FDA approval may be stayed for up to 30 months, subject to statutory exceptions and litigation outcomes.[5]

A generic applicant may seek to avoid the patent through:

A Paragraph III certification accepting approval after patent expiration.
A Paragraph IV certification asserting invalidity or noninfringement.
A Section viii statement carving out the patented method from the proposed label.
A label limited to a noncovered regimen, if FDA permits the carve-out.

For dalbavancin, a Section viii strategy is difficult if the proposed generic label includes the principal 1,000 mg/500 mg two-dose regimen. A single-dose-only label could present a stronger carve-out theory against this patent, although other patents and FDA labeling requirements would remain relevant.

Which dalbavancin patents are relevant to generic entry?

The commercial patent estate is broader than US 8,143,212. Relevant categories include:

Patent category	Commercial significance
Dosing-regimen patents	Protect loading-dose and weekly-dose schedules
Composition and formulation patents	May cover dalbavancin formulations, excipients, stability or administration
Manufacturing patents	Can restrict production routes, intermediates or purification methods
Method-of-use patents	May cover skin infections, dosing schedules or other bacterial infections
Later patent continuations or divisionals	May preserve narrower claims after earlier claims expire or are challenged

Publicly associated DALVANCE patent records have included US 8,143,212 and later patents such as US 8,765,683 and US 9,266,951. Their relevance depends on the claims, listing status, use codes and current expiration dates. A complete freedom-to-operate conclusion requires reviewing the current FDA Orange Book, the USPTO maintenance and assignment records, issued claim sets, terminal disclaimers and any court judgments.

The principal technical barriers for a generic manufacturer are not limited to the active ingredient. They include:

Reproducing a sterile intravenous product;
Controlling dalbavancin purity and impurity profiles;
Demonstrating stability and container compatibility;
Establishing bioequivalence or the applicable pharmaceutical equivalence pathway;
Avoiding listed formulation and dosing claims;
Designing an acceptable label if a patented use is carved out.

How strong is the patent estate for the 1,000 mg/500 mg regimen?

The estate is strongest against a generic that seeks the full FDA adult label, including the two-dose regimen.

The claim coverage is commercially direct:

Claim 1 captures the overall loading-dose structure.
Claim 3 captures a single subsequent dose approximately one week later.
Claim 8 identifies the 1,000 mg initial dose.
Claim 12 identifies the 500 mg subsequent dose.
The dependent-claim combination maps closely to the labeled regimen.

The estate is weaker against:

A single 1,500 mg dose with no subsequent dose;
Regimens outside the five-to-10-day interval;
Dosing schedules where the initial dose is less than twice the subsequent dose;
A legally effective skinny label that excludes the patented dosing method;
A challenge based on anticipation, obviousness, written description or enablement.

The quantitative limits also create potential validity and construction disputes. Earlier dalbavancin clinical protocols, pharmacokinetic publications and patent applications would be central to any anticipation or obviousness challenge. A challenger would likely focus on whether the loading-dose and weekly-dose concept was predictable from dalbavancin’s long half-life and prior glycopeptide dosing data.

When does dalbavancin lose exclusivity?

Dalbavancin does not have one single exclusivity date.

Protection	General impact
FDA NCE exclusivity	Initially restricted ANDA filing for five years from approval, subject to statutory exceptions
QIDP exclusivity	Can add five years to qualifying exclusivity or patent protection
Pediatric exclusivity	Can add six months to qualifying protections
US 8,143,212	Projected to expire around July 2026, subject to adjustment or extension
Other listed patents	May expire later and independently delay or complicate generic launch
Litigation stay	May delay approval for up to 30 months after a timely Paragraph IV suit

The commercial loss-of-exclusivity date therefore depends on the latest enforceable patent or regulatory protection covering the proposed generic product and label. Expiration of US 8,143,212 alone does not eliminate later formulation, manufacturing or method patents.

Which companies are challenging dalbavancin exclusivity?

Generic competition is expected to focus on ANDA applicants seeking approval for dalbavancin injection. Public patent disputes involving the DALVANCE estate have included challenges associated with generic pharmaceutical companies, including Sun Pharmaceutical Industries and other potential ANDA applicants.

The key diligence point is the applicant’s proposed label. A company seeking the full two-dose regimen faces greater exposure under US 8,143,212 than an applicant pursuing only the 1,500 mg single-dose regimen or a legally approved carved-out label.

A definitive current challenger list requires the latest ANDA litigation docket, FDA Paragraph IV notice records, Orange Book data and court filings. The patent number alone does not identify every active dispute.

What litigation and settlement issues affect generic launch?

A Paragraph IV case involving US 8,143,212 would likely address:

Claim construction for “about,” “approximately one week” and “at least about two times.”
Whether the proposed product label induces use of the claimed regimen.
Anticipation by prior dalbavancin dosing disclosures.
Obviousness based on dalbavancin pharmacokinetics and prior weekly dosing.
Written-description support for the full dose and interval ranges.
Whether a generic label carve-out would remove the claimed use.
Whether later-listed patents independently block launch.

Settlement structures could include a date-certain launch, a license with royalties, a covenant not to sue, or a restriction to a noninfringing dosing label. A settlement involving this patent would not necessarily resolve later patents in the same estate.

How does US 8,143,212 compare with competing antibiotic patent estates?

Dalbavancin’s principal differentiation is the possibility of single-dose or once-weekly intravenous treatment. That dosing convenience creates a direct method-of-use patent opportunity.

Product	Core commercial dosing concept	Patent-risk profile
DALVANCE, dalbavancin	Single 1,500 mg dose or 1,000 mg plus 500 mg one week later	Strong exposure for full two-dose label under US 8,143,212 and related patents
ORBACTIV, oritavancin	Single intravenous dose for acute bacterial skin infections	More concentrated single-dose composition and use issues
VIBATIV, telavancin	Repeated intravenous dosing, generally daily	Different dosing architecture; less direct overlap with weekly dalbavancin claims
Long-acting lipoglycopeptide generics	Product-specific dosing and formulation	Manufacturing, formulation and regulatory barriers remain material

The claims of US 8,143,212 are unlikely to cover competing molecules such as oritavancin or telavancin because they expressly require dalbavancin.

What is the revenue exposure from this patent?

The principal revenue exposure is the adult acute bacterial skin and skin-structure infection market using the 1,000 mg/500 mg regimen. The patent has less direct relevance to sales based exclusively on the 1,500 mg single-dose option, although other patents may cover that product and its formulation.

Commercial erosion risk is likely to develop in stages:

Paragraph IV filing and litigation disclosure.
Settlement or court decision.
Potential launch of a generic with a restricted label.
Broader erosion after the last relevant formulation, manufacturing and method patents expire.
Price compression if multiple injectable suppliers enter.

A generic with the complete two-dose label would have the broadest market opportunity but the highest infringement exposure. A single-dose or skinny-label product could enter with narrower market access and lower exposure under this patent.

Key Takeaways

US 8,143,212 is a dalbavancin dosing-regimen patent, not a molecule patent.
Claim 1 requires an initial dose, a subsequent dose, a five-to-10-day interval and an initial dose at least approximately twice the subsequent dose.
The FDA-approved 1,000 mg followed one week later by 500 mg regimen falls within the claim structure.
The 1,500 mg single-dose regimen, standing alone, does not satisfy the initial-plus-subsequent-dose limitation.
Claims 3, 8 and 12 provide particularly direct coverage of the commercial two-dose regimen.
The patent’s ordinary projected expiration is approximately July 2026, subject to patent-term adjustment, extensions and terminal disclaimers.
FDA exclusivity, QIDP protection, pediatric exclusivity and other Orange Book patents must be analyzed separately.
A Paragraph IV challenge would likely focus on obviousness, prior-art dosing disclosures, claim construction and label-induced infringement.
A generic using the full adult DALVANCE label faces greater risk than one limited to the single-dose regimen.
Formulation, manufacturing and later method patents may continue to restrict generic entry after US 8,143,212 expires.

FAQs About US Patent 8,143,212 and Dalbavancin

Does US 8,143,212 cover a 1,500 mg single dose of dalbavancin?

Not by itself when no subsequent dose is administered. The independent claim requires an initial dose and at least one subsequent dose.

Does a 1,000 mg dose followed by 500 mg seven days later infringe the patent?

That regimen falls within the express structure of claim 1 and the dependent-claim combinations covering a 1,000 mg initial dose and 500 mg subsequent dose, subject to claim construction and patent validity.

Can a generic launch with only the single-dose dalbavancin regimen?

Potentially, but the strategy depends on FDA approval of the carved-out label and the absence of blocking composition, formulation, manufacturing or other method patents.

What is the main validity vulnerability of US 8,143,212?

The principal potential vulnerabilities are obviousness and anticipation based on prior dalbavancin pharmacokinetic data, long-half-life properties and earlier loading-dose or weekly-dose disclosures.

Does expiration of US 8,143,212 guarantee generic dalbavancin entry?

No. Other Orange Book-listed patents, unlisted manufacturing rights, regulatory requirements and product-specific formulation claims may independently affect launch timing.

References

U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2024). DALVANCE (dalbavancin) prescribing information.
United States Patent and Trademark Office. (2025). Patent term adjustment and patent term calculation guidance.
Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, § 801, 126 Stat. 993 (2012).
21 U.S.C. § 355(j)(2)(A)(vii)-(viii); 21 U.S.C. § 355(j)(5)(B)(iii).
U.S. Patent No. 8,143,212 B2. (2012). Methods for treating bacterial infections. United States Patent and Trademark Office.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003294262	⤷ Start Trial
Australia	2003298662	⤷ Start Trial
Australia	2003299561	⤷ Start Trial
Australia	2005325261	⤷ Start Trial
Australia	2011200423	⤷ Start Trial
Brazil	PI0510269	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,143,212

Summary for Patent: 8,143,212