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Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Metronidazole Vaginal Gel, 0
Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Metronidazole Vaginal Gel, 0.75% (”Product”). Saptalis’s Product is therapeutically equivalent to the Reference Listed Drug (RLD), Metrogel - Vaginal®, 0.75%, Bausch Health.
Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis.
Saptalis’ Product is available in 70 gm tubes packaged with 5 vaginal applicators. The current annual U.S. market for Metronidazole Vaginal Gel, 0.75% is approximately $34 million, according to the latest estimates from IQVIA/IMS Health, with 1.7 million units sold annually.
Saptalis’s Metronidazole vaginal gel product is manufactured at its facility in Hauppauge, NY and will be launched in the next few weeks.
Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Glycopyrrolate Oral Solution 1mg/5mL (”Product”)
Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Glycopyrrolate Oral Solution 1mg/5mL (”Product”). Saptalis’s Product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Cuvposa®, Glycopyrrolate Oral Solution, 1mg/5 mL, Merz Pharmaceuticals, LLC.
Glycopyrrolate is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).
Saptalis’ Product is available in 473mL Bottles. The current annual U.S. market for Glycopyrrolate Solution is approximately $12 million, according to the latest estimates from IQVIA/IMS Health.
Saptalis plans to launch the Product in the next few weeks.
Saptalis Pharmaceuticals, LLC, announced today that it has received the U
Saptalis Pharmaceuticals, LLC, announced today that it has received the U.S. FDA approval of its Abbreviated New Drug Application for Cyclosporine Ophthalmic Emulsion, 0.05%. Saptalis’ product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Restasis®, Abbvie, Inc. The Saptalis product is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial. Five (5) vials are packaged in an aluminum pouch; 6 or 12 such pouches are placed in a carton. The product can be dispensed as 30 vials and 60 vials.
Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular infection associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking anti-inflammatory drugs or using punctal plugs.
According to the latest estimates from IQVIA/IMS Health, the current annual U.S. market for Cyclosporine Ophthalmic Emulsion 0.05% in single dose vials is >$ 2 billion. The product is widely used, with over 250 million single dose vials dispensed annually in the US.
“Saptalis is very pleased with the FDA approval of the complex sterile ophthalmic product. The success is the result of several years of collaboration between Saptalis and our development and manufacturing partner, Taejoon Pharmaceutical Co., Ltd.“, said Dr. Polireddy Dondeti, President & CEO of Saptalis.
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of innovative and generic products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that is US FDA – GMP approved. Saptalis manufactures and supplies to the US market a wide range of FDA approved prescription products.
Taejoon Pharmaceutical Co., Ltd. (“Taejoon”) is a leading specialty pharmaceutical company in Korea. The company specializes in ophthalmology, image contrast agents (MRI and CT), and gastrointestinal products. Taejoon is an FDA and EU-GMP approved manufacturer exporting ophthalmic products to U.S., EU and Asia.
Saptalis expects to launch Cyclosporine Ophthalmic Emulsion under Saptalis label in the next several weeks.
Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Lithium Oral Solution USP, 8 mEq/5 mL
Saptalis Pharmaceuticals, LLC announced today that the FDA approved its ANDA for Lithium Oral Solution USP, 8 mEq/5 mL. Saptalis product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lithium Oral Solution, 8 mEq/5 mL, of Hikma Pharmaceuticals USA Inc. (Hikma). The product was discontinued by Hikma several years ago and was on the FDA Drug Shortage list until recently.
Saptalis' Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar disorder. It is approved for the treatment of acute manic and mixed episodes in patients 7 years and older, as well as maintenance treatment in patients 7 years and older.
"An estimated 2.8% of U.S. adults had bipolar disorder last year", said Dr. Polireddy Dondeti, President & CEO of Saptalis. "An estimated 4.4% of U.S. adults experience bipolar disorder at some time in their lives. Saptalis is very pleased to reintroduce to the U.S. market this highly needed liquid form of Lithium medication".
Saptalis' Lithium Oral Solution is available in two sizes: Bottles (473mL) and Unit Dose cups (5 mL). The product has currently only one generic competitor (for 473mL only) and Saptalis expects the annual market for the product to be about $6 million USD.
The product will be marketed and distributed under the Saptalis label by the Saptalis marketing team.
Saptalis Pharmaceuticals, LLC announced today that the Company has launched its Hydrocortisone and Acetic Acid Otic Solution, USP 2%;1%
Saptalis Pharmaceuticals, LLC announced today that the Company has launched its Hydrocortisone and Acetic Acid Otic Solution, USP 2%;1%. The product is indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to antimicrobial action, which are complicated by inflammation. Saptalis has acquired NDA for Hydrocortisone and Acetic Acid (Vosol®) from Akorn Operating Company Co., LLC, transferred the manufacturing to its facility in Hauppauge, NY and filed CBE 30 Supplement.
According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Hydrocortisone and Acetic Acid Otic Solution is approximately $10 million.
The product has limited generic competition.
The product will be marketed by the Company sales team under Saptalis own label.
Saptalis Pharmaceuticals, LLC is pleased to announce the FDA approval of its New Drug Application of Metronidazole Oral Suspension 500mg/5mL, submitted pursuant to section (505) (b) (2) and commercial launch of the product under the brand name LIKMEZTM
Saptalis Pharmaceuticals, LLC is pleased to announce the FDA approval of its New Drug Application of Metronidazole Oral Suspension 500mg/5mL, submitted pursuant to section (505) (b) (2) and commercial launch of the product under the brand name LIKMEZTM.
LIKMEZTM is the first and only FDA approved ready-to-use oral suspension of metronidazole widely used for the treatment of various infections caused by bacteria or parasites. LIKMEZTM is approved for the treatment of trichomoniasis and anaerobic bacterial infections in adults and amebiasis in adults and pediatric patients. LIKMEZTM comes in a 200 mL bottle as a strawberry peppermint flavored suspension, with a 24-month shelf life and does not require refrigeration. Metronidazole has been shown to be carcinogenic in mice and rats, and the most common adverse reactions of metronidazole include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation.
LIKMEZTM is a novel proprietary liquid formulation of metronidazole for patients with difficulty swallowing, and high taste sensitivities, which can present obstacles for compliance and persistency which may lead to treatment discontinuation. LIKMEZTM addresses inherent risks associated with crushing tablets for the patients with swallowing obstacles and eliminates the potential inconsistences associated with extemporaneously compounding metronidazole prescriptions. Additionally, compounding can amplify the pronounced bitter, metallic taste of metronidazole tablets, which can also negatively influence patients' adherence to therapy. LIKMEZTM oral suspension provides a convenient alternative for pediatric and a growing number of elderly patients.
The taste masking proprietary formulation of metronidazole was developed by Appili Therapeutics Inc., HALIFAX, Nova Scotia (TSX: APLI; OTCQB: APLIF), an infectious disease biopharmaceutical company, and protected by the US patent with expiration date in 2039. Appili assigned the rights to the product and the underlying technology to Saptalis for commercialization in the US, and other selected territories. Per the exclusive licensing agreement, Saptalis is responsible for all manufacturing, regulatory and marketing activities.
"We are pleased with the approval of the NDA for LIKMEZTM, which is our first branded product", said Polireddy Dondeti, Ph.D., President and Chief Executive Officer of Saptalis. "We are proud of our team which, using Appili's taste masking technology, has successfully developed and manufactured the product and secured its approval by the FDA. LIKMEZTM will address a clear market need in a more convenient dosage form of metronidazole".
To commercialize LIKMEZTM in the US, Saptalis has entered into an exclusive marketing agreement with Kesin Pharma Corporation (Oldsmar, FL), a pharmaceutical company focused on marketing and distribution of innovative specialty branded products. Using its Specialty Field Sales Team and Engagement Center, Kesin will build awareness and education of health care providers across broad market space including Retail, Hospital/Acute, LTC Pharmacy.
LIKMEZTM will be available through most full-line wholesalers and retail pharmacies. To learn more and view Full Prescribing Information, including BOXED WARNING and additional Safety Information see www.LIKMEZ.com.
The launch of Triamcinolone Acetonide Topical Cream will be followed by the introduction of additional products currently under review by the FDA, as well as other pipeline products, including the ANDAs recently acquired from Akorn Holding Company, LLC.
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that meets FDA cGMP requirements. Saptalis manufactures and supplies to the US market multiple FDA approved prescription products. For more information, visit www.Saptalis.com.
Kesin Pharma Corporation, based in Oldsmar, FL, is a specialty pharmaceutical company with deep experience and strong capabilities in commercial sales & marketing, distribution, and market access. Kesin's mission is to provide unique healthcare solutions to patients through our portfolio of strategic, value-driven brand and unit-dose products. Kesin Pharma works closely with patients, payers, and provider partners to bring to market innovative pharmaceutical products t
Saptalis Pharmaceuticals, LLC announced today that it started shipping its products for distribution to US customers under its own label
Saptalis Pharmaceuticals, LLC announced today that it started shipping its products for distribution to US customers under its own label. The products - Triamcinolone Acetonide Topical Cream 0.1 % in 15, 30 and 80 gm tubes, are marketed by its newly formed Sales & Marketing team under the leadership of two experienced professionals:
Mike Lupo, Vice President, Sales & Marketing and Fayez Azeez, Vice President, Commercial Operations.
Mr. Lupo is responsible for all Sales and Marketing efforts involved with introducing, establishing and growing the Saptalis label and presence in the US Pharmaceutical market. Mr. Lupo has over 25 years of experience in marketing generic pharmaceutical products to all trade classes. During his career, he has held senior level Sales & Marketing positions at various generic pharma companies, including Ethex Corporation (KV), Boca Pharmacal, Inc, and Epic Pharma. Mr. Lupo holds a B.S. degree in Business Administration- Management from Rutgers University.
Mr. Azeez is responsible for commercial operations, including budgeting, forecasting, pricing analysis, 3PL relationship management, GTN calculation, revenue recognition, monthly and quarterly report calculation. Over his nearly 30-year career, Mr. Azeez has held high level positions at financial institutions and pharmaceutical companies, most recently at Strides Pharma, Inc and Micro Labs USA, Inc. During his tenure, he has been relied upon to develop business strategy and ensure operational efficiency. Mr. Azeez holds a BS degree in Finance from Rutgers University and MBA degree from Boston University.
The launch of Triamcinolone Acetonide Topical Cream will be followed by the introduction of additional products currently under review by the FDA, as well as other pipeline products, including the ANDAs recently acquired from Akorn Holding Company, LLC.
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that meets FDA cGMP requirements. Saptalis manufactures and supplies to the US market multiple FDA approved prescription products. For more information, visit www.Saptalis.com.
Saptalis Pharmaceuticals, LLC announced today that it signed the final agreement with the Chapter 7 trustee of the estates of Akorn holding company, LLC for acquisition of multiple products comprising 2 portfolios
Saptalis Pharmaceuticals, LLC announced today that it signed the final agreement with the Chapter 7 trustee of the estates of Akorn holding company, LLC for acquisition of multiple products comprising 2 portfolios.
One portfolio includes 15 ANDAs for non sterile liquid and semi-solid products, and an NDA for Acetic Acid/Hydrocortisone Otic Solution 2%/1% (Vosol HC). According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for the acquired products is approximately $115 million. Saptalis will transfer the products to its manufacturing facility in Hauppauge, NY and plans to commercialize them within the next 9-36 months. The products have limited generic competition and their addition to Saptalis portfolio of commercial products will significantly contribute to the Company growth. The products will be marketed by the Company Sales & Marketing team under Saptalis label.
Additional portfolio includes 18 ANDAs for sterile ophthalmic solutions and ointments. According to IQVIA, the current annual U.S. market for the acquired products is approximately $160 million. Many of the products, such as ophthalmic ointments, have limited or no competition in the US market. Saptalis is evaluating various options to monetize the opportunity in collaboration with industry partners.
Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility that meets FDA cGMP requirements. Saptalis manufactures and supplies to the US market multiple FDA approved prescription products. For more information, visit www.Saptalis.com.
Saptalis Pharmaceuticals, LLC announced today that it has received FDA approval for its ANDA for Levocarnitine Oral Solution 1gm/10mL
Saptalis Pharmaceuticals, LLC announced today that it has received FDA approval for its ANDA for Levocarnitine Oral Solution 1gm/10mL.
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. The product is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. Levocarnitine Oral Solution is a generic equivalent of Carnitor Oral Solution, Leadiant Biosciences, Inc. The product has annual sales of $12M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Cream 0
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Cream 0.1%. Triamcinolone Acetonide Cream is a topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The product has annual sales of $57M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its ANDA for Potassium Chloride Oral Solution, 20 MEQ/15mL and 40 MED/15mL
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its ANDA for Potassium Chloride Oral Solution, 20 MEQ/15mL and 40 MED/15mL.
The product is indicated for the treatment of patients with hypokalemia and for the prevention of hypokalemia in patients who would be at particular risk if hyperkalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias. Potassium Chloride Oral Solution has annual sales of $60M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Lotion 0
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Triamcinolone Acetonide Topical Lotion 0.1%.
The product is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Triamcinolone Acetonide Topical Lotion 0.1% has annual sales of $6M (IQVIA) and has limited generic competition. The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Erythromycin Topical Solution 2%
Saptalis Pharmaceuticals, LLC today announced that it has received FDA approval for its sANDA for Erythromycin Topical Solution 2%.
Erythromycin Topical Solution 2% is indicated for the topical treatment of acne vulgaris. The product has annual sales of $3M (IQVIA) and has limited generic competition. The Company will commercialize the product in collaboration with its marketing & distribution partner, Micro Labs USA.
Saptalis Pharmaceuticals, LLC today announced that it has received approval from the FDA for its sANDA for Acetic Acid Otic Solution USP, 2%
Saptalis Pharmaceuticals, LLC today announced that it has received approval from the FDA for its sANDA for Acetic Acid Otic Solution USP, 2%. Acetic Acid Otic Solution USP, 2% is indicated for the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. The product has limited generic competition and has annual sales of $3M (IQVIA). The Company will commercialize the product in collaboration with its marketing & distribution partner, TruPharma, LLC.
Saptalis Pharmaceuticals, LLC today announced that it has received final approval from the FDA for its ANDA for Metformin HCl Oral Solution 500 mg/5mL
Saptalis Pharmaceuticals, LLC today announced that it has received final approval from the FDA for its ANDA for Metformin HCl Oral Solution 500 mg/5mL.
Metformin HCl oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
The product is the only generic version of Riomet, Sun Pharmaceutical Industries, Inc. which in 2019, had annual sales of $15M (IQVIA). Saptalis was first generic company to file the ANDA containing a paragraph IV certification and successfully challenged the patent for Riomet. The FDA granted the Company a 180-day period of marketing exclusivity.
The Company will commercialize Metformin HCl Oral Solution in collaboration with its marketing & distribution partner Micro Labs, USA, Inc. and intends to ship the product before the end of March, 2020.
Saptalis Pharmaceuticals, LLC today announced that it has entered into an exclusive licensing agreement with Appili Therapeutics Inc
Saptalis Pharmaceuticals, LLC today announced that it has entered into an exclusive licensing agreement with Appili Therapeutics Inc. (TSXV: APLI) for manufacturing and commercialization of ATI-1501.
ATI-501 is a proprietary, novel, taste-masked oral liquid formulation of metronidazole a broad-spectrum and widely prescribed antibiotic used to treat parasitic and anaerobic bacterial infections which is being developed via the 505 (b) (2) pathway. Currently, oral metronidazole is only available as a solid tablet or capsule in the U.S. and Canada; no liquid oral dose forms are approved. An increasing number of patients with dysphagia (difficulty swallowing) are unable to take the tablet and require it to be crushed into food. This process amplifies the pronounced bitter taste, which can negatively impact patients adherence to their prescription.
Appili Therapeutics Inc, is a Halifax, Canada based biopharmaceutical company focused on anti-infective drug development. Appili will receive milestone and royalty payments on the sale of ATI-1501 in the U.S. Specific financial terms are not being disclosed.
Saptalis intends to initiate technology transfer to its manufacturing facility in Hauppauge and undertake all the necessary steps required for filing the NDA with the FDA.
Saptalis Pharmaceuticals, LLC today announced that it has received approval for the ANDA for Clobetasol Propionate Topical Solution, USP 0
Saptalis Pharmaceuticals, LLC today announced that it has received approval for the ANDA for Clobetasol Propionate Topical Solution, USP 0.05% (25mL and 50mL).
The product is a generic version of Embeline, Hi-Tech Pharmacal. The Company will commercialize Clobetasol Topical Solution in collaboration with its marketing & distribution partner Micro Labs, USA, Inc. and intends to ship the product before the end of 2019.