Details for Patent: 7,531,623
Which drugs does patent 7,531,623 protect, and when does it expire?
Patent 7,531,623 protects VIBATIV and is included in one NDA.
This patent has thirty-three patent family members in eighteen countries.
Summary for Patent: 7,531,623
| Title: | Hydrochloride salts of a glycopeptide phosphonate derivative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Disclosed are hydrochloride salts of telavancin having a chloride ion content of from about 2.4 wt. % to about 4.8 wt. %. The disclosed salts have improved stability during storage at ambient temperatures compared to other hydrochloride salts. Also disclosed are processes for preparing such salts. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Jyanwei Liu, Junning Lee | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Cumberland Pharmaceuticals Inc | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US10/970,128 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Composition; Process; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | U.S. Patent 7,531,623: Telavancin Hydrochloride Claim Scope, Expiration, and Patent LandscapeU.S. Patent 7,531,623 protects a defined hydrochloride salt of telavancin, principally through chloride-ion content and approximately two molar equivalents of hydrochloride per mole of telavancin. It also protects a pH-controlled manufacturing process used to produce that salt. The patent issued to Theravance, Inc. and covered the active pharmaceutical ingredient used in Vibativ. The Orange Book-listed patent term ended on February 15, 2025.[1] The patent is important because it is a salt and manufacturing patent rather than a broad composition-of-matter patent covering the telavancin molecule itself. Its strongest claims target the specific hydrochloride form used commercially and the process conditions that generate it. What does U.S. Patent 7,531,623 cover?The patent covers two related subject matter groups:
The independent claims are claims 1, 4, 10, and 13.
Claims 2, 3, 11, and 12 narrow the chloride range. Claims 5-9 narrow the process by specifying pH subranges, solvent, base, and isolation technique. The supplied text contains a typographical error in claim 12, which states "telavancin having a chloride ion content from about 3.7 wt. Va." The corresponding limitation is understood as 3.7 wt.% to about 3.9 wt.%, consistent with claim 3 and the issued claim structure. How do the product claims define telavancin hydrochloride?Claims 1-3 and 10-12 define the salt by chloride-ion content rather than by a full crystal-structure, polymorph, particle-size, or hydration specification. The principal range is:
The dependent ranges are:
The claims therefore divide the covered material into overlapping bands. Claims 2 and 3 together substantially partition the range in claim 1, with the boundary at about 3.9 wt.%. Why is chloride content commercially significant?Telavancin is a large glycopeptide antibiotic. Its hydrochloride salt can incorporate more than one equivalent of hydrochloride. A dihydrochloride form would theoretically contain approximately 70.9 grams of chloride per mole of salt, assuming two chloride ions per telavancin molecule. Relative to the molecular weight of telavancin dihydrochloride, this corresponds approximately to the claimed 3.7-4.4 wt.% range. Claim 13 captures the same commercial salt using a molar-equivalent definition:
Claims 1 and 13 are related but are not identical in wording. A product may fall within the chloride-weight range without precisely matching an accused party's characterization of the salt stoichiometry, or vice versa. In litigation, analytical testing would likely be central. What is the scope of the telavancin hydrochloride composition claims?The product claims are composition claims. They do not require proof of how the material was manufactured. A product potentially falls within claims 1 or 10 if testing establishes that it is:
The principal infringement issue is whether "about" permits a tolerance outside the express numerical range. That question would depend on claim construction, the patent specification, analytical precision, and the technical meaning of the range in the field. A product containing 3.8 wt.% chloride would be a straightforward literal-range case. A product at 3.6 or 4.5 wt.% would present a more difficult issue. The claims do not expressly require:
That makes the composition claims potentially applicable to bulk active ingredient and to finished drug product containing the claimed salt, subject to the claim language and proof that the salt itself is present in the claimed form. What process is protected by claim 4?Claim 4 requires every element of a specific manufacturing sequence:
The dependent claims narrow the process as follows:
The process claims are narrower than the product claims because they require a particular starting condition and processing sequence. A generic manufacturer could avoid literal infringement of claim 4 by using a different salt-conversion route, a different pH history, a nonaqueous system, or a process that does not begin with a material above 4.8 wt.% chloride. That strategy would not necessarily avoid the product claims if the resulting isolated salt still falls within the claimed composition range. How does claim 13 compare with claims 1 and 10?Claim 13 uses salt stoichiometry rather than chloride weight percentage. It covers:
Claims 1 and 10 use an analytical chloride-content range. Claim 13 is therefore potentially broader in one respect because it does not state the 3.7-4.4 wt.% range. It may also create proof issues because the number of hydrochloride equivalents can depend on the analytical method, the molecular-weight basis used, hydration, counterion accounting, and whether the material is a uniform salt or a mixture. A commercial telavancin dihydrochloride product would be the primary target of both types of claim. A manufacturer would normally evaluate the claims together rather than treating claim 13 as an alternative of limited importance. When did U.S. Patent 7,531,623 expire?The patent was filed on February 15, 2005 and issued on May 12, 2009. The listed expiration date was February 15, 2025.[1]
The patent's expiration removes the principal U.S. patent barrier created by this patent. It does not eliminate other possible barriers, including separate patents, regulatory exclusivity, trade secrets, manufacturing know-how, or contractual restrictions. What was the Orange Book status of U.S. Patent 7,531,623?U.S. Patent 7,531,623 was listed in the FDA Orange Book for Vibativ, telavancin hydrochloride for injection, marketed by Cumberland Pharmaceuticals after the U.S. rights transition from Theravance Biopharma.[1,2] The patent was associated with the approved telavancin product rather than with a biosimilar pathway. Telavancin is a chemically synthesized small-molecule glycopeptide antibiotic, so an abbreviated new drug application, or ANDA, is the relevant generic pathway. A 351(k) biosimilar application is not the applicable route. An Orange Book listing does not itself establish that every patent claim would be infringed by every generic product. It identifies patents submitted by the NDA holder or patent owner as relevant to the approved drug. What Paragraph IV risks applied to telavancin hydrochloride?An ANDA applicant seeking approval before patent expiration could have challenged the patent through a Paragraph IV certification. The applicant would need to assert that the patent was invalid, unenforceable, or would not be infringed by the proposed product. The most plausible Paragraph IV theories would have included:
The commercial value of a Paragraph IV challenge declined materially after February 15, 2025, because the patent term had ended. A post-expiration ANDA applicant would generally have no need to incur the same infringement litigation risk for this patent, although earlier filing and approval strategies could have justified a challenge before expiration. Publicly identified litigation and settlement activity tied specifically to U.S. Patent 7,531,623 should be checked against the FDA Orange Book, PACER, and USPTO records for a transaction-level conclusion. The patent's expiration means that any historical Paragraph IV dispute no longer creates a current injunction risk under this patent. What other patents protected Vibativ and telavancin?The patent landscape included several categories of rights:
The core compound patent estate for telavancin was older than U.S. 7,531,623 because the active ingredient had been disclosed and developed before the salt patent's 2005 filing. The salt patent therefore functioned as a later-life-cycle protection layer. A complete freedom-to-operate analysis cannot rely on U.S. 7,531,623 alone. It must review:
What formulations are protected by U.S. Patent 7,531,623?The patent does not claim a finished injectable formulation in the conventional sense. It claims telavancin hydrochloride as a salt and claims a process for making it. The patent does not expressly require:
A finished Vibativ vial could implicate the patent if it contains telavancin hydrochloride within the claimed chloride range. The patent does not, however, establish exclusive ownership of every injectable formulation containing telavancin. How strong was the patent estate for telavancin hydrochloride?Before expiration, U.S. 7,531,623 had meaningful blocking value because the claims covered the commercial salt itself, not merely a manufacturing step. A competitor could potentially design around the process claims but would face a more difficult design-around problem if the commercially acceptable product necessarily used the claimed dihydrochloride form. Its weaknesses were structural:
As of the patent's listed expiration date, its current blocking strength is zero as an enforceable U.S. patent right. Its historical value remains relevant to the timing of generic entry and any prior litigation. What licensing deals affected telavancin commercialization?Telavancin was developed by Theravance and commercialized through successive strategic arrangements. Astellas obtained rights during an earlier commercialization phase, but those rights were later returned. Theravance subsequently transferred or partnered U.S. commercialization rights with Cumberland Pharmaceuticals, which marketed Vibativ in the United States.[3,4] These transactions affected commercial control, supply, and regulatory responsibilities. They did not extend the statutory term of U.S. Patent 7,531,623. Private licensing agreements can allocate patent rights and enforcement authority, but they cannot extend an expired patent against the public. What generic entry scenarios existed after patent expiration?The principal post-expiration scenarios are: Direct generic entryAn ANDA applicant can seek approval for telavancin hydrochloride for the same reference-listed drug indications, subject to FDA requirements for pharmaceutical equivalence, bioequivalence, chemistry, manufacturing, and controls. Alternative salt or solid-form entryA manufacturer could develop a different salt, polymorph, or solid form. That approach may avoid claims limited to the patented hydrochloride composition but could create new comparability, stability, and regulatory issues. Contract manufacturing entryA generic sponsor could use a contract manufacturer with independent process know-how. The manufacturing route would need to be evaluated against any surviving process patents, not only U.S. 7,531,623. Limited commercial entryTelavancin's hospital-focused market, complex glycopeptide manufacture, safety profile, and limited infectious-disease use may reduce the number of commercially interested ANDA applicants even after patent expiry. Patent expiration removes a legal barrier but does not guarantee immediate competition. How does telavancin compare with other lipoglycopeptide antibiotics?
Telavancin does not present biosimilar risk in the regulatory sense. Its competitive risk comes from generic small-molecule development, hospital formulary substitution, alternative long-acting antibiotics, and manufacturing economics. Key Takeaways
FAQs About U.S. Patent 7,531,623Does U.S. Patent 7,531,623 cover telavancin itself?No. Its principal claims cover a specific hydrochloride salt form of telavancin and a process for preparing that form. The patent is not a broad patent on every form of the telavancin molecule. Can a generic manufacturer avoid the patent by using a different manufacturing process?Before expiration, a different process could have avoided the process claims if all required steps were absent. It would not necessarily have avoided the composition claims if the final product still had the claimed telavancin hydrochloride composition. Is telavancin eligible for a biosimilar application?No. Telavancin is a chemically synthesized small molecule. The relevant abbreviated pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. What analytical test would be central to a claim dispute?Chloride assay and salt-stoichiometry testing would be central. The parties would also likely examine water content, molecular-weight basis, sample preparation, method validation, and whether the measured value falls within the claimed range. Did patent expiration automatically authorize every telavancin generic product?No. Expiration removed the enforceable term of U.S. 7,531,623. A generic product would still require FDA approval and would need to address any other unexpired patents, regulatory requirements, manufacturing controls, and contractual restrictions. References
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Drugs Protected by US Patent 7,531,623
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-001 | Sep 11, 2009 | DISCN | Yes | No | 7,531,623 | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| Apotex | VIBATIV | telavancin hydrochloride | POWDER;INTRAVENOUS | 022110-002 | Sep 11, 2009 | RX | Yes | Yes | 7,531,623 | ⤷ 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 |
International Family Members for US Patent 7,531,623
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2004285924 | ⤷ Start Trial | |||
| Brazil | PI0415853 | ⤷ Start Trial | |||
| Canada | 2543009 | ⤷ Start Trial | |||
| Canada | 2726967 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
