8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (Date of earliest event reported) October 15, 2008

INSPIRE PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware	000-31135	04-3209022
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

4222 Emperor Boulevard, Suite 200, Durham, North Carolina	27703-8466
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code (919) 941-9777

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On October 15, 2008, Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) issued a press release, attached to and made part of this report, announcing the issuance of a method of treatment patent related to Elestat^® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis (“Elestat”). This patent, U.S. Patent No. 7,429,602, entitled “Treating Conjunctivitis by Topically Administering an Epinastine Solution to the Conjunctiva,” was issued to an affiliate of Boehringer Ingelheim (“Boehringer Ingelheim”), the developer of the invention, and expires on November 29, 2020. Under the terms of an existing agreement with Allergan, Inspire has the responsibility for promoting and marketing Elestat to ophthalmologists, optometrists and allergists in the United States.

The five year commercial exclusivity period awarded to Elestat as a new chemical entity, as provided under the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act, expires October 15, 2008. After such time, competitors will be able to submit to the U.S. Food and Drug Administration (“FDA”), for review in its standard review cycle, an Abbreviated New Drug Application (“ANDA”) or a 505(b)(2) referencing the New Drug Application of epinastine HCl ophthalmic solution. Upon submission of an ANDA, the generic applicant must certify to the FDA that either (i) no patents are listed for the applicable product in the FDA publication Approved Drug Products with Therapeutic Equivalence (commonly called the “Orange Book”), or that (ii) any Orange Book listed patents have expired, or that (iii) approval is sought only after their expiration, or that (iv) any Orange Book listed patent is invalid or will not be infringed by the manufacture, use, or sale of the generic product. A certification that a listed patent is invalid or will not be infringed is commonly referred to as a Paragraph IV certification.

If an ANDA applicant makes a Paragraph IV certification pertaining to Elestat, such applicant is required to give notice to Boehringer Ingelheim (or its representative), as the owner of the listed patent, and to Allergan (or its representative), as the holder of the Elestat NDA. The owner of a listed patent that is the subject of the certification and, in certain circumstances, another party holding all substantial rights to the listed patent, will have the right in accordance with applicable law to initiate suit against an ANDA applicant for patent infringement, notwithstanding the fact that manufacturing and sales of the generic product will not yet have commenced. Inspire does not have a license to the Elestat patent. If a lawsuit is initiated within 45 days from the date of receipt of the ANDA applicant’s Paragraph IV certification, a stay is triggered under applicable law, which provides that the ANDA application will not be approved for 30 months, or until a final court decision in the infringement suit in favor of the ANDA applicant, whichever occurs first. Such stay is subject to reduction or extension in length by the court, if a party does not cooperate in reasonably expediting the patent litigation.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

No.	Description
99.1	Press Release dated October 15, 2008

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Inspire Pharmaceuticals, Inc.
By:	/s/ Christy L. Shaffer
	Christy L. Shaffer,
	President and Chief Executive Officer

Dated: October 15, 2008

EXHIBIT INDEX

No.	Description
99.1	Press Release dated October 15, 2008

EX-99.1

Exhibit 99.1

For Immediate Release

Investor Contact:	Media Contact:
Inspire Pharmaceuticals, Inc.	BMC Communications
Jenny Kobin	Dan Budwick
VP, Investor Relations and Corporate Communications	(973) 271-6085
(919) 941-9777, Extension 219

INSPIRE ANNOUNCES ISSUANCE OF PATENT FOR ELESTAT^®

DURHAM, NC - October 15, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that the U.S. Patent and Trademark Office has issued a method of treatment patent related to Elestat^® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis. This patent, U.S. Patent No. 7,429,602, entitled “Treating Conjunctivitis by Administering an Epinastine Solution to the Conjunctiva,” was issued to Boehringer Ingelheim International GmbH, the developer of the invention, and expires on November 29, 2020.

Elestat, a topical antihistamine with mast cell stabilizing and anti-inflammatory activity, is licensed from Boehringer Ingelheim and was developed by Allergan, Inc. for the relief of ocular itching associated with ocular allergies. Following the approval of the drug in 2003, Allergan entered into a co-promotion agreement with Inspire pursuant to which Inspire obtained the primary responsibility for selling, promotional and marketing activities in the United States related to Elestat.

Christy L. Shaffer, Ph.D., President and Chief Executive Officer of Inspire, said, “As Elestat is an important product for Inspire, we are pleased to have patent coverage for Elestat that extends beyond the exclusivity period granted under the Hatch-Waxman Act. We look forward to continuing our promotion of Elestat.”

About Elestat^®

Elestat^® (epinastine HCl ophthalmic solution) 0.05% provides fast-acting, long-lasting relief of ocular itching and is soothing to the eyes. Elestat is a mast cell stabilizer, a potent antihistamine and the only product with labeling that cites activity at both the H₁ and H₂ receptors. Elestat ophthalmic solution is indicated for the prevention of ocular itching associated with allergic conjunctivitis. The most frequently reported ocular adverse events occurring in approximately 1% to 10% of patients were burning sensation in the eye, folliculosis, hyperemia and pruritis. The most frequently reported nonocular adverse events were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough and pharyngitis seen in approximately 1% to 3% of patients. Some of these events were similar to the underlying disease being studied. Patients should be advised not to wear a contact lens if their eye is red.

4222 Emperor Boulevard, Suite 200 • Durham, North Carolina 27703

Telephone 919.941.9777 • Fax 919.941.9797

About Inspire

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire is currently developing products for dry eye, cystic fibrosis and glaucoma. Inspire employs a U.S. sales force for the promotion of AzaSite^® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat^® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis^® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Elestat and Restasis are registered trademarks owned by Allergan, Inc. AzaSite is a registered trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.

Forward-Looking Statements

The forward-looking statements in this news release relating to management’s expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurance can be made with respect to the scope or duration of the patent coverage relating to Elestat or the length of time that Inspire will continue to promote Elestat. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, adverse litigation developments, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire’s results is included in Inspire’s filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.

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4222 Emperor Boulevard, Suite 200 — Durham, North Carolina 27703

Telephone 919.941.9777 — Fax 919.941.9797