Details for Patent: 7,718,640

Which drugs does patent 7,718,640 protect, and when does it expire?

Patent 7,718,640 protects AVEED and is included in one NDA.

This patent has fifty-two patent family members in thirty-eight countries.

Summary for Patent: 7,718,640

Title:	Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
Abstract:	The present invention relates to pharmaceutical compositions, formulated for injectable administration, which comprises a testosterone ester, in particularly testosterone undecanoate, in a vehicle comprising castor oil and a co-solvent. Upon injecting the compositions according to a particular administration scheme, reliable levels of testosterone in serum in the normal physiological range is achieved for a long period. This allows for the use of the compositions in hormone replacement therapy and male contraception without concomitant monitoring of testosterone levels in serum by a physician.
Inventor(s):	Doris Hubler, Sabine Fricke, Jan-Peter Ingwersen, Wilhelm Kuhnz
Assignee:	Gruenenthal GmbH , Bayer Pharma AG
Application Number:	US10/798,780
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,718,640
Patent Claim Types: see list of patent claims	Composition;

United States Patent 7,718,640: Testosterone Undecanoate Injection Claims, Expiry, and Patent Landscape

US Patent 7,718,640 protects a specific long-acting testosterone undecanoate injection formulation. Its commercial relevance is strongest for products equivalent to Aveed, an intramuscular testosterone undecanoate product containing 750 mg in 3 mL, or 250 mg/mL, in a vehicle composed principally of castor oil and benzyl benzoate.

The patent does not broadly claim testosterone undecanoate, testosterone replacement therapy, or every injectable testosterone formulation. Its central limitation is the combination of:

• Testosterone undecanoate at 250 mg/mL;
• Intramuscular administration;
• A single-injection dosage form;
• Castor oil and benzyl benzoate as the vehicle;
• Castor oil at approximately 40% to 42% by volume in the core claim set.

The principal commercial product matching the claims is Aveed, marketed by Endo Pharmaceuticals under FDA NDA 021743.[2][3]

What does US Patent 7,718,640 protect?

The patent protects a formulation and dosage-form architecture rather than the testosterone undecanoate molecule itself.

Claim element	Scope
Active ingredient	Testosterone undecanoate
Concentration	250 mg/mL
Route	Intramuscular injection
Dosage form	Single-injection presentation
Vehicle	Castor oil plus benzyl benzoate
Core castor-oil range	40 to 42 vol%
Commercial dose	750 mg in 3 mL
Additional claimed dose	1,000 mg, corresponding to 4 mL at 250 mg/mL
Alternative castor-oil language	About 40 vol%
Exclusion	Certain claims exclude plant oils other than castor oil

The patent therefore targets a narrow but commercially important formulation. A competing product could avoid literal infringement by changing the active concentration, vehicle composition, route, dosage form, or excipient ratio. Each change would require a separate analysis under the patent’s claim language and the doctrine of equivalents.

How do the independent claims differ?

Claims 1 and 8 are the principal independent formulation claims.

Claim 1

Claim 1 requires:

1. A single-injection intramuscular composition;
2. Testosterone undecanoate at 250 mg/mL;
3. A vehicle containing castor oil and benzyl benzoate;
4. Castor oil at 40% to 42% by volume.

The phrase “containing” generally permits the presence of additional components unless the specification or prosecution history gives it a narrower meaning. Claim 6 narrows the vehicle by requiring that it consist of castor oil and benzyl benzoate.

Claim 8

Claim 8 covers a similar composition but uses “about 40 vol%” rather than the precise 40% to 42% range.

This wording can create a potentially broader numerical scope, depending on how “about” is construed in light of the specification, examples, analytical tolerances, and prosecution history. The two independent claims create overlapping protection around the commercial formulation.

Comparative scope

Issue	Claim 1	Claim 8
Testosterone undecanoate	250 mg/mL	250 mg/mL
Vehicle	Castor oil and benzyl benzoate	Castor oil and benzyl benzoate
Castor oil	40% to 42% vol	About 40% vol
Additional ingredients	Not expressly excluded	Not expressly excluded
Single-injection format	Required	Required
Intramuscular use	Required	Required

What do claims 2 through 7 cover?

Claims 2 through 7 narrow the formulation by specifying dose or vehicle composition.

Claim	Added limitation	Practical interpretation
2	750 mg testosterone undecanoate	At 250 mg/mL, generally a 3 mL dose
3	1,000 mg testosterone undecanoate	At 250 mg/mL, generally a 4 mL dose
4	25% to 30% castor oil	Creates a dependency and consistency issue
5	55% to 65% benzyl benzoate	Narrows excipient concentration
6	Vehicle consists of castor oil and benzyl benzoate	Excludes other vehicle components
7	Claim 2 vehicle consists of castor oil and benzyl benzoate	Dose-specific version of claim 6

Claim 2 closely corresponds to a 750 mg/3 mL product. Claim 3 corresponds to a 1,000 mg/4 mL product, although the commercial relevance of the 1,000 mg embodiment is less direct if the marketed product is the 750 mg dose.

Claim 5 is numerically compatible with the core vehicle. If castor oil is 40% to 42% and benzyl benzoate is 55% to 65%, the combined vehicle components may account for 95% to 107% by volume. The claim set therefore requires careful reading of whether the percentages refer to the total composition, the vehicle, or separate formulation calculations.

Is claim 4 internally inconsistent?

Yes. Based on the claim text supplied, claim 4 presents a material dependency problem.

Claim 4 depends on claim 2. Claim 2 depends on claim 1. Claim 1 requires castor oil at 40% to 42% by volume. Claim 4 then requires the vehicle to contain castor oil at 25% to 30% by volume.

A composition cannot simultaneously satisfy both ranges if the terms are measured on the same basis. The inconsistency may result from:

• A transcription error;
• An amendment or correction not reflected in the supplied text;
• A dependency error;
• Different references to the vehicle and total composition;
• A claim-construction issue resolved through the specification or prosecution history.

This issue affects claim validity, enforceability, and infringement analysis. Claim 4 should not be assessed in isolation. The issued patent, certificate of correction, prosecution history, and claim-construction record control.

What do claims 9 through 14 add?

Claims 9 through 14 repeat the 750 mg and 1,000 mg dosage limitations under the claim 8 formulation branch.

Claim	Added limitation
9	750 mg testosterone undecanoate under claim 8
10	1,000 mg testosterone undecanoate under claim 8
11	No plant oil other than castor oil
12	The same exclusion applied to the 750 mg embodiment
13	Vehicle consists of castor oil and benzyl benzoate
14	The same vehicle limitation applied to the 750 mg embodiment

Claims 11 and 12 are particularly relevant to formulation design-around analysis. A product using another plant oil, such as sesame, cottonseed, olive, or soybean oil, may avoid literal infringement of those claims. It could still implicate broader claims if it retains castor oil and benzyl benzoate within the claimed concentration and dosage structure.

What product most directly practices the patent?

Aveed is the principal product associated with the claimed formulation.

Product	Active ingredient	Strength	Dose	Route	Commercial sponsor
Aveed	Testosterone undecanoate	250 mg/mL	750 mg/3 mL	Deep intramuscular injection	Endo Pharmaceuticals

The FDA label identifies Aveed as a 750 mg/3 mL intramuscular injection and lists castor oil and benzyl benzoate among the inactive ingredients.[2] Those characteristics map closely to claims 1, 2, 5, 6, 8, 9, and 13.

The label also requires administration by a healthcare professional and post-injection observation because of the risk of pulmonary oil microembolism and anaphylaxis.[2] Those regulatory controls do not expand the patent claims, but they increase the commercial and manufacturing barriers for a competing injectable product.

When did US Patent 7,718,640 expire?

The patent’s original priority chain traces to the early 2000s. The effective US patent term is determined by the filing and priority record, statutory patent-term adjustment, and any applicable extensions.

Public patent and regulatory records have associated the patent with an expiration date in November 2024. The controlling date is the term recorded by the USPTO and, for an Orange Book-listed patent, the FDA’s current Orange Book entry.[1][3]

The relevant exclusivity timeline is:

Event	Approximate date
Earliest priority	2001
US patent issuance	May 18, 2010
Aveed FDA approval	March 2014
New chemical entity exclusivity	Not applicable to the active ingredient as a new chemical entity
Three-year approval-related exclusivity	Ran from the 2014 approval period
Expected patent expiry	November 2024

Testosterone undecanoate was not a new chemical entity when Aveed was approved. The commercial protection therefore depended principally on formulation patents, regulatory exclusivity, manufacturing know-how, and the difficulty of developing and approving a long-acting injectable alternative.

What is the Orange Book status of US Patent 7,718,640?

US Patent 7,718,640 has been associated with Aveed’s FDA-listed patent estate. An Orange Book listing does not establish infringement or validity. It identifies a patent that the NDA holder or applicant represented as relevant to the approved drug.

For an ANDA applicant, a listed patent can trigger:

• A Paragraph IV certification alleging that the patent is invalid, unenforceable, or not infringed;
• Notice to the patent owner and NDA holder;
• Potential Hatch-Waxman litigation;
• A 30-month stay of approval if litigation is timely initiated.

Because the patent’s expected term ended in 2024, its present blocking effect depends on the exact term, any patent-term extension, litigation history, and whether related patents remain listed.

Which companies could challenge the patent?

A company seeking to market a generic testosterone undecanoate injection would most likely use the ANDA pathway rather than the biosimilar pathway. Testosterone undecanoate is a small-molecule active ingredient, so a 351(k) biosimilar application is not the appropriate FDA route.

Potential ANDA strategies include:

1. Paragraph III certification, accepting delayed approval until patent expiry;
2. Paragraph IV certification, challenging validity or infringement;
3. A formulation design-around using a different oil or cosolvent;
4. A different concentration or injection volume;
5. A different dosage regimen or presentation;
6. A product relying on a non-infringing vehicle composition.

No public conclusion about a particular company’s Paragraph IV position should be drawn solely from the patent claims. An ANDA applicant’s certification and litigation record must be reviewed separately from the Orange Book listing.

What generic entry risks exist for an Aveed-like product?

The principal generic entry risk is formulation replication. The marketed 750 mg/3 mL product aligns with multiple claims:

• Claim 1: 250 mg/mL, castor oil/benzyl benzoate, 40% to 42% castor oil;
• Claim 2: 750 mg dose;
• Claim 5: benzyl benzoate at 55% to 65%;
• Claim 6: vehicle limited to castor oil and benzyl benzoate;
• Claim 8: approximately 40% castor oil;
• Claim 9: 750 mg dose;
• Claim 13: vehicle limited to the two named components.

A generic that duplicates the commercial formulation would face substantial literal-infringement exposure while the patent remains enforceable.

A design-around could use:

• A different oil system;
• A different benzyl benzoate concentration;
• A different testosterone undecanoate concentration;
• A formulation with additional vehicle components;
• A non-single-dose package;
• A different route, although that would no longer be therapeutically equivalent to the approved product.

The strongest design-around opportunities are likely excipient selection and concentration changes. The regulatory burden may be significant because changes in vehicle composition can affect particle size, depot formation, release kinetics, injection tolerability, sterility, and bioequivalence.

How strong is the patent estate?

US Patent 7,718,640 has high relevance to the commercial formulation but limited breadth outside that formulation.

Strength factor	Assessment
Product overlap	High for a 750 mg/3 mL formulation matching Aveed
Chemical composition breadth	Low to moderate
Dosage-form protection	Moderate
Manufacturing protection	Limited based on the supplied claims
Method-of-use protection	None apparent in the supplied claims
Route protection	High within intramuscular administration
Design-around potential	Moderate
Post-expiry blocking power	Low for this patent alone

The patent does not claim:

• A method of treating hypogonadism;
• A dosing interval;
• Patient selection;
• Pulmonary oil microembolism mitigation;
• Injection technique;
• A manufacturing process;
• A specific particle-size distribution;
• A sustained-release mechanism independent of the composition.

Those subjects may be covered by separate patents or regulatory exclusivity, but they are outside the supplied claim set.

What formulation patents and adjacent rights matter?

The relevant patent landscape has several layers.

Core formulation patent

US 7,718,640 is directed to the castor-oil and benzyl-benzoate vehicle at approximately 250 mg/mL testosterone undecanoate.

Regulatory exclusivity

Aveed’s approval created FDA exclusivity separate from patent protection. That exclusivity does not continue indefinitely and does not replace Orange Book patents.[2][3]

Manufacturing know-how

Long-acting injectable testosterone formulations require control over:

• Dissolution and mixing;
• Raw-material specifications;
• Sterility and particulate control;
• Fill-volume accuracy;
• Container closure integrity;
• Stability;
• Injection force;
• Depot behavior.

These manufacturing controls may remain commercially important after patent expiry even where they are not claimed in US 7,718,640.

Method-of-use patents

The supplied claims contain no method-of-use limitation. Separate patents could cover testosterone replacement regimens, patient populations, injection intervals, or risk-management procedures. Such patents would have to be analyzed independently and may be subject to different Orange Book use codes.

Geographic coverage

US 7,718,640 has US-only enforceability. Foreign counterparts, national-stage applications, and related continuation patents may have different claims, expiration dates, prosecution histories, and legal status. A US freedom-to-operate conclusion cannot be extended to Europe, Canada, Australia, Japan, or other markets without a jurisdiction-specific review.

Are there biosimilar risks?

No conventional biosimilar risk applies. Testosterone undecanoate is a chemically defined small molecule, and a competing product would generally proceed through an abbreviated new drug application or a full NDA pathway, not a biosimilar application.

The more relevant risk is generic or hybrid injectable competition. FDA approval would require pharmaceutical equivalence and appropriate evidence of bioequivalence, product quality, sterility, and injectable safety.

Are licensing deals relevant to claim scope?

Licensing does not change the meaning or enforceability of the patent claims. It can change who owns, controls, or enforces the rights.

Aveed’s commercial sponsor, NDA holder, patent owner, and manufacturing entity may be different legal entities. A transaction involving commercial rights does not by itself transfer patent title. The USPTO assignment record, FDA NDA record, and any publicly disclosed license or settlement agreement should be read together when assessing enforcement authority and royalty exposure.

What litigation and settlement issues should be reviewed?

The principal litigation trigger would be an ANDA Paragraph IV filing directed to an Aveed-like formulation. Relevant issues would include:

• Whether the accused product contains 250 mg/mL testosterone undecanoate;
• Whether its castor-oil concentration falls within 40% to 42% or “about 40%”;
• Whether benzyl benzoate is present at 55% to 65%;
• Whether the vehicle “consists of” only castor oil and benzyl benzoate;
• Whether the product is supplied as a single intramuscular injection;
• Whether claim 4’s inconsistent dependency affects enforceability;
• Whether prosecution history limits the numerical ranges;
• Whether any terminal disclaimer or patent-term adjustment changes expiry.

A settlement could permit an authorized generic, a licensed launch date, or a formulation-specific entry date. Settlement terms are often confidential, and a public absence of litigation does not establish freedom to launch.

Key Takeaways

• US Patent 7,718,640 is a narrow formulation patent centered on 250 mg/mL testosterone undecanoate in castor oil and benzyl benzoate.
• The 750 mg/3 mL Aveed formulation maps closely to several claims.
• Claims 1 and 8 are the principal independent claims.
• Claims 2, 5, 6, 9, and 13 are the most commercially relevant dependent claims for a standard Aveed-like product.
• Claim 4 contains an apparent internal inconsistency because it depends on a 40% to 42% castor-oil limitation while reciting 25% to 30%.
• The patent is not a molecule patent and does not claim all testosterone undecanoate products.
• Public records associate the patent with an expiration date in November 2024.
• Generic competition would proceed through the ANDA pathway, not the biosimilar pathway.
• Formulation design-around options exist but may create significant FDA, manufacturing, stability, and bioequivalence challenges.
• Any current launch or litigation assessment must include related patents, Orange Book records, assignments, prosecution history, and the exact patent-term calculation.

FAQs

Does US Patent 7,718,640 cover testosterone undecanoate capsules or oral products?

No. The supplied claims require a composition formulated for intramuscular injection. Oral testosterone undecanoate products fall outside these claims unless a separate claim set covers them.

Does changing the injection volume avoid the patent?

Not necessarily. A different volume alone may not avoid infringement if the product still contains 250 mg/mL testosterone undecanoate, uses the claimed vehicle, meets the castor-oil range, and is supplied as a single intramuscular injection.

Does using 41% castor oil create infringement risk?

Yes. Forty-one percent falls directly within the 40% to 42% range in claim 1 and is also likely within the “about 40 vol%” language of claim 8.

Would a formulation with 39% castor oil avoid all claims?

No definitive conclusion follows from the number alone. It may fall outside the literal 40% to 42% range, but claim 8, claim construction of “about,” prosecution history, and the doctrine of equivalents would remain relevant.

Can a generic manufacturer use the same active ingredient after patent expiry?

Once the patent has expired and no related enforceable patent or regulatory barrier blocks approval, the active ingredient may be used in an ANDA product. FDA requirements for pharmaceutical equivalence, bioequivalence, sterility, quality, and labeling remain applicable.

References

1. United States Patent and Trademark Office. (2010). US Patent No. 7,718,640, pharmaceutical composition containing testosterone undecanoate.
2. U.S. Food and Drug Administration. (2014). Aveed prescribing information. Endo Pharmaceuticals Inc.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book: Aveed, NDA 021743.

Drugs Protected by US Patent 7,718,640

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Endo Operations	AVEED	testosterone undecanoate	INJECTABLE;INTRAMUSCULAR	022219-001	Mar 5, 2014		RX	Yes	Yes			Y

International Family Members for US Patent 7,718,640

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	043603
Austria	336251
Australia	2004218893
Brazil	PI0400214
Canada	2518910