Details for Patent: 9,855,335

Which drugs does patent 9,855,335 protect, and when does it expire?

Patent 9,855,335 protects TIGECYCLINE and is included in one NDA.

This patent has eight patent family members in eight countries.

Summary for Patent: 9,855,335

Title:	Tigecycline composition for injection
Abstract:	Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation. Compared to the compositions currently in clinical use, the composition of the present invention can increase the treatment effect of tigecycline, avoid safety risks caused by lactose, is easy to produce and store, and has a clinical usage stability, satisfying the requirements for clinical medicine.
Inventor(s):	Jihong Quin
Assignee:	Galenicum Health SL
Application Number:	US14/413,854
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

US Patent 9,855,335: Tigecycline Injectable Formulation Claims, Scope, Expiration and Patent Landscape

US Patent No. 9,855,335 protects a freeze-dried tigecycline injectable formulation using L-arginine or an L-arginine salt as the primary bulking or “propping” agent. The broadest independent claim covers a lyophilized composition containing tigecycline, a qualifying arginine-based propping agent, a pH-adjusting component producing a pre-lyophilization pH of 4.0 to 6.0, and an optional stabilizer. The commercial center of gravity is a 50-mg vial reconstituted with saline, dextrose, or lactated Ringer's solution.

The patent is formulation-specific. It does not broadly cover tigecycline as an active ingredient, all tigecycline injections, the tigecycline molecule, or every lyophilized tigecycline product. Infringement generally requires the accused product to satisfy the formulation, excipient, ratio, pH, and dosage-form limitations of at least one asserted claim.

What does US Patent 9,855,335 protect?

The patent protects four related product categories:

1. A freeze-dried tigecycline composition for injection.
2. The reconstituted pharmaceutical composition produced from that lyophilized powder.
3. A stable reconstituted tigecycline solution.
4. Narrower formulations containing specified arginine ratios and a 50-mg tigecycline dose.

The broadest claim requires all of the following:

Limitation	Required scope
Active ingredient	Tigecycline
Dosage form	Freeze-dried solid composition for injection
Propping agent	L-arginine, L-arginine hydrochloride, or a salt formed by L-arginine with acid or alkali
Propping-agent ratio	0.3 to 4 parts by weight per 1 part tigecycline
pH adjuster	Present in an amount producing pH 4.0 to 6.0 before freeze drying
Stabilizer	Optional; 0 to 2 parts by weight
Physical state	Tigecycline, propping agent, pH adjuster, and optional stabilizer are present as freeze-dried solids

The claim uses a weight-ratio framework rather than an absolute excipient concentration. A 50-mg vial therefore falls within claim 1 if the arginine-based agent is present at 15 mg to 200 mg per 50 mg of tigecycline, subject to the other limitations.

How do the independent claims differ?

Claim 1: Core lyophilized formulation

Claim 1 is the principal composition claim. It requires a freeze-dried tigecycline product with arginine-based bulking material and a pre-lyophilization pH from 4.0 to 6.0.

The claim does not require:

• A 50-mg dose;
• L-arginine rather than an arginine salt;
• Sodium chloride;
• A particular diluent;
• A specific final reconstitution volume; or
• A specific lyophilization cycle.

The claim does require that the listed formulation components be present as freeze-dried solids. A liquid tigecycline formulation would not satisfy the dosage-form limitation.

Claim 6: Reconstituted pharmaceutical composition

Claim 6 covers the product obtained when the freeze-dried composition of claim 1 is reconstituted with a pharmaceutically acceptable diluent. Because claim 6 depends on claim 1, the underlying powder must still contain the claim 1 formulation.

Claim 8: Reconstituted solution

Claim 8 is directed to a stable, pharmaceutically acceptable reconstituted tigecycline solution prepared from the claimed powder. It does not create an independent pathway around claim 1. The solution must originate from a freeze-dried composition meeting claim 1.

Claims 10 to 14: Specific working-ratio embodiments

Claims 10 to 14 identify five narrower ratio embodiments:

Claim	Propping agent	Tigecycline:propping-agent ratio	Pre-lyophilization pH
10	L-arginine	1.0:0.5	4.5
11	L-arginine hydrochloride	1.0:0.61	4.5
12	L-arginine hydrochloride	1.0:1.2	4.5
13	L-arginine hydrochloride	1.0:2.4	4.5
14	L-arginine hydrochloride	1.0:0.3	4.5

These claims are narrower than claim 1 because they fix the pH at 4.5 and specify the propping agent and ratio.

What formulations are protected by US 9,855,335?

The patent covers formulations containing L-arginine or L-arginine hydrochloride within the claimed ratio ranges. It also reaches certain other salts formed by L-arginine with an acid or alkali, subject to claim construction and enablement limits.

L-arginine formulations

L-arginine is expressly covered. Claim 2 narrows claim 1 to L-arginine or L-arginine hydrochloride. Claim 10 identifies a 0.5:1 L-arginine-to-tigecycline ratio, while claim 19 covers L-arginine at a broader 1.2-to-2.4 ratio.

L-arginine hydrochloride formulations

L-arginine hydrochloride is expressly covered in claims 2 and 11 to 14. The listed examples include ratios of 0.3, 0.61, 1.2, and 2.4 parts per part tigecycline.

Other arginine salts

Claims 1 and 21 extend to a salt formed by L-arginine with an acid or alkali. The scope may raise claim-construction questions because the phrase is broader than the specifically named hydrochloride salt. A product using a chemically distinct arginine salt would require analysis of:

• Whether the material is a salt of L-arginine;
• Whether it performs the claimed propping-agent function;
• Whether the salt falls within the written description and enablement of the patent;
• Whether prosecution history narrowed the phrase; and
• Whether the formulation meets the specified ratio and pH.

Sodium chloride as stabilizer

Claim 3 identifies sodium chloride as the stabilizing agent. Sodium chloride is not required by claim 1. A product without sodium chloride can still fall within claim 1 if it satisfies the remaining elements.

The stabilizer ratio is stated as 0 to 2 relative to tigecycline. The “0” value means the broad claim permits no stabilizer. Claims 1 and 3 therefore distinguish between an optional stabilizer in the broad formulation and sodium chloride in the narrower embodiment.

pH adjusters

Claim 4 identifies hydrochloric acid, sodium hydroxide, or a mixture of the two as the pH adjuster. The independent claim does not limit the pH adjuster to these chemicals, but the formulation must produce a pH of 4.0 to 6.0 before freeze drying.

The pH limitation is measured before lyophilization, not necessarily after reconstitution. This creates a potential evidentiary issue in product testing because the relevant pH may not be recoverable directly from the finished vial without manufacturing records or validated analytical reconstruction.

How do the ratio limitations affect infringement?

The ratio limitations are central to the patent's enforceability and design-around analysis.

Broad ratio range

Claim 1 covers a propping-agent-to-tigecycline ratio from 0.3 to 4.0. For a 50-mg tigecycline vial, that corresponds to:

Component	Broad claim 1 range
Tigecycline	50 mg
Propping agent	15 mg to 200 mg
Stabilizer, if used	Up to 100 mg

Claims 15 and 17 create narrower ratio bands:

• Claim 15: propping agent at 0.61 to 2.4 parts per part tigecycline.
• Claim 17: propping agent at 1.2 to 2.4 parts per part tigecycline.

Claims 16 and 18 add the 50-mg dose limitation. Claims 19 and 20 separately specify L-arginine and L-arginine hydrochloride for the 1.2-to-2.4 range.

Boundary issues

A formulation at exactly 0.3, 0.61, 1.2, 2.4, or 4.0 would ordinarily fall within the stated numerical range unless the patent's prosecution history or claim-construction rules establish a different interpretation. A formulation just below or above a boundary may present a literal infringement design-around, but doctrine-of-equivalents exposure would depend on the technical effect of the changed ratio and any prosecution disclaimer.

The ratio must be calculated consistently. Key issues include:

• Whether the ratio uses free-base tigecycline or a tigecycline salt;
• Whether the ratio is based on anhydrous or hydrated ingredient weight;
• Whether L-arginine hydrochloride is measured as supplied;
• Whether the formulation includes overage;
• Whether excipients added during manufacture are included; and
• Whether the specification defines the ratio differently from the claim language.

What dosage forms and diluents are covered?

The patent is directed to parenteral, freeze-dried tigecycline compositions. Claim 5 and claims 16 and 18 identify 50 mg as a protected dose, but the broad composition claim is not limited to 50 mg.

Claim 7 identifies the following diluents:

• Normal saline;
• 5% glucose solution; and
• Lactated Ringer's solution.

These diluents are recited in dependent claims 7 and 9. The broader reconstitution claims use the phrase “pharmaceutically acceptable diluent,” so other diluents may fall within claims 6 and 8 if the underlying lyophilized formulation satisfies claim 1.

The original Tygacil product is supplied as a lyophilized powder for intravenous infusion and is reconstituted before administration. The FDA-approved label identifies a 50-mg vial and specifies reconstitution and dilution instructions for intravenous use.[2]

What is the patent's likely legal scope?

Literal infringement

A competing product has the highest literal-infringement exposure if its product and manufacturing records show:

1. Tigecycline in a freeze-dried injectable vial;
2. L-arginine or L-arginine hydrochloride;
3. A propping-agent ratio between 0.3 and 4.0;
4. A pre-lyophilization pH between 4.0 and 6.0; and
5. The claimed solid-state formulation.

A product can infringe claim 1 even if it does not use sodium chloride, because sodium chloride is optional in that claim.

Product-by-process and manufacturing evidence

The claims are primarily composition claims, but some limitations refer to the state before freeze drying. That creates a mixed infringement analysis. The accused manufacturer may need to produce batch records showing:

• Solution composition before lyophilization;
• pH-adjustment records;
• Ingredient charge quantities;
• The lyophilization process;
• Residual moisture;
• Reconstitution data; and
• Finished-product assay and impurity results.

Finished-product testing alone may not establish the pre-lyophilization pH or the exact ratio if the product has undergone processing changes.

Doctrine of equivalents

The most plausible equivalence disputes would concern:

• A nearby arginine ratio;
• A chemically similar arginine salt;
• A pH slightly outside the claimed range;
• A functionally comparable bulking agent; or
• A formulation in which the claimed components are present in a different physical state.

The doctrine of equivalents is less useful for replacing arginine with an unrelated excipient because the patent expressly identifies the arginine-based propping-agent concept as a central technical feature. Prosecution history may also limit arguments for equivalents around the numerical ranges.

When does US Patent 9,855,335 lose exclusivity?

The patent issued on January 2, 2018.[1] The standard US patent term is generally 20 years from the earliest effective nonprovisional or international filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments.[3]

The issue date alone does not establish the precise expiration date. The controlling term must be taken from the patent's continuity data and USPTO patent-term records. A formulation patent of this type would ordinarily expire substantially later than the original tigecycline compound patent if its effective filing date was later.

Exclusivity element	Relevance
US Patent 9,855,335	Formulation protection for the claimed lyophilized product
Patent term adjustment	May extend the ordinary 20-year term
Patent-term extension	Potentially relevant only if statutory requirements are met
Regulatory exclusivity	Separate from patent protection
Orange Book listing	Determines whether an ANDA applicant must address the patent
Compound patent	Separate protection for tigecycline itself
Method-of-use patents	May create additional barriers unrelated to formulation

The patent should not be treated as an automatic bar to every generic tigecycline launch. Its practical value depends on whether it is listed for the reference product, whether the proposed generic uses the claimed excipients and ratios, and whether the applicant files a Paragraph IV certification.

What is the Orange Book status of US 9,855,335?

The Orange Book is the FDA's authoritative source for patents submitted by an NDA holder and accepted for listing against an approved drug product.[4] A patent number does not establish Orange Book listing by itself.

The relevant regulatory distinction is:

• If US 9,855,335 is listed against Tygacil or an approved tigecycline NDA, an ANDA applicant may need to certify to it.
• If it is not listed, the patent may still be enforceable against a commercial product, but it ordinarily would not create the same ANDA certification and 30-month-stay pathway.
• A formulation patent may be listed only if it claims the drug substance, drug product, or an approved method of use in a manner accepted under FDA listing rules.

Tygacil is an NDA product for intravenous tigecycline. Its approved labeling identifies tigecycline for injection as a lyophilized product in 50-mg vials.[2] The Orange Book must be checked by NDA number and product record, not solely by the patent number, because patent listing, delisting, expiration, and pediatric exclusivity can change over time.

How does US 9,855,335 compare with the original tigecycline patent estate?

The patent estates address different technical layers.

Estate	Protected subject matter	Commercial effect
Original tigecycline compound patents	Tigecycline chemical entity and related compounds	Broadest molecule-level protection
Tygacil product patents	Approved injectable product and formulation features	Product-specific protection
US 9,855,335	Freeze-dried tigecycline with arginine-based propping agent, pH 4.0-6.0, and specified ratios	Narrower formulation protection
Method-of-use patents	Treatment of specified infections or patient populations	Use-specific exposure
Process patents	Manufacture, purification, drying, or impurity control	Manufacturing-specific barriers

A generic company can potentially avoid US 9,855,335 by using:

• A non-arginine bulking agent;
• A propping-agent ratio outside 0.3 to 4.0;
• A pre-lyophilization pH outside 4.0 to 6.0;
• A non-lyophilized dosage form, if approved and clinically appropriate; or
• A different composition that does not contain the claimed combination.

Those alternatives may be commercially difficult because tigecycline is degradation-sensitive and the arginine-based formulation may be used to improve cake structure, reconstitution, stability, or impurity control. A technically viable design-around must satisfy FDA quality requirements, not merely avoid a patent claim.

Which companies are challenging the tigecycline formulation estate?

ANDA competition for tigecycline has historically involved generic injectable manufacturers. Potential challengers include companies with approved or developing tigecycline injection products, contract manufacturers, and vertically integrated generic suppliers.

The decisive legal question is whether a specific applicant has:

• Filed an ANDA referencing Tygacil;
• Filed a Paragraph IV certification to US 9,855,335;
• Received an infringement suit within 45 days;
• Obtained a court judgment or settlement;
• Received a final approval date; and
• Launched a product that practices the claimed formulation.

A company can challenge the patent without publicly disclosing all formulation details. ANDA litigation records, FDA approval letters, district-court complaints, and settlement filings are therefore more probative than product marketing materials.

What Paragraph IV risks exist for a tigecycline generic?

A Paragraph IV challenge could attack the patent on several grounds.

Noninfringement

The applicant may certify that its formulation does not contain:

• An arginine-based propping agent;
• The claimed ratio;
• A pre-lyophilization pH of 4.0 to 6.0; or
• The claimed freeze-dried solid combination.

This is the most direct route where the generic formulation uses a different excipient system.

Anticipation

An anticipation defense would require a single prior-art reference disclosing every limitation of an asserted claim, including the combination of:

• Tigecycline;
• The specified arginine-based agent;
• The required ratio;
• The pre-lyophilization pH; and
• The freeze-dried injectable form.

Prior art showing tigecycline lyophilization alone would not anticipate claim 1 if it lacks the arginine limitation or the claimed pH and ratio.

Obviousness

Obviousness is the principal validity risk. A challenger could combine references concerning:

• Tigecycline injectable formulations;
• L-arginine as a lyophilization bulking or stabilizing agent;
• pH optimization for tetracycline-class antibiotics;
• Reconstitution stability; and
• Conventional 50-mg vial presentation.

The patent holder would likely rely on unexpected stability, reduced degradation, improved cake structure, or improved reconstitution performance. Comparative data are important. The stronger the improvement over alternative excipients and ratios, the stronger the asserted nonobviousness position.

Written description and enablement

Claims 1 and 21 cover a broad class of L-arginine salts, while the listed examples focus on L-arginine and L-arginine hydrochloride. A challenger may argue that the specification does not adequately support or enable every acid or alkali salt within the broader language.

The broad 0.3-to-4.0 ratio and pH 4.0-to-6.0 range may also be tested against the number of working examples and the amount of experimentation needed to achieve stable products throughout the full range.

Indefiniteness

“Propping agent” is an unusual term compared with standard pharmaceutical terms such as bulking agent or cake-forming agent. Its meaning would likely be derived from the specification and technical context. The ratio language may create additional disputes if the patent does not specify the measurement basis for tigecycline and arginine salts.

What litigation affects US 9,855,335?

The patent's litigation significance depends on whether it has been asserted against an ANDA applicant or commercial manufacturer. Relevant proceedings would include:

• Hatch-Waxman suits filed within 45 days of a Paragraph IV notice;
• Declaratory-judgment actions;
• Patent Office inter partes review petitions;
• District-court validity or infringement decisions;
• Consent judgments;
• Launch-at-risk activity; and
• Settlement agreements involving delayed generic entry.

A litigation search should use the exact patent number, the patent title, the patent owner, the NDA holder, and the active ingredient “tigecycline.” A search limited to the brand name may miss proceedings filed by generic applicants or assignees using corporate names.

No litigation conclusion should be drawn solely from the patent's existence. An unasserted patent can have substantial residual FTO relevance, while an asserted patent may have limited commercial value after a noninfringement ruling, claim cancellation, settlement, or expiry.

Are there settlement agreements involving this patent?

Settlement agreements are commercially important because they can establish a licensed entry date without producing a publicly litigated merits decision. Relevant terms may include:

• Authorized-generic rights;
• Delayed entry;
• Supply agreements;
• Royalty arrangements;
• No-challenge provisions;
• Geographic restrictions; and
• Restrictions on formulation or manufacturing sites.

Settlement analysis must distinguish agreements involving US 9,855,335 from agreements involving separate tigecycline patents. A settlement concerning the compound patent does not necessarily resolve the formulation claims in this patent.

How strong is the patent estate for US 9,855,335?

The patent has meaningful but concentrated value.

Strength factor	Assessment
Technical specificity	Strongly defined around lyophilized tigecycline and arginine
Breadth	Moderate; claim 1 covers a broad ratio and optional stabilizer
Design-around potential	Moderate to high if alternative excipients produce an acceptable product
Detectability	Moderate; final product testing may not reveal pre-lyophilization pH
Validity exposure	Moderate; conventional excipient and lyophilization technology may support obviousness arguments
Commercial relevance	High if the accused product uses L-arginine or L-arginine hydrochloride
Orange Book leverage	Dependent on FDA listing status
Manufacturing barrier	Potentially meaningful because formulation changes require CMC development and regulatory support

The strongest claims for enforcement are likely claims 10 to 14 if the accused product matches one of the specified 4.5 pH and ratio embodiments. Those claims are narrower but easier to map to a product with matching batch records. Claim 1 has broader coverage but faces more substantial validity and claim-construction challenges.

What generic launch scenarios exist?

Scenario 1: Non-arginine design-around

A generic uses another bulking agent and avoids the express arginine limitation. This may reduce literal infringement exposure but could require new stability and lyophilization development.

Scenario 2: Ratio design-around

A generic uses L-arginine or L-arginine hydrochloride outside the 0.3-to-4.0 range. This approach is vulnerable if the change is small and the patent holder asserts equivalents.

Scenario 3: pH design-around

A generic targets a pre-lyophilization pH below 4.0 or above 6.0. The regulatory risk may be greater because pH affects tigecycline degradation, reconstitution, infusion tolerability, and product quality.

Scenario 4: Paragraph IV litigation

The applicant certifies that the patent is invalid, unenforceable, or not infringed. A timely suit can trigger the statutory 30-month stay, subject to court action and regulatory exclusivity rules.[5]

Scenario 5: Post-expiry launch

The applicant waits until patent expiry or an agreed settlement date. This reduces litigation exposure but may sacrifice early market entry and first-filer advantages.

What geographic coverage does the patent provide?

US 9,855,335 provides protection in the United States only. Corresponding foreign rights would depend on the patent family, national-stage filings, continuations, and local prosecution outcomes.

A global FTO review should separate:

• United States;
• European Patent Convention states;
• China;
• Japan;
• Canada;
• Australia;
• Brazil; and
• Other markets where tigecycline injection is sold or manufactured.

A granted US patent does not establish enforceable rights in those jurisdictions. Foreign family members may have different claims, expiry dates, ownership, prosecution amendments, and legal status.

What manufacturing and IP barriers remain after patent expiry?

Patent expiry does not eliminate all market barriers. A generic tigecycline injection must still address:

• Sterile manufacturing validation;
• Lyophilization cycle control;
• Reconstitution time;
• Impurity and degradation specifications;
• Container-closure integrity;
• Extractables and leachables;
• Stability through the labeled shelf life;
• Bioequivalence or applicable injectable-product requirements; and
• FDA approval under the ANDA pathway.

Tigecycline's formulation-sensitive nature can make CMC development a stronger practical barrier than the patent alone. A design-around that avoids arginine but produces inferior stability may be legally viable and commercially unusable.

Key Takeaways

• US 9,855,335 is a formulation patent, not a compound patent.
• Claim 1 covers freeze-dried tigecycline with L-arginine, L-arginine hydrochloride, or another qualifying L-arginine salt.
• The critical numerical limits are a propping-agent ratio of 0.3 to 4.0 and a pre-lyophilization pH of 4.0 to 6.0.
• Sodium chloride is optional in the broad claim and expressly recited only in a dependent claim.
• The patent reaches 50-mg products through dependent claims but is not broadly limited to a 50-mg vial.
• Claims 10 to 14 target specific 4.5-pH formulations and ratios of 0.3, 0.5, 0.61, 1.2, and 2.4.
• The principal generic defenses are noninfringement, obviousness, anticipation, written-description deficiency, enablement, and indefiniteness.
• Orange Book significance depends on whether the patent was submitted and accepted for listing against the relevant tigecycline NDA.
• The practical design-around path is usually a different excipient system, a materially different ratio, or a different pH, but each option creates CMC and regulatory risk.
• The precise expiration date requires the patent's effective filing date, patent-term adjustment, and any terminal-disclaimer or extension data.

FAQs

Is US 9,855,335 a patent on Tygacil itself?

No. It covers specified freeze-dried tigecycline formulations. It does not broadly claim the tigecycline molecule.

Does a tigecycline vial without L-arginine infringe this patent?

It is less likely to infringe the literal language of the principal claims because an arginine-based propping agent is required. Other patents and regulatory requirements may still apply.

Does using L-arginine hydrochloride automatically create infringement?

No. The product must also satisfy the freeze-dried dosage-form, tigecycline, ratio, pH, and other applicable limitations.

Can a generic avoid the patent by changing the reconstitution diluent?

Usually not if the underlying powder satisfies claim 1. Claims 6 to 9 address reconstituted products, but changing the diluent does not necessarily avoid the composition claims.

Does expiration of the original tigecycline compound patent eliminate this formulation patent?

No. Compound-patent expiry and formulation-patent expiry are separate events. A generic may face formulation claims after molecule-level protection has ended.

References

1. United States Patent and Trademark Office. (2018). U.S. Patent No. 9,855,335, freeze-dried tigecycline composition for injection.
2. U.S. Food and Drug Administration. (2023). Tygacil (tigecycline) for injection prescribing information. Pfizer Labs.
3. United States Code, 35 U.S.C. §§ 154, 156, 271, 282.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
5. U.S. Food and Drug Administration. (2024). Abbreviated new drug application regulations and patent certification requirements, 21 C.F.R. § 314.101 and § 314.107.

Drugs Protected by US Patent 9,855,335

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	211158-001	Aug 2, 2018	AP	RX	No	No			Y

Foreign Priority and PCT Information for Patent: 9,855,335

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
China	2012 1 0078509	Mar 22, 2012

PCT Information
PCT Filed	April 07, 2013	PCT Application Number:	PCT/CN2013/000397
PCT Publication Date:	September 26, 2013	PCT Publication Number:	WO2013/139179

International Family Members for US Patent 9,855,335

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2879383
China	103315947
European Patent Office	2881109
Spain	2795421
Poland	2881109
Portugal	2881109
Russian Federation	2015100116