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Press Release

  • 13 February 2020

    Jubilant Receives Favorable Rulings from the U.S. Patent Office Invalidating Bracco Rubidium-Infusion-System Patents

    Bracco had alleged that Jubilant’s RUBY-FILL® Generator and RUBY Rubidium Elution System™ were infringing the two patents in a lawsuit filed in 2018, prompting Jubilant to challenge the validity of the two patents in three Inter Partes Review (“IPR”) proceedings before the U.S. Patent Office. As a result of these favorable rulings, the U.S. Patent Office is expected to cancel all challenged claims of the two Bracco patents.

    This favorable decision from the U.S. Patent Office comes on the heels of another favorable ruling that Jubilant received in December 2019 from the U.S. International Trade Commission (“ITC”), which found three other Bracco patents directed to rubidium infusion systems invalid. The ITC proceeding was instituted in 2018 after Bracco filed a complaint with the ITC accusing Jubilant’s RUBY-FILL Generator and RUBY Rubidium Elution System of infringing the three patents. As a result of the ITC’s invalidity findings, the ITC found Jubilant had not violated section 337 of the Tariff Act of 1930 and terminated the proceeding in Jubilant’s favor.

    “These favorable rulings by the U.S. Patent Office and International Trade Commission further confirm Jubilant’s right to continue development and commercialization of RUBY-FILL in the U.S. marketplace and to continue focusing on our goal of bringing innovative products to the market for patients in need of the latest technology,” stated Pramod Yadav, CEO, Jubilant Pharma Limited.

    Jubilant Radiopharma’s RUBY-FILL Generator and RUBY Rubidium Elution System provide the latest and most advanced technology in PET Rubidium-82 myocardial imaging. RUBY-FILL provides customers a choice in the next generation product, with safety, efficiency, and automation advancements. Jubilant Radiopharma’s products are key in its greater commitment to investing in the growth and expansion of nuclear medicine in the global market.

    For more information on RUBY-FILL and the RUBY Rubidium Elution System’s technology features and benefits, please visit the website at www.RUBY-FILL.com or www.jubilantradiopharma.com.

    ABOUT JUBILANT RADIOPHARMA™: Jubilant Radiopharma, Radiopharmaceutical Division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.

    ABOUT JUBILANT PHARMA LIMITED: Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and awholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non- sterile products through 6 USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radio-pharmacies in the US. The Company has a team of over 4,300 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceuti companies globally.

  • 23 July 2019

    Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

    Company Contact:
    Kevin J. Fortier
    1-800-308-3985
    kevin.fortier@cadista.com

    Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801.

    As a result of the OOS dissolution results, product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

    Product Description: Drospirenone and Ethinyl Estradiol tablets are an estrogen/progestin combination oral contraceptive, indicated for use by women to:

      • Prevent pregnancy
      • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraceptio
      • Treat moderate acne for women at least 14 years old and/or if the patient desires an oral contraceptive for birth control

    Drospirenone and Ethinyl Estradiol tablets are packaged into a carton containing 3 blister cards. Each blister card contains 28-film coated, biconvex tablets, in the following order: 24 active pink-color round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol,  and four (4) inert white-color round, unscored, film-coated tablets debossed with a “PL”.

    The affected Drospirenone and Ethinyl Estradiol Tablets, USP, has been identified as Lot number 183222, with NDC number 59746-763-43 and expiration date of 11/2020.

    Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, lot 183222 was distributed Nationwide to wholesalers, distributors, and retailers.

    Jubilant Cadista Pharmaceuticals Inc. is notifying its customers by emailing a recall notification letter and response form and is arranging for return of all recalled product.
    Patients that have used the affected lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg should consult their healthcare provider. Patients may return the affected lot to their place of purchase.

    Wholesalers, distributors, and retailers should immediately examine their inventory for the affected lot. All inventory of the affected lot should be quarantined to prevent further distribution to patients.  Customers who purchased the impacted product directly from Jubilant Cadista Pharmaceuticals Inc. can call Inmar at 1-855-205-9246 (9:00 a.m. – 5:00 p.m. EDT, Monday – Friday) to arrange for their return.

    Consumers with additional questions regarding the recall may contact Jubilant Cadista by phone at 1-800-308-3985 (9:00 a.m. – 6:00 p.m. EDT, Monday – Friday). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

      • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
      • Regular Mail or Fax:
    Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

     

    Consumers/Patients: For answers to Frequently Asked Questions about this Recall, click here.

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