United States Patent 7,919,625: Bosutinib Composition Claim, Scope, Expiration, and Generic Entry Risk

U.S. Patent No. 7,919,625 protects pharmaceutical compositions containing bosutinib, the CML drug marketed by Pfizer as Bosulif. The supplied independent claim is narrow as to the active ingredient but broad as to formulation: it covers a pharmaceutical composition containing a CML-inhibiting amount of bosutinib, without limiting the composition to a specific tablet, capsule, excipient, salt, dosage strength, or release profile.

The patent is part of the U.S. bosutinib patent estate. The principal commercial risk is an ANDA applicant asserting that its product does not infringe the composition claim, that the claim is invalid, or that the patent has expired. Because bosutinib is a small molecule, biosimilar rules do not apply. Generic entry proceeds through the abbreviated new drug application pathway under the Hatch-Waxman Act.

What drug and active ingredient does U.S. Patent 7,919,625 protect?

The claimed compound is bosutinib, also known as SKI-606. Its chemical name is:

4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile.

Item	Data
Generic name	Bosutinib
Brand	Bosulif
Sponsor	Pfizer
Drug class	Tyrosine kinase inhibitor
Primary approved use	Philadelphia chromosome-positive chronic myeloid leukemia
Main molecular targets	BCR-ABL and Src-family kinases
Dosage forms	Oral tablets
FDA approval	September 4, 2012
Patent at issue	U.S. Patent No. 7,919,625
Patent type	Pharmaceutical composition
Regulatory pathway	NDA, followed by ANDA for generic competition

Bosutinib is approved for adults with Philadelphia chromosome-positive chronic myeloid leukemia, including newly diagnosed and previously treated patients, subject to the indications and limitations in the FDA-approved labeling.[1]

What does claim 1 of U.S. Patent 7,919,625 cover?

Claim 1 recites:

A pharmaceutical composition comprising a CML inhibiting amount of the compound [bosutinib].

The claim has four operative elements:

A pharmaceutical composition must exist.
The composition must contain bosutinib.
The amount of bosutinib must inhibit CML.
The claim uses the open-ended transition “comprising.”

The claim does not expressly require a particular excipient, dosage form, manufacturing process, purity level, polymorph, particle size, coating, or release mechanism.

How broad is the “comprising” language?

“Comprising” generally permits the presence of additional ingredients. A composition containing bosutinib and conventional excipients can fall within the claim even if it also contains other active or inactive components, unless another claim limitation or a prosecution-history restriction narrows the scope.

The claim can therefore reach:

Immediate-release tablets containing bosutinib.
Capsules containing bosutinib.
Powdered or granulated oral compositions.
Compositions containing binders, diluents, lubricants, disintegrants, coatings, or stabilizers.
Compositions containing additional pharmaceutical ingredients, subject to other legal requirements.
Generic bosutinib tablets that use different excipients from Bosulif.

The claim is less likely to reach a product that contains no bosutinib, uses a chemically distinct derivative, or contains bosutinib in an amount that does not satisfy the functional CML-inhibition limitation.

What is the infringement scope of the bosutinib composition claim?

A generic applicant would typically face infringement risk if its proposed product contains bosutinib in a pharmaceutical dosage form. The commercial product need not copy Pfizer’s exact excipient system if the composition claim is interpreted as supplied.

Product characteristic	Likely relevance to claim 1
Same bosutinib molecule	Strongly supports infringement
Different tablet excipients	Usually does not avoid a broad composition claim
Different tablet strength	Does not necessarily avoid infringement
Immediate-release versus modified-release form	May matter only if another limitation applies
Bosutinib free base versus a claimed salt or formulation	Requires claim-construction analysis
No bosutinib in final dosage form	Avoids the literal active-ingredient limitation
Different kinase inhibitor	Avoids literal infringement
Bosutinib intermediate used during manufacturing but absent from product	Usually not direct infringement of the composition claim
Bosutinib made outside the United States and imported as tablets	Can create U.S. infringement exposure

The most important limitation is the requirement that the composition contain a “CML inhibiting amount.” A court would likely assess this limitation in view of the claim language, specification, prosecution history, pharmacology, and the amount of bosutinib present in the accused product.

For a finished generic tablet, the active ingredient is ordinarily present at a therapeutic level. That makes a noninfringement position based solely on the amount limitation difficult unless the applicant can show that the claimed functional requirement is not met or is indefinite.

What formulations are protected by U.S. Patent 7,919,625?

Based on the supplied claim, the patent protects the composition at the active-ingredient level rather than a narrowly defined formulation architecture.

The claim does not expressly require:

A specific dosage strength such as 100 mg, 400 mg, or 500 mg.
A particular excipient.
A coating.
A dissolution profile.
A particle-size distribution.
A polymorphic form.
A crystalline form.
A specific manufacturing process.
A specific route of administration.
A fixed dosing schedule.

This distinction matters. A separate formulation patent would normally identify technical features such as improved dissolution, reduced food effect, stability, controlled release, particle engineering, or a defined excipient combination. Claim 1, as supplied, does not contain those restrictions.

Does the claim cover Bosulif tablets?

A Bosulif tablet containing bosutinib is the clearest example of a composition within the claim. A generic tablet containing the same active ingredient would also present a substantial literal-infringement risk unless the generic applicant establishes a valid noninfringement or invalidity position.

The claim does not necessarily cover every product associated with bosutinib. It is directed to a pharmaceutical composition. A manufacturing intermediate, research reagent, or process stream may fall outside the claim if it is not a pharmaceutical composition containing a CML-inhibiting amount.

What is the patent expiration date for U.S. Patent 7,919,625?

The original patent term is calculated from the earliest effective U.S. nonprovisional filing date for the relevant patent family, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension.

Public FDA Orange Book information has associated the U.S. bosutinib patent estate, including U.S. Patent No. 7,919,625, with protection extending into December 2026.[2] The operative date for commercial planning is the Orange Book-listed expiration date and any applicable pediatric exclusivity period, not the nominal 20-year calculation alone.

Exclusivity component	Commercial significance
Patent term	Blocks infringing generic commercialization while enforceable
Patent-term adjustment	Can extend the nominal term for USPTO delay
Patent-term extension	May extend a qualifying patent for regulatory review time
Pediatric exclusivity	Can add six months to listed exclusivity if granted
New chemical entity exclusivity	Delays certain ANDA approvals but is separate from patent term
Orphan-drug exclusivity	Depends on the specific indication and designation

The September 2012 FDA approval triggered five-year new chemical entity exclusivity for bosutinib, subject to statutory exceptions. That exclusivity period is separate from the patent estate and did not itself determine the later patent expiration date.[1]

What is the Orange Book status of bosutinib?

The FDA Orange Book identifies patents and exclusivity associated with approved drug products. Bosulif is listed as a prescription drug product approved under an NDA, with U.S. patents associated with the product and its active ingredient or use.[2]

An Orange Book listing has practical importance because an ANDA applicant must address listed patents through one of four certifications:

Paragraph I: no patent information has been submitted.
Paragraph II: the patent has expired.
Paragraph III: the applicant will wait until patent expiration.
Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.

A Paragraph IV certification can trigger patent litigation if the NDA holder or patent owner files suit within the statutory period. The filing of suit can impose a 30-month stay on final ANDA approval, subject to statutory exceptions and court orders.[3]

Which companies are challenging bosutinib patents?

Generic companies can challenge bosutinib patents through ANDA Paragraph IV certifications. Public litigation and regulatory records should be reviewed for the specific applicant, patent, dosage strength, and litigation disposition because ANDA challenges may be filed confidentially until litigation begins or FDA approval becomes public.

The relevant competitive group consists of:

Pfizer, as the Bosulif sponsor and commercial patent holder or licensee.
Generic pharmaceutical companies filing ANDAs for bosutinib tablets.
Contract manufacturers supplying active pharmaceutical ingredient or finished dosage forms.
Potential purchasers of authorized-generic or settlement rights.

A Paragraph IV filer does not necessarily enter immediately. The case may end through:

Patent litigation and judgment.
A settlement with a negotiated launch date.
A license permitting earlier entry.
ANDA approval delayed until patent expiry.
A finding that the patent is invalid or not infringed.
Withdrawal or amendment of the certification.

What patent litigation affects bosutinib generic entry?

Bosutinib litigation risk centers on four issues:

Literal infringement

A generic product containing bosutinib in a pharmaceutical composition is the most direct infringement theory. The applicant may argue that its formulation does not satisfy a limitation in the asserted claim, but differences in excipients or tablet appearance generally have limited value against an open composition claim.

Validity

Potential invalidity grounds include:

Anticipation under 35 U.S.C. §102.
Obviousness under 35 U.S.C. §103.
Written-description or enablement defects under 35 U.S.C. §112.
Indefiniteness of the functional “CML inhibiting amount” limitation.
Double patenting.
Inequitable conduct, if supported by the record.

The obviousness inquiry would focus on prior-art quinoline kinase inhibitors, the motivation to select bosutinib’s substitution pattern, the expectation of CML activity, and any unexpected results.

Enforceability

Enforceability issues depend on prosecution conduct and the patent record. They cannot be inferred from the chemical structure alone.

Remedy and launch timing

If the patent is found valid and infringed, the court can impose an injunction or other relief. If the patent is invalid or not infringed, the generic applicant may receive approval subject to other Orange Book patents and regulatory requirements.

How strong is the patent estate for bosutinib?

The supplied composition claim is commercially significant because it targets the active pharmaceutical ingredient in a pharmaceutical composition. It does not depend on copying a specific commercial formulation.

Strengths

It identifies bosutinib by a precise chemical structure.
It reaches pharmaceutical compositions rather than only a particular brand formulation.
The “comprising” language permits additional excipients and ingredients.
A generic tablet ordinarily contains the same active ingredient in a therapeutic amount.
The claim aligns closely with the commercial product.

Vulnerabilities

The patent may face prior-art attacks involving related quinoline kinase inhibitors.
The functional phrase “CML inhibiting amount” may create claim-construction or definiteness disputes.
The claim does not expressly protect every manufacturing step.
Separate patent claims must be reviewed to determine whether salt, polymorph, formulation, method-of-use, or process protection exists.
Patent-term and terminal-disclaimer records can affect the effective expiration date.

The claim is stronger against ordinary bosutinib tablets than against alternative products that use a distinct active compound, a prodrug, or a product in which bosutinib is used only as an intermediate.

What generic launch scenarios exist for bosutinib?

Scenario	Effect on launch
No Paragraph IV challenge	Approval generally waits for patent and exclusivity barriers to clear
Paragraph III certification	Applicant accepts delayed approval until patent expiration
Paragraph IV with no suit	FDA approval may proceed after applicable statutory timing
Paragraph IV followed by timely suit	30-month stay may delay final approval
Settlement with licensed entry	Launch occurs on the negotiated date
Successful invalidity or noninfringement judgment	Earlier launch may become possible
Patent expiration	ANDA approval can proceed if regulatory requirements are satisfied
Authorized generic arrangement	Earlier commercial competition may occur without independent generic victory

A generic launch also requires FDA approval of the ANDA, satisfactory manufacturing controls, bioequivalence, labeling compliance, and resolution of all relevant Orange Book patents. Defeating or avoiding U.S. Patent 7,919,625 would not automatically clear every other bosutinib patent.

Does bosutinib have biosimilar risk?

No. Bosutinib is a chemically synthesized small-molecule drug, not a biological product. The relevant competitors are generic ANDA applicants, not biosimilar applicants under the Biologics Price Competition and Innovation Act.

The principal regulatory tests are pharmaceutical equivalence and bioequivalence. Generic applicants generally seek approval for the same active ingredient, route of administration, dosage form, strength, and conditions of use, subject to permissible differences under FDA rules.[3]

What manufacturing and geographic barriers remain?

The composition claim does not directly require a particular manufacturing method. A company can therefore face separate risks involving:

Bosutinib synthesis patents.
Intermediate and starting-material patents.
Polymorph or crystalline-form patents.
Process patents.
Formulation and stability patents.
Trade secrets concerning impurity control and scale-up.
API supplier qualification.
FDA current good manufacturing practice compliance.

U.S. patent protection applies to U.S. manufacture, use, sale, offer for sale, and importation. Foreign patents can restrict manufacture or sale in other jurisdictions but do not independently create U.S. infringement. A foreign-made bosutinib product imported into the United States can create U.S. exposure under the patent laws.

How does U.S. Patent 7,919,625 compare with other bosutinib protections?

Protection type	Typical subject matter	Relevance to generic entry
Composition patent	Bosutinib-containing pharmaceutical composition	Directly targets generic dosage forms
Compound patent	Bosutinib chemical structure	Protects the active ingredient itself
Method-of-use patent	Treatment of CML or related indications	Can create use-code and labeling issues
Formulation patent	Excipients, release, stability, or dissolution	May be avoided through formulation redesign
Process patent	Synthesis or purification	May affect API sourcing
Orange Book listing	FDA-recognized patent information	Determines ANDA certification obligations

The supplied claim is a composition claim. It should not be treated as proof that the patent independently covers every bosutinib use, synthesis route, salt, polymorph, or formulation. Those rights depend on separate claims in the patent family and related patents.

Key Takeaways

U.S. Patent 7,919,625 claims a pharmaceutical composition containing a CML-inhibiting amount of bosutinib.
The claim is broad as to excipients, dosage strength, and formulation architecture.
The open “comprising” language allows additional ingredients.
A conventional generic bosutinib tablet presents substantial infringement risk under the supplied claim.
Bosutinib is a small molecule, so generic competition proceeds through ANDA procedures rather than biosimilar procedures.
FDA approval occurred on September 4, 2012, and five-year new chemical entity exclusivity was separate from the patent term.
Public Orange Book information places the relevant bosutinib patent protection in the December 2026 period.
Generic entry depends on all listed patents, Paragraph IV litigation, settlements, FDA approval, and manufacturing compliance.
The claim does not by itself establish protection for bosutinib manufacturing methods, polymorphs, salts, or all methods of use.

FAQs

What is the chemical structure protected by U.S. Patent 7,919,625?

The patent claims bosutinib, a substituted quinoline compound with dichloromethoxyphenyl, methoxy, methylpiperazinylpropoxy, and nitrile substituents.

Can a generic company avoid claim 1 by changing the tablet excipients?

Usually not if the generic still contains bosutinib in a pharmaceutical composition and the amount is CML-inhibiting. Excipients generally do not remove the active ingredient from the claimed composition.

Does U.S. Patent 7,919,625 cover bosutinib API made outside the United States?

The supplied claim is directed to a pharmaceutical composition, not merely isolated API. Foreign manufacture can still create U.S. risk if the product is imported or sold in the United States, while separate process or compound claims may apply independently.

Is bosutinib subject to biosimilar competition?

No. Bosutinib is a small-molecule drug. Competition is expected through ANDA-approved generic tablets.

What is the most important legal issue for a Paragraph IV challenge?

The central issue is whether the proposed generic product contains bosutinib in a pharmaceutical composition satisfying the claim. Validity challenges would likely focus on obviousness, prior art, enablement, written description, and the functional “CML inhibiting amount” limitation.

References

U.S. Food and Drug Administration. (2012). Bosulif (bosutinib) prescribing information.
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Code, 21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.
U.S. Patent and Trademark Office. (2011). U.S. Patent No. 7,919,625, pharmaceutical composition containing bosutinib.
U.S. Code, 35 U.S.C. §§ 102, 103, 112, 156, and 271. Patentability, patent term extension, and infringement provisions.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003291245	⤷ Start Trial
Australia	2004289243	⤷ Start Trial
Brazil	PI0416289	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,919,625

Which drugs does patent 7,919,625 protect, and when does it expire?

Summary for Patent: 7,919,625