US Patent 11,413,282: Venetoclax and Obinutuzumab Patent Scope, Expiration, and Generic Entry Risk
US Patent No. 11,413,282 protects a specific treatment regimen combining venetoclax, marketed as Venclexta, with obinutuzumab, marketed as Gazyva, for chronic lymphocytic leukemia. The patent is regimen-based rather than a basic compound patent. Its commercial importance comes from its alignment with the FDA-approved venetoclax-obinutuzumab schedule: six 28-day combination cycles, venetoclax dose ramp-up to 400 mg daily, obinutuzumab administration during the initial cycle and once per later cycle, followed by venetoclax monotherapy.
The patent was granted Aug. 9, 2022. Its listed expiration date is Sept. 15, 2035, before any applicable patent-term adjustment or extension reflected in official USPTO records. The patent creates a substantial method-of-use barrier for a generic venetoclax applicant seeking to market the labeled first-line CLL regimen, but it does not independently block all venetoclax products or every venetoclax-obinutuzumab treatment variation.
What drug does US Patent 11,413,282 protect?
The compound recited in claim 1 is venetoclax, a selective BCL-2 inhibitor.
| Item |
Information |
| Active ingredient |
Venetoclax |
| Brand |
Venclexta |
| Drug class |
BCL-2 inhibitor |
| Combination antibody |
Obinutuzumab, marketed as Gazyva |
| Disease |
Chronic lymphocytic leukemia |
| Patent |
US 11,413,282 |
| Grant date |
Aug. 9, 2022 |
| Listed expiration |
Sept. 15, 2035 |
| Claim type |
Method of treatment |
| Core regimen |
Venetoclax plus obinutuzumab, followed by venetoclax alone |
The lengthy chemical name in claim 1 identifies venetoclax by structure rather than by brand name or generic name. The claim therefore applies to administration of venetoclax even if a future product uses a different label, tablet appearance, manufacturer, or inactive-ingredient profile.
The patent does not claim obinutuzumab as a molecule. It claims the use of venetoclax and obinutuzumab together under a defined dosing schedule.
What are the essential elements of claim 1?
Claim 1 requires all of the following limitations:
- A human patient has CLL.
- The CLL is relapsed, refractory, or previously untreated.
- Venetoclax and obinutuzumab are co-administered.
- Treatment occurs in multiple 28-day dosing cycles.
- Obinutuzumab is administered weekly for at least two weeks during the first cycle.
- Obinutuzumab is administered once per cycle after the first cycle.
- Venetoclax is administered daily beginning in the first cycle.
- The venetoclax daily dose increases from a first amount to a higher second amount.
- After the combination phase, venetoclax is administered daily without obinutuzumab.
The claim uses “comprising.” That generally permits additional treatment components, such as supportive care or other agents, provided the claimed venetoclax-obinutuzumab regimen is still performed.
The final transition, “followed by administering ... the compound alone,” is commercially important. A treatment protocol that stops obinutuzumab after the combination cycles and continues venetoclax monotherapy can fall within the claim. The monotherapy phase is not an optional feature under the claim language.
How do claims 2 through 10 narrow the patent scope?
| Claim |
Added limitation |
Commercial effect |
| 1 |
Core venetoclax-obinutuzumab regimen |
Broadest independent regimen claim |
| 2 |
First obinutuzumab dose split between days 1 and 2 |
Tracks the initial divided antibody dose |
| 3 |
Venetoclax starts after first obinutuzumab administration |
Narrows treatment sequencing |
| 4 |
First venetoclax dose: 10-80 mg; later dose: 190-400 mg |
Captures dose ramp-up |
| 5 |
Obinutuzumab dose: 500-3,000 mg |
Broad antibody dose range |
| 6 |
Combination continues for six cycles |
Tracks the principal labeled regimen |
| 7 |
Second venetoclax dose is 400 mg |
Captures the standard maintenance dose |
| 8 |
Obinutuzumab dose is 1,000 mg |
Captures standard labeled antibody dosing |
| 9 |
Six cycles at 400 mg venetoclax and 1,000 mg obinutuzumab |
Narrow, high-value regimen claim |
| 10 |
CLL expresses CD20 |
Adds a biological disease limitation |
Claim 9 is likely the most commercially relevant dependent claim because it combines the standard 400 mg venetoclax dose, 1,000 mg obinutuzumab dose, and six-cycle combination period.
Does the patented regimen match the FDA-approved CLL schedule?
Yes. The claim architecture corresponds closely to the FDA-approved Venclexta-Gazyva regimen for previously untreated CLL.
Under the approved schedule, obinutuzumab is administered in cycle 1 on days 1, 2, 8, and 15, then on day 1 of cycles 2 through 6. Venetoclax begins during cycle 1 after initial obinutuzumab administration and follows a ramp-up schedule that reaches 400 mg daily. Venetoclax then continues as monotherapy after completion of the six combination cycles. The FDA prescribing information describes the regimen and dose escalation requirements. [1]
The principal label-aligned sequence is:
| Treatment period |
Venetoclax |
Obinutuzumab |
| Cycle 1, initial period |
Dose ramp-up beginning after initial antibody administration |
Divided initial administration, then weekly dosing |
| Cycles 2-6 |
Escalates to and continues at 400 mg daily |
Once on day 1 of each cycle |
| After cycle 6 |
Daily monotherapy |
Discontinued |
Claims 2, 3, 7, 8, and 9 are particularly close to this labeled schedule. A generic applicant seeking approval for the same CLL indication could face an induced-infringement or divided-infringement theory if its labeling instructs physicians to perform the patented steps.
When does US Patent 11,413,282 lose exclusivity?
The listed patent expiration date is Sept. 15, 2035. That date is distinct from FDA regulatory exclusivity.
| Exclusivity category |
Relevant date or period |
| US 11,413,282 patent term |
Listed expiration: Sept. 15, 2035 |
| Venclexta approval |
2016 |
| Obinutuzumab initial US approval |
2013 |
| Small-molecule generic pathway |
ANDA under Hatch-Waxman |
| Antibody competition |
BLA and biosimilar pathway under the BPCIA |
The patent is a method-of-use patent. Its expiration does not necessarily terminate every patent covering venetoclax. Separate compound, formulation, solid-state, crystalline-form, manufacturing, and other method-of-use patents may have different expiration dates.
A patent-term extension or adjustment can alter the effective enforceable term. The controlling date is the term displayed in the USPTO patent record and, for Orange Book-listed patents, the FDA listing.
What is the Orange Book status of US 11,413,282?
US 11,413,282 has been associated with the Venclexta patent estate and is relevant to the Orange Book-listed method-of-use protection for venetoclax. The FDA Orange Book identifies patents submitted by the NDA holder and patent-use codes associated with approved products. [2]
An Orange Book listing does not mean that every Venclexta use is blocked until 2035. Its effect depends on:
- the patent-use code;
- the ANDA applicant’s proposed label;
- whether the applicant certifies that the patent is invalid, unenforceable, or not infringed;
- whether the NDA holder files a timely infringement action;
- whether the approved generic label omits the patented use.
For a generic applicant, a Paragraph IV certification against this patent could trigger Hatch-Waxman litigation. A section viii statement may be available if the applicant can carve out the patented CLL regimen and retain approval for noncovered uses. The commercial value of that strategy depends on how much of the venetoclax market is represented by the obinutuzumab combination.
What Paragraph IV challenges and litigation risks apply?
A generic venetoclax applicant pursuing the CLL indication would face a potential Paragraph IV challenge to US 11,413,282. The relevant defenses would include:
Non-infringement
The applicant could argue that its proposed labeling does not instruct:
- six 28-day cycles;
- the specified obinutuzumab sequence;
- venetoclax initiation after the first antibody administration;
- dose escalation to 400 mg;
- post-combination venetoclax monotherapy.
This defense becomes difficult if the generic label copies the FDA-approved Venclexta-Gazyva schedule.
Invalidity
Potential invalidity theories could target:
- lack of written description for the full dosing permutations;
- lack of enablement across the claimed dose ranges;
- obviousness based on venetoclax monotherapy, obinutuzumab, and clinical combination data;
- indefiniteness involving “effective amount,” “multiple dosing cycles,” or “after the first dosing cycle.”
The claim’s close correspondence to the clinical regimen can support written-description and enablement defenses for the narrower claims. The same correspondence can support the patent owner’s infringement case against a label that instructs the identical regimen.
Divided infringement
Because the regimen involves a physician, patient, and two products, a generic applicant may contest whether all steps are attributable to one actor. The patent owner could respond that prescribing information actively encourages performance of the full regimen and that the treating physician directs the relevant steps.
Settlement risk
A settlement could establish a licensed entry date before Sept. 15, 2035. Any agreement between a branded sponsor and a first-filing generic applicant may require Federal Trade Commission and Department of Justice review under applicable pharmaceutical patent-settlement reporting rules. The patent number alone does not establish the existence or terms of a settlement agreement.
How strong is the patent estate for venetoclax?
The venetoclax estate has multiple protection layers, but US 11,413,282 is narrower than the foundational compound patents.
| Protection layer |
Function |
Relevance of US 11,413,282 |
| Compound patents |
Protect venetoclax itself |
Separate from this patent |
| Solid-form and formulation patents |
Protect physical form, tablets, or dosage compositions |
Separate potential barriers |
| Manufacturing patents |
Protect synthesis or process steps |
May restrict supply, not necessarily sale |
| Method-of-use patents |
Protect disease and regimen uses |
US 11,413,282 is in this category |
| Combination patents |
Protect venetoclax with antibody therapy |
This patent covers a defined combination regimen |
| Regulatory exclusivity |
Limits approval pathways for a period |
Separate from patent rights |
The patent is strongest against a generic label that directly reproduces the FDA-approved venetoclax-obinutuzumab schedule. It is weaker against:
- venetoclax monotherapy;
- use in diseases outside CLL;
- combination with an anti-CD20 antibody other than obinutuzumab;
- regimens with materially different cycle lengths;
- regimens that omit the required post-combination monotherapy;
- treatment protocols that do not perform the claimed dose escalation.
The patent does not cover a generic venetoclax product merely because the product contains venetoclax. Infringement depends on the approved use, label instructions, and actual treatment conduct.
What formulations are protected by this patent?
US 11,413,282 does not claim a particular tablet formulation, excipient system, coating, crystalline form, particle-size distribution, or manufacturing process. Its claims are directed to administration of venetoclax and obinutuzumab.
A competing venetoclax formulation could still infringe if it is used according to the claimed regimen. Conversely, a formulation patent could create a separate barrier even if a proposed regimen falls outside US 11,413,282.
This distinction matters for generic strategy. An ANDA applicant must analyze both:
- product and formulation patents listed for Venclexta; and
- method-of-use patents covering proposed indications and dosing instructions.
Does the patent create biosimilar risk for obinutuzumab?
No direct biosimilar claim arises from this patent because the patent does not claim obinutuzumab as a biologic molecule. It claims a method using obinutuzumab with venetoclax.
An obinutuzumab biosimilar applicant could face separate BPCIA patent litigation involving:
- the antibody sequence;
- cell-line and production methods;
- formulation;
- dosing;
- treatment methods;
- interchangeability or substitution.
A biosimilar label that includes the venetoclax combination regimen could create exposure under US 11,413,282 even if the biosimilar avoids separate composition claims. The practical risk is higher if the biosimilar label expressly reproduces the six-cycle CLL combination schedule.
Which companies are commercially exposed?
| Company |
Product or role |
Exposure |
| AbbVie |
Venclexta sponsor and venetoclax rights holder |
Primary patent and revenue exposure |
| Genentech/Roche |
Gazyva sponsor and development/commercial partner |
Exposure to obinutuzumab combination economics |
| Generic manufacturers |
Future venetoclax ANDA applicants |
Paragraph IV and label-carve-out risk |
| Biosimilar developers |
Potential obinutuzumab competitors |
Combination-method infringement risk |
AbbVie and Genentech/Roche developed venetoclax through a collaboration covering development and commercialization. The commercial arrangement supports the combination strategy but does not expand the literal scope of US 11,413,282 beyond its claims. [3]
What generic launch scenarios exist?
Scenario 1: Full-label generic entry after patent expiry
A generic applicant receives approval for the CLL indication and labels the product for the venetoclax-obinutuzumab regimen. Entry is delayed until patent expiry, litigation resolution, or a licensed settlement date.
Scenario 2: Carved-out label
The applicant removes the patented obinutuzumab combination use and seeks approval for other venetoclax indications or monotherapy. This could permit earlier entry but would limit the addressable market.
Scenario 3: Paragraph IV litigation
The applicant certifies that US 11,413,282 is invalid, unenforceable, or not infringed. A timely suit can impose a 30-month stay on FDA approval, subject to statutory exceptions and court developments.
Scenario 4: Non-infringing regimen
A competitor develops a regimen using different dosing, cycle structure, antibody, or treatment sequence. This approach must still be screened against other venetoclax and obinutuzumab patents.
What geographic coverage does US 11,413,282 provide?
The patent is enforceable only in the United States. It does not automatically protect the same regimen in Europe, Japan, Canada, China, or other markets.
International protection must be analyzed through the corresponding patent-family members. The scope, expiration, prosecution history, supplementary protection certificates, and national litigation outcomes may differ by country. European and other national rights may also be affected by unitary-patent procedures, local validation, and country-specific claim amendments.
Key Takeaways
- US 11,413,282 is a regimen patent for venetoclax plus obinutuzumab in CLL.
- The claimed compound is venetoclax, not a new molecular entity distinct from Venclexta.
- The patent closely tracks the FDA-approved six-cycle CLL combination regimen.
- The most commercially important limitations are dose ramp-up, 28-day cycles, obinutuzumab sequencing, 400 mg venetoclax dosing, and subsequent venetoclax monotherapy.
- The listed expiration date is Sept. 15, 2035.
- The patent does not independently block all venetoclax products, formulations, monotherapy uses, or non-CLL indications.
- A generic applicant copying the labeled venetoclax-obinutuzumab regimen faces Paragraph IV and induced-infringement risk.
- A section viii label carve-out may be commercially viable for noncovered indications, depending on the Orange Book patent-use code.
- Obinutuzumab biosimilar developers face a separate BPCIA landscape, but a combination label could implicate this patent.
- Patent risk must be assessed with the broader venetoclax compound, formulation, manufacturing, and method-of-use estate.
FAQs About US Patent 11,413,282
Is US 11,413,282 a venetoclax composition-of-matter patent?
No. It is a method-of-treatment patent. The claims cover administration of venetoclax with obinutuzumab under specified CLL dosing conditions.
Does US 11,413,282 cover venetoclax monotherapy?
Only in the context of the claimed sequence. The patent requires initial co-administration with obinutuzumab followed by venetoclax alone. Stand-alone venetoclax monotherapy is not independently claimed.
Can a generic venetoclax applicant avoid the patent by changing tablet excipients?
Not necessarily. The patent claims the treatment method, not the tablet composition. A different formulation may still infringe if used according to the claimed regimen.
Does the patent cover mantle cell lymphoma or acute myeloid leukemia?
The claims provided are directed to chronic lymphocytic leukemia. They do not expressly cover mantle cell lymphoma or acute myeloid leukemia.
What is the highest-risk claim for a Venclexta generic?
Claim 9 presents the clearest label-based risk because it combines six cycles, 400 mg venetoclax, 1,000 mg obinutuzumab, and the claimed combination regimen.
References
-
U.S. Food and Drug Administration. (2024). Venclexta (venetoclax) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208573s030lbl.pdf
-
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
-
AbbVie Inc. (2016). AbbVie announces FDA approval of Venclexta (venetoclax) for patients with chronic lymphocytic leukemia with 17p deletion. https://news.abbvie.com/
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United States Patent and Trademark Office. (2022). US Patent No. 11,413,282, patent grant and transaction history. https://patentcenter.uspto.gov/
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U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov/
