505(b)(2) – Q2 2024 approvals

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, …

Albuterol sulfate – USA

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



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 …

Paliperidone – USA

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 …

10 noteworthy successful 505b2 launches in last decade

The FDA’s 505(b)(2) pathway is a game-changer, offering a more efficient route to market for improved versions of existing drugs while ensuring they meet stringent safety and efficacy standards. This pathway strikes a balance between the lengthy process of discovering new molecules and the straightforward approach of making generic drugs, allowing companies to bring innovative products to market that address unresolved unmet needs.

While many 505(b)(2) products have entered the market, success stories are varied.

Rivaroxaban – UK

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 …

505b2 approvals – Apr. 2024

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



505b2 approvals of Q1 2024

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: …

Rifaximin – USA

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 …

Doxycycline – USA

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 …

Lurasidone – USA

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, …

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