Author: Mahendra Gunjal

1. CHEWTADZY (Tadalafil), Chewable tablet

Approval: Jun. 28, 2024

Applicant: B Better LLC

Indication: Erectile Dysfunction & Benign Prostatic Hyperplasia

PREA: Waived, because necessary studies are impossible or highly impracticable

Value addition: Alternate (Chewable) dosage form

2. PEMETREXED (Pemetrexed), Injection

Approval: Jun. 25, 2024

Applicant: Apotex

Indication: NSCLC & Pleural mesothelioma

PREA: Exempted, none of the PREA criteria apply to the application

Value addition: Different salt

3. TEPYLUTE (Thiotepa), Injection

Approval: Jun. 25, …

On Jun 10, 2024, New Jersey court denied Teva’s motion and granted Amneal’s motion for delisting of patent from Orange Book.

I. BACKGROUND

This case arises out of a patent infringement dispute under the Hatch-Waxman Act between Teva and Amneal. Teva holds approved NDA No. 021457 for ProAir® HFA (albuterol sulfate) Inhalation Aerosol (“ProAir® HFA”), and owns certain patents listed in the Orange Book as covering this product: U.S. Patent Nos. 8,132,712 (the “’712 …

On Jun 13, 2024, Delaware district court denied Tolmar’s motion for reconsideration.

Janssen Pharmaceuticals sued Tolmar, Inc. for patent infringement under the Hatch-Waxman Act. The case revolved around U.S. Patent No. 9,439,906 (“the ’906 patent”), which Janssen held. This patent is listed in OB for product, Invega Sustenna. Following a four-day bench trial, the court ruled in favor of Janssen, declaring the asserted claims of the ‘906 patent nonobvious over the prior art. The …

On May 24, 2024, UK Court of Appeal affirmed High Court’s decision of invalidity of once-daily method of use rivaroxaban patent.

Background: This case involves the revocation of European Patent (UK) No. 1 845 961 (the “Patent”), owned by Bayer and covering the use of rivaroxaban (marketed as Xarelto) for treating thromboembolic disorders through once-daily administration. The Patent was challenged by generic medicine suppliers who sought to market generic versions of rivaroxaban. On …

Here are below some recent 505b2 approvals with value additions and different approaches to address unmet need of patients.

1. XROMI (Hydroxyurea), Oral solution
Approval: Apr 04, 2024
Applicant: Nova Labs
Indication: sickle cell anemia with recurrent moderate to severe painful crises in pediatric patients aged 6 months of age to less than 2 years
PREA: Exempted because of orphan drug designation
Value addition: First oral liquid formulation for pediatric patients

2. RETEVMO …

Wondering what value additions 505b2 bring and how companies solve the unmet need. Look at below recent approvals of Q1 2024 to know more:

1. EOHILIA (Budesonide), Oral solution
Approval: Feb 09, 2024
Applicant: Takeda
Indication: For eosinophilic esophagitis (EoE)
Value addition: First and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).

2. LEGUBETI (Acetylcysteine lysine), For oral solution
Approval: Feb 13, 2024
Applicant: Galephar Pharma
Indication: …

On Apr. 11, 2024, Federal Circuit affirmed District court’s determination regarding obviousness, effective approval date of ANDA and motion to modify the final judgement.

Salix Pharmaceuticals contested a final judgment from the District of Delaware, which invalidated several of its patents (US 8,309,569; 10,765,667; 7,612,199; 7,902,206) as obvious. The patents in question pertained to the treatment of various conditions using rifaximin, a widely used antibiotic. Salix’s appeal focused on the invalidation of specific patent …

On Mar. 22, 2024, Delaware district court rejected plaintiff’s infringement theory as speculative without evidence.

In the case of Galderma v. Lupin, Galderma holds patents for a doxycycline capsule called Oracea, used for inflammatory lesions of rosacea. Oracea’s patented formulation consists of an immediate-release portion containing about 30 mg of doxycycline and a delayed-release portion containing about 10 mg of doxycycline, coated to release at a higher pH level in the small intestine. Galderma …

On Apr. 05, 2024, Federal Circuit vacated PTAB’s decision in an IPR and remanded the case for the PTAB to dismiss the  proceedings as the case got moot.

Sumitomo Pharma Co., Ltd. owned a patent (U.S. Patent No. 9,815,827) titled “Agent for Treatment of Schizophrenia,” which detailed dosing regimens for treating certain psychotic disorders with lurasidone, a pharmaceutical compound. The patent specifically claimed dosing regimens that treated schizophrenia without causing clinically significant weight gain, …