API and IP Newsletter

 Contents

• ANDA approvals in August 2023

• General information

• FDA finalizes guidance on standards for tracing products through supply chain

• Generative AI Drugs Are Coming

• Intellectual Property

• Alexon Vs Amgen: Orphan Drug Exclusivity in Europe

ANDA approvals in August 2023

We follow ANDA approvals of Indian companies each month. In August there are about 120 ANDA approvals, out of which 68 ANDAs approvals of for Indian companies. 

Sun pharma, Lupin received five approvals each. Alembic and Amneal received approvals for four each. 

Some of our observations are as below:

Drug Name	Company	Comments
PERMETHRIN          ANDA  #209732	DR REDDYS	This is 5% topical cream. Here RLD is Padagis product. It is mainly used for the treatment of head lice. US market size information is not available in public domain but global market size is about USD 200 mio. There are three other ANDAs approved. This is an old product, Permethrin was discovered in 1973. In 2020, it was the 427th most commonly prescribed medication in the United States, with more than 100,000 prescriptions.
VARENICLINE TARTRATE.              ANDA  #214255	MANKIND PHARMA	This approval is for 0.5 MG and 1 MG tablets. This is Pfizer's smoking cessation product. Par had received approval in August 2021 and was eligible for 180 days of shared generic drug exclusivity for  0.5 mg and 1 mg tablets. There are several approvals and this must be vanilla generic product in US by now.
BRIMONIDINE TARTRATE.             ANDA  #216909	ALEMBIC	This approval is for 0.1% ophthalmic solution. Apotex and Sandoz have also received approvals. Apotex launched the product on 5 September 2023. US sale was about $ 97 mio for the year ended in December 2022.
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE. ANDA  #217340	DR REDDYS	This approval is for ER tablets. OTC. Cough suppressant. There are many other approvals. This is about $ 70/a product in USA.
INDOMETHACIN.  ANDA  #216184	ZYDUS	This is suppository, rectal administration, 50 MG. This very old product. The company had received 180 days CGT exclusivity, this is $ 95 mio product in USA for the year ended in March 2023.

General information

FDA finalizes guidance on standards for tracing products through the supply chain.

The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email exchanges to accommodate the needs of smaller pharmacies who may not have the encrypted Internet connections for exchanging of Electronic Product Code Information Services (EPCIS) information. 

News here.

Generative AI Drugs Are Coming

Just as ChatGPT is turning text directions into new written materials, or just as DALL-E 2 produces realistic-looking images from prompts, generative AI is now being used to turn scientists’ directions for molecules with specific characteristics into new drugs for diseases including cancer, Alzheimer's, arthritis, fibrosis and other rare diseases. 

News here

Intellectual Property 

Alexon Vs Amgen: Orphan Drug Exclusivity in Europe

Orphan Drug Exclusivity (ODE) challenges are not very common in Europe. 

There is a recent decision by Munich Regional Court in the dispute between Alexion and Amgen over the biologic Soliris for the treatment of rare blood diseases. The drug is eculizumab. In this decision Hon Court addressed the question of ODE.

Orphan Drugs are used to treat rare diseases and EU health agency offers 10 years market exclusivity. 

Brief background of the case is as follows.

1. Alexion sells a drug approved for four rare diseases: Paroxysmal Nocturnal Hemoglobinuria ("PNH"), Atypical Hemolytic Uremic Syndrome ("aHUS"), Refractory Generalized Myasthenia Gravis ("gMG"), and Neuromyelitis Optica Spectrum Disorders (“NMOSD”). 

2. For three of the diseases, namely aHUS, gMG and NMOSD, in addition to marketing authorization, it also holds exclusivity rights for orphan diseases

3. In August 2022, Amgen announced the development of ABP 959, a biosimilar candidate to Soliris for the treatment of PNH. 

4. According to Amgen, ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed monoclonal antibody eculizumab in the US and the EU.

5. In April 2023, Amgen received MA from EMEA for its eculizumab product ie ABP 959. 

6. Amgen started marketing eculizumab under brand name Bekemv. Bekemv, was approved exclusively for the treatment of PNH for which the market exclusivity of the original product Soliris has expired.

7. Alexion did not question the approval of Bekemv in the current dispute. Rather, Alexion was concerned with preventing possible cross-label use of the biosimilar for other indications.

Alexion initially obtained an ex-parte injunction from Munich Regional Court in May 2023 to prevent off-label use. 

Amgen had to take various measures to ensure Bekemv was not used to treat any of the three indications that are still protected. 

Amgen appealed against this ex-parte injunction decision.

1. Civil Chamber of the Munich District Court, which is responsible for patent law, largely confirmed the temporary injunction issued for violating the right to market exclusivity for rare diseases 

2. The Chamber was of the opinion that Amgen, have made an adequate, causal contribution to the cross-indication use of their medication through letters of recommendation, including in the three indications protected by Alexion.  

3. The legal consequence is the order not to sell the drug in question without certain protective measures.

It seems this is the first time a court in Europe has opined on the question of whether the market exclusivity of orphan drugs can also be enforced against competitors. 

Decision here