FDA: Recent Paragraph IV Patent Certifications

August 5, 2015, FDA announced that it received Abbreviated New Drug Application’s (ANDA) containing a “Paragraph IV” patent certification for the following drugs.

Drug Name Dosage Form Strength RLD Date of Submission
Carbidopa and Levodopa Extended-release Capsules 61.25 mg/245 mg Rytary 6/10/2015
Doxycycline Hyclate Delayed-release Tablets 80 mg Doryx 7/1/2015
Fidaxomicin Tablets 200 mg Dificid 5/27/2015
Oseltamivir phosphate Oral Suspension 6 mg/mL Tamiflu 6/18/2015
Phenylephrine and Ketorolac Injection 1%/0.3% Omidria 5/29/2015


Brief Description of the above Drugs:

i) Carbidopa and Levodopa:
Carbidopa is an aromatic amino acid decarboxylation inhibitor and Levodopa is an aromatic amino acid.

Rytary is a combination of Carbidopa and Levodopa which are approved for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Impax Labs Inc is the NDA (N203312) owner for Rytary (23.75MG; 95MG, 36.25MG; 145MG, 48.75MG; 195MG, 61.25MG; 245MG capsule, extended release; oral) which was approved on Jan 7, 2015, and it also received NDF exclusivity which is going to expire on Jan 7, 2018. There are several patents listed for the above combination which are set to expire on Dec 26, 2028.

ii) Doxycycline Hyclate (80 mg):
Doxycycline belongs to tetracycline class of compounds. It is a broad-spectrum antibiotic of the tetracycline class that is useful for the treatment of a number of infections, including bacterial, protozoal and helminth. Doxycycline was developed by Pfizer which first received FDA approval in 1967, pfizer marketed Doxycycline under the brand name Vibramycin.

Doryx Capsules contain specially coated pellets of Doxycycline Hyclate in a delayed-release formulation for oral administration. Mayne Pharma Intl received FDA approval for its NDA 050582 (capsule, delayed release;oral EQ 75MG and 100MG of Doxycycline Hyclate base), in July 22, 1985 which was discontinued later. Further, on May 6, 2005 Mayne Pharma received FDA approval for its NDA 050795 (tablet, delayed release;oral EQ 50, 75, 80, 100, 150, 200mg of Doxycycline Hyclate base). There are 2 patent listed in orange book for DORYX, which are US 6,958,161 (Dec 15, 2022) and US 8,715,724 (Feb 3, 2028).

iii) Fidaxomicin:
Fidaxomicin is a narrow spectrum macrocyclic antibiotic drug. Cubist Pharmaceuticals received FDA approval on May 27, 2011 for its NDA 201699, which is currently marketing Fidaxomicin under the brand name Dificid. There are several patents listed in OB for Dificid which claims polymorphic forms and compositions and etc., NCE is going to expire on May 27, 2016.

iv) Oseltamivir Phosphate:
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for:
a) Treatment of acute, uncomplicated influenza in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. (1.1)
b) Prophylaxis of influenza in patients 1 year and older. (1.2)

Roche received FDA approval to market Oseltamivir Phosphate as capsules containing 30 mg, 45 mg, or 75 mg Oseltamivir for oral use, in the form of Oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 mg/mL Oseltamivir base. Tamiflu is the brand name of Oseltamivir Phosphate.

The related patents listed in OB for Tamiflu are going to expire in 2015-2017. Its interesting to see for which patent the paragraph iv has been filed.

v) Phenylephrine and Ketorolac:
Omidria (phenylephrine and ketorolac injection) contains is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor which are indicated for:
Maintaining pupil size by preventing intraoperative miosis, Reducing postoperative pain

Omidria received FDA approval on May 30, 2014 which is marketed by Omeros.


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